Ticker Homepage

Key Metrics

Market Cap
Total Shares Outstanding
Book Value
PE Ratio

PS Ratio
PB Ratio
Forward PE Ratio
ROIC

Return on Aseets
Return on Equity
Dividend
Dividend Yield

Balancesheet Metrics

Total Assets
Total Liability
Assets-to-Libability Ratio

Total Current Assets
Total Current Liability
Current Ratio

Quick Ratio
Debt to Equity Ratio

Income Statement Metrics

Net Income
EPS
EBITA

Gross Profit
Gross Profit Margin
Operating Margin

Net Profit Margin

Price Metrics

5 Days MA
10 Days MA
20 Days MA
50 Days MA
200 Days MA

52 Weeks High
52 Weeks low
All Time High

RSI
MACD

Share Stats

Shares Float
Shares Short

% Short
% Insider

% Institutions

% Institutions

News

Fortress Biotech to Present at the BTIG Virtual Biotechnology Conference 2023Fortress Biotech, Inc. MIAMI, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today ann...
Fortress Biotech, Inc. MIAMI, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate overview at the BTIG Virtual Biotechnology Conference on Tuesday, August 8, 2023 at 12:00 PM ET. The Company will also attend virtual one-on-one meetings during the conference. For more information or to join the conference, email info@btig.com. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has eight marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca plc, City of Hope, Fred Hutchinson Cancer Center, St. Jude Children’s Research Hospital, Nationwide Children’s Hospital and Sentynl Therapeutics, Inc. For more information, visit www.fortressbiotech.com. Story continues Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs, ability to generate shareholder value, ability of our products to receive necessary approvals, including FDA approval, ability of our products and therapies to help patients and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials, including disruptions that may result from hostilities in Europe; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Company Contact: Jaclyn Jaffe Fortress Biotech, Inc. (781) 652-4500 ir@fortressbiotech.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com
FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Mustang Bio to Participate in Two August 2023 Investor ConferencesMustang Bio, Inc. WORCESTER, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare...
Mustang Bio, Inc. WORCESTER, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in two investor conferences in August 2023. Details of the events are as follows: BTIG Virtual Biotechnology Conference 2023: The company will present a corporate update on Tuesday, August 8, 2023, at 9:00 a.m. ET and will participate in one-on-one meetings during the conference. For more information or to join the conference, email info@btig.com. H.C. Wainwright Immune Cell Engager Virtual Conference: The company will participate in a fireside chat on Thursday, August 17, 2023, at 3:00 p.m. ET and will attend one-on-one meetings during the conference. A webcast of the company’s fireside chat will be available on the News & Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the conference. About Mustang Bio Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR-T therapies across multiple cancers, as well as lentiviral gene therapies for severe combined immunodeficiency. Mustang’s common stock is registered under the Securities Exchange Act of 1934, as amended, and Mustang files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.mustangbio.com. Story continues Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. The Company’s forward-looking statements, include, but are not limited to, any statements relating to our growth strategy and product development programs, including the timing of and our ability to make regulatory filings such as INDs and other applications and to obtain regulatory approvals for our product candidates, statements concerning the potential of therapies and product candidates and any other statements that are not historical facts. Actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties. Risks and uncertainties include, among other things, risks related to whether Company’s third-party manufacturer is able to successfully perform its obligation to produce the Company’s products under the manufacturing services agreement on a timely basis and to acceptable standards; disruption from the sale of the Company’s manufacturing facility making it more difficult to maintain business and operational relationships; negative effects of the announcement of the consummation of the sale of the Company’s manufacturing facility on the market price of the Company’s common stock; significant transaction costs; the development stage of the Company’s primary product candidates, our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K filed on March 30, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact: Jaclyn Jaffe Mustang Bio, Inc. (781) 652-4500 ir@mustangbio.com Investor Relations Contact: Daniel Ferry LifeSci Advisors, LLC (617) 430-7576 daniel@lifesciadvisors.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com
FBIO FBIOP MBIO | finance.yahoo | about 2 years ago | Neutral

Journey Medical Corporation to Announce Second Quarter 2023 Financial Results on August 8, 2023Journey Medical Corporation Company to host conference call to discuss financial results and provide a corporate update on August 8, 2023 at 4:30 p.m. ET Company and Neal Bhatia, MD, Director of Clinical Dermatology, Therapeutics Clinical Research, San Diego, CA and Investigator in over 75 clinica...
Journey Medical Corporation Company to host conference call to discuss financial results and provide a corporate update on August 8, 2023 at 4:30 p.m. ET Company and Neal Bhatia, MD, Director of Clinical Dermatology, Therapeutics Clinical Research, San Diego, CA and Investigator in over 75 clinical trials including the DFD-29 Phase 3 clinical program, to discuss positive topline clinical data and disease state of rosacea on the conference call SCOTTSDALE, Ariz., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical” or the “Company”) (Nasdaq: DERM), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced the Company will release its second quarter 2023 financial results after the U.S. financial markets close on Tuesday, August 8, 2023. Journey Medical management and Neal Bhatia, MD, Director of Clinical Dermatology, Therapeutics Clinical Research, San Diego, CA and an investigator in over 75 clinical trials including the DFD-29 Phase 3 clinical program, will conduct a conference call and audio webcast on Tuesday, August 8, 2023 at 4:30 p.m. ET. To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to join the Journey Medical conference call. Participants can register for the conference by navigating to https://dpregister.com/sreg/10181142/f9fee9e324. Please note that registered participants will receive their dial-in number upon registration. A live audio webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com, and will remain available for replay for approximately 30 days after the conference call. About Journey Medical Corporation Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The company currently markets eight branded and three generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Story continues Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful development and regulatory approval of the DFD-29 product candidate and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact: Jaclyn Jaffe Journey Medical Corporation (781) 652-4500 ir@jmcderm.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com
DERM FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Insiders Re-Evaluate Their US$3.4m Stock Purchase As Fortress Biotech Falls To US$77mInsiders who acquired US$3.4m worth of Fortress Biotech, Inc.'s (NASDAQ:FBIO) stock at an average price of US$0.83 in the past 12 months may be dismayed by the recent 12% price decline. Insiders purchase with the hope of seeing their investments increase in value over time. However, due to recent lo...
Insiders who acquired US$3.4m worth of Fortress Biotech, Inc.'s (NASDAQ:FBIO) stock at an average price of US$0.83 in the past 12 months may be dismayed by the recent 12% price decline. Insiders purchase with the hope of seeing their investments increase in value over time. However, due to recent losses, their initial investment is now only worth US$2.4m, which is not great. While insider transactions are not the most important thing when it comes to long-term investing, logic dictates you should pay some attention to whether insiders are buying or selling shares. Check out our latest analysis for Fortress Biotech The Last 12 Months Of Insider Transactions At Fortress Biotech In the last twelve months, the biggest single purchase by an insider was when Executive Chairman Lindsay Rosenwald bought US$2.0m worth of shares at a price of US$0.83 per share. That means that even when the share price was higher than US$0.57 (the recent price), an insider wanted to purchase shares. It's very possible they regret the purchase, but it's more likely they are bullish about the company. In our view, the price an insider pays for shares is very important. Generally speaking, it catches our eye when insiders have purchased shares at above current prices, as it suggests they believed the shares were worth buying, even at a higher price. While Fortress Biotech insiders bought shares during the last year, they didn't sell. You can see a visual depiction of insider transactions (by companies and individuals) over the last 12 months, below. If you want to know exactly who sold, for how much, and when, simply click on the graph below! insider-trading-volume Fortress Biotech is not the only stock insiders are buying. So take a peek at this freelist of growing companies with insider buying. Insider Ownership Looking at the total insider shareholdings in a company can help to inform your view of whether they are well aligned with common shareholders. Usually, the higher the insider ownership, the more likely it is that insiders will be incentivised to build the company for the long term. It appears that Fortress Biotech insiders own 26% of the company, worth about US$20m. This level of insider ownership is good but just short of being particularly stand-out. It certainly does suggest a reasonable degree of alignment. Story continues What Might The Insider Transactions At Fortress Biotech Tell Us? There haven't been any insider transactions in the last three months -- that doesn't mean much. But insiders have shown more of an appetite for the stock, over the last year. Insiders own shares in Fortress Biotech and we see no evidence to suggest they are worried about the future. So these insider transactions can help us build a thesis about the stock, but it's also worthwhile knowing the risks facing this company. In terms of investment risks, we've identified 4 warning signs with Fortress Biotech and understanding these should be part of your investment process. But note: Fortress Biotech may not be the best stock to buy. So take a peek at this freelist of interesting companies with high ROE and low debt. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions, but not derivative transactions. Have feedback on this article? Concerned about the content?Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Join A Paid User Research Session You’ll receive a US$30 Amazon Gift card for 1 hour of your time while helping us build better investing tools for the individual investors like yourself. Sign up here
FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Avenue Therapeutics Announces High Potency and Full Efficacy in a Model of Generalized Seizures for its Novel GABA-A Receptor Potentiator, BAER-101, Supporting Phase 2 Clinical StudyAvenue Therapeutics -A Phase 2a study of BAER-101 in epilepsy is planned to initiate in 2024 MIAMI, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapi...
Avenue Therapeutics -A Phase 2a study of BAER-101 in epilepsy is planned to initiate in 2024 MIAMI, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, announced today that BAER-101, the Company’s potentially best-in-class selective GABA-A α2,3 positive allosteric modulator (“PAM”), significantly suppressed seizures in a translational animal model of absence epilepsy. “These preclinical results demonstrate the potential of BAER-101 to improve the current treatment landscape of epilepsy with a differentiated approach designed to improve the safety profile compared to existing drugs, which are often not well-tolerated due to side effects including sedation, cognitive impairment, ataxia and addiction,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “As we advance toward potentially initiating a Phase 2a study in 2024, we are encouraged by these results, showing BAER-101’s best-in-class potential for patients with increased tolerability, potency and efficacy.” BAER-101 underwent preclinical in vivo evaluation in SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy. The GAERS model mimics behavioral, electrophysiological and pharmacological features of human absence seizures. The GAERS model is a proven, early, informative indicator of efficacy in anti-seizure drug development, with high predictability of response in humans. In the model, BAER-101 demonstrated full suppression of seizure activity with a minimal effective dose of 0.3 mg/kg, PO. The effect was fast in onset and stable throughout the duration of testing. BAER-101 has previously been shown to be safe with minimal side effects in clinical studies of hundreds of patients in a program targeting a different indication by AstraZeneca. The combination of safety, tolerability and efficacy in an established translationally relevant epilepsy model support BAER-101’s continued development. The selective potentiation of alpha 2,3-containing GABA-A receptors with minimal impact on α1 and α5-containing GABA-A receptors differentiates BAER-101 from competitors, and predicts a lower potential for sedation, motor incoordination, cognitive impairment and/or tolerance. Further study of the anti-seizure properties of BAER-101 is being planned in patients with focal seizures and other seizure disorders for which current treatments are not fully efficacious. Story continues “As an experienced neurologist treating patients with epilepsy, I believe the potency, tolerability and efficacy of BAER-101 is exciting, as it creates an opportunity to improve the treatment of seizures in a field where many of the approved treatments have limited efficacy and/or are dose-limited by side effects,” said Amy Chappell, M.D., FAAN, experienced neuroscience drug developer, former Eli Lilly and Company executive, and consultant to the Company. The detailed study results are expected to be presented at an upcoming scientific meeting. About BAER-101 Avenue is developing BAER-101 via its subsidiary Baergic Bio for epilepsy disorders. BAER-101 is a PAM of α2,3 subunit‐containing GABA-A receptors with minimal activity at α1 or α5‐containing receptors, which are believed to mediate many of the issues impacting the medical use of benzodiazepines such as those noted with diazepam use (tolerance, dependence, abuse, sedation and impaired cognition). As a result, BAER-101 may have the potential to treat epilepsy, anxiety and other disorders in which benzodiazepines are currently used, while minimizing the benzodiazepine associated adverse effects. BAER-101 was licensed in from AstraZeneca with a large safety database in over 700 patients and an efficacy signal in a subset of patients with anxiety. About Epilepsy Absence epilepsy is a form of epileptic syndrome where patients show generalized non-convulsive seizures characterized by a brief unresponsiveness to environmental stimuli and cessation of activity. In human, typical absence seizures are associated with bilateral, synchronous and regular spike-and-wave discharges (“SWD”). SynapCell's world-exclusive model, the GAERS, displays spontaneous SWD and has become the “state of the art” translational a reference model for the past thirty years. Most of the drugs that have been studied in the GAERS model work in focal as well as generalized seizures in humans. About Avenue Therapeutics Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. The Company is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABA-A α2/3 receptor positive allosteric modulator for CNS diseases, and IV Tramadol, which is in Phase 3 clinical development for the management of moderate-to-moderately-severe pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com. Forward-Looking Statements This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: expectations for increases or decreases in expenses; expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidate or any other products we may acquire or in-license; our use of clinical research centers and other contractors; expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities; expectations for generating revenue or becoming profitable on a sustained basis; expectations or ability to enter into marketing and other partnership agreements; expectations or ability to enter into product acquisition and in-licensing transactions; expectations or ability to build our own commercial infrastructure to manufacture, market and sell our product candidates; acceptance of our products by doctors, patients or payors; our ability to compete against other companies and research institutions; our ability to secure adequate protection for our intellectual property; our ability to attract and retain key personnel; availability of reimbursement for our products; estimates of the sufficiency of our existing cash and cash equivalents and investments to finance our operating requirements, including expectations regarding the value and liquidity of our investments; the volatility of our stock price; expected losses; expectations for future capital requirements; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn Jaffe Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com
ATXI FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Mustang Bio Announces Amendment and Closing of Strategic Manufacturing Partnership Transaction with uBriGene (Boston) BiosciencesMustang Bio, Inc. Transaction and reduction in operating expenses enhance Mustang’s cash position WORCESTER, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical bre...
Mustang Bio, Inc. Transaction and reduction in operating expenses enhance Mustang’s cash position WORCESTER, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced that, on July 28, 2023, it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc. (“uBriGene”), the U.S. subsidiary of uBriGene Group, a leading cell and gene therapy contract development and manufacturing organization (“CDMO”) and closed the transaction under the terms of the amended asset purchase agreement. Per the terms of the amended agreement, at closing, uBriGene acquired all of Mustang’s assets primarily relating to the manufacturing and production of cell and gene therapies for upfront consideration of $6 million in cash. Mustang’s lease to the premises in Worcester, Massachusetts where its state-of-the-art clinical- and commercial-scale cell and gene therapy manufacturing facility is located (and related contracts and manufacturing personnel) did not transfer at closing because such transfer requires the consent of the landlord, which has requested additional time to consider the proposed transfer. An additional $5 million contingent payment (less any outstanding liabilities relating to transferred contracts and employees) will be payable to Mustang upon (i) Mustang’s raising $10 million in gross proceeds from equity raises following the closing of the transaction and (ii) completion of the assignment of Mustang’s lease to uBriGene, which remains subject to landlord’s approval. Unless and until the lease is transferred to uBriGene, Mustang will retain its facility lease and facility personnel, and will continue to occupy the leasehold premises and manufacture there its lead product candidate, MB-106. Story continues The amended asset purchase agreement provides that Mustang will continue to work with uBriGene to secure the assignment of its manufacturing facility lease, which would complete the transfer of its facility to uBriGene as originally planned. The Company and uBriGene expect to complete their filing of a joint voluntary notice to obtain clearance for the transaction from the U.S. Committee on Foreign Investment in the United States (“CFIUS”) no later than August 31, 2023. It is expected that CFIUS may take up to 90 days to complete its review, after which Mustang’s landlord has informed the Company that it will require an additional 30 days to review the request for consent to assign the lease. If, after 120 days from the date of closing, the lease has not transferred to uBriGene, uBriGene may request the parties use their best commercial efforts to negotiate in good faith a repurchase by Mustang of the transferred assets and assumed liabilities acquired on the date of closing. Under the terms of the amended asset purchase agreement, the lease of the facility and related contracts are to be transferred to uBriGene within three business days following receipt of the landlord’s consent to the proposed lease transfer, and Mustang employees who support the transferred operations and have accepted offers of employment with uBriGene will become employees of uBriGene effective on the date that is 30 days following the completion of the lease transfer. At closing, Mustang and uBriGene also entered into a manufacturing services agreement, under which Mustang contracted uBriGene to manufacture Mustang’s lead product candidates. This includes the manufacturing of MB-106, the Company’s first-in-class CD20-targeted autologous CAR T therapy, for the ongoing multi-center Phase 1/2 trial in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia. Pending the landlord’s determination regarding transfer of the facility lease to uBriGene, Mustang and uBriGene also have entered into a second manufacturing services agreement, under which Mustang will serve as uBriGene’s contract development and manufacturing provider and will continue to manufacture MB-106, as well as potentially other cell and gene therapies, in exchange for compensation to be equal to Mustang’s operating costs associated with the performance of such services. Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, commented, “We are very pleased to have closed this strategic transaction with uBriGene. This transaction will allow Mustang to optimize its resources and focus on advancing our lead clinical-stage programs in order to achieve multiple near-term milestones, while significantly reducing our operating expenses and enhancing our cash position. We look forward to reporting initial clinical data from our MB-106 multicenter program soon.” The upfront proceeds from the transaction and recent reductions in operating expenses relating to Mustang’s portfolio along with resource optimization are expected to extend the Company’s cash runway into early 2024. The Worcester facility is a 27,000 square foot, cutting-edge cGMP facility supporting process development, manufacturing and analytical testing, designed with the flexibility to expand and support various cell and gene therapy production requirements and capacities. “Our transaction with Mustang will permit the expansion of the Worcester site’s capabilities while leveraging Mustang’s experienced staff and robust quality and operating systems to manufacture a broader portfolio of advanced modalities,” said Alex Chen, President of uBriGene. “uBriGene will also offer its expertise in preclinical research services and late-stage and commercial manufacturing of advanced therapy products with respect to product and process characterization, and regulatory inspections.” Upon transfer of the lease to uBriGene, Mustang’s headquarters will relocate to 1 Mercantile Street, in Worcester, MA. Mustang has filed a Current Report on Form 8-K, dated July 31, 2023 (the “Form 8-K”), with the U.S. Securities and Exchange Commission (the "SEC"), relating to the amended asset purchase agreement and closing of the transaction described in this press release. You are encouraged to refer to the Form 8-K for a more complete description of the material terms of the amended asset purchase agreement, the manufacturing services agreements, the transaction, the closing, and related matters. About uBriGene (Boston) Biosciences Inc. uBriGene (Boston) Biosciences Inc. is dedicated to providing one-stop CDMO services for cell and gene therapy. It has established integrated innovative biologics CDMO platforms that provide GMP-level plasmid preparation, viral packaging, and T-cell production services for CAR-T productions, supporting the preclinical to clinical and commercial stages. In addition, the company also provides viral vectors, including adeno-associated viral and lentiviral vectors to meet the demands of research and/or manufacturing applications. With its fermentation capacity ranging from 5L to 500L, uBriGene offers a versatile selection of research-grade, GMP-ready, or GMP-grade plasmids for research and clinical applications respectively. uBriGene currently operates two state-of-the-art GMP facilities, including 21 clean suites with a total area of over 133,000 sq ft. For more information, visit www.ubrigene.com. About Mustang Bio Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR-T therapies across multiple cancers, as well as lentiviral gene therapies for severe combined immunodeficiency. Mustang’s common stock is registered under the Securities Exchange Act of 1934, as amended, and Mustang files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.mustangbio.com. Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. The Company’s forward-looking statements, include, among others, statements about the Company’s expectations with respect to the consummation of the sale of its manufacturing facility and its ability to fund its operations, including continued investment in its research and development pipeline; the Company’s potential receipt of the $5 million contingent payment; and the Company’s anticipated savings and expenses relating to the consummation of the sale of its manufacturing facility. Actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties. Risks and uncertainties include, among other things, risks related to receipt of a favorable determination regarding the transaction from CFIUS; receipt of the landlord’s consent to transfer the facility lease to uBriGene; whether uBriGene is able to successfully perform its obligation to produce the Company’s products under the Manufacturing Services Agreement on a timely basis and to acceptable standards; whether the Company is able to raise $10 million in gross proceeds from equity raises following the closing of the transaction and receive the contingent portion of the consideration for the sale of the manufacturing facility to uBriGene; whether the Company’s expenses are as predicted; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the announcement or the consummation of the transaction on the market price of the Company’s common stock; significant transaction costs; the development stage of the Company’s primary product candidates and the related risks involved in drug development, clinical trials and the uncertainties around regulatory reviews and approvals; other business effects, including the effects of industry, market, economic, political or regulatory conditions; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K filed on March 30, 2023, subsequent Reports on Form 10-Q, and our other filings the Company makes with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contacts: Jaclyn Jaffe Mustang Bio, Inc. (781) 652-4500 ir@mustangbio.com Connie Zhang uBriGene (Boston) Biosciences Inc. 604-800-4613 info@ubrigene.com Investor Relations Contact: Daniel Ferry LifeSci Advisors, LLC (617) 430-7576 daniel@lifesciadvisors.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com
FBIO FBIOP MBIO | finance.yahoo | about 2 years ago | Neutral

Checkpoint Therapeutics Announces $10 Million Registered Direct Offering Priced At-the-MarketCheckpoint Therapeutics, Inc WALTHAM, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into a definitive agreement for the issuance and sale of an a...
Checkpoint Therapeutics, Inc WALTHAM, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,236,248 shares of its common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 3,236,248 shares of common stock and Series B warrants to purchase up to 3,236,248 shares of common stock, at a purchase price of $3.09 per share of common stock (or pre-funded warrant in lieu thereof) and associated warrants, in a registered direct offering priced at-the-market. The Series A warrants will be exercisable immediately upon issuance and will expire five years following the issuance date and have an exercise price of $2.84 per share and the Series B warrants will be exercisable immediately upon issuance and will expire eighteen months following the issuance date and have an exercise price of $2.84 per share. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering. The closing of the offering is expected to occur on or about July 31, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10 million. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including the manufacturing of cosibelimab and certain pre-commercial activities in anticipation of potential approval and commercial launch. The securities described above are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333-270843) that was previously filed with the Securities and Exchange Commission (“SEC”) on March 24, 2023, and subsequently declared effective on May 5, 2023. The securities offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at placements@hcwco.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Checkpoint Therapeutics Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing open-label, multi-regional, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including cohorts in metastatic and locally advanced cutaneous squamous cell carcinoma (“cSCC”) intended to support one or more applications for marketing approval. Based on positive topline and interim results in metastatic and locally advanced cSCC, respectively, Checkpoint submitted a Biologics License Application (“BLA”) for these indications in January 2023, which application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to the timing and completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of proceeds therefrom, as well as statements regarding the U.S. Food and Drug Administration (“FDA”) review of the BLA for the approval of cosibelimab for the treatment of patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation and the commercial potential of cosibelimab if the BLA is approved, statements relating to the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, the two-fold mechanism of action of cosibelimab translating into potential enhanced efficacy, and our projections of publication and regulatory review timelines. Factors that could cause our actual results to differ materially include the following: the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company Contact: Jaclyn Jaffe Checkpoint Therapeutics, Inc. (781) 652-4500 ir@checkpointtx.com Investor Relations Contact: Ashley R. Robinson Managing Director, LifeSci Advisors, LLC (617) 430-7577 arr@lifesciadvisors.com Media Relations Contact: Katie Kennedy Gregory FCA 610-731-1045 checkpoint@gregoryfca.com
CKPT FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Avenue Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)Avenue Therapeutics Topline data expected in 2024 MIAMI, July 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases...
Avenue Therapeutics Topline data expected in 2024 MIAMI, July 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease. A recent study used genetic analysis to estimate disease prevalence of 1:6,887 males.1 AJ201 is currently the lead drug candidate in the clinic for SBMA and enrollment in the trial is expected to be complete by the end of 2023 or early 2024 with potential topline data in 2024. “We are excited to announce that the first patient has been dosed in our Phase 1b/2a clinical trial evaluating AJ201 for the treatment of SBMA, a progressive and devastating neurodegenerative disease that currently has no approved treatments available,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “We are encouraged by the Phase 1 clinical data of AJ201 that demonstrate the drug’s excellent safety profile in healthy volunteers. Additionally, compelling preclinical data in a mouse model showed efficacy signals, including improvement in motor function, robust degradation of mutant androgen receptors (“AR”), a disease-signaling protein, and activation of the Nrf1 and Nrf2 pathways. In this Phase 1b/2a clinical trial, we aim to demonstrate how AJ201’s novel, multi-fold mechanism of action reduces accumulation of mutant AR aggregates to potentially decrease neuroinflammation, protect cells from oxidative stress, and ultimately, improve clinical outcomes for SBMA patients. We look forward to advancing this much needed drug, as we continue to deliver on our mission of bringing impactful therapies to people suffering from neurologic diseases.” The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 is expected to enroll approximately 24 patients, randomly assigned to AJ201 (600 mg/day) or placebo. The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacodynamic data measuring change from baseline in mutant AR protein levels in skeletal muscle and changes in the fat and muscle composition as seen on MRI scans, which are believed to be biomarkers indicating likelihood for longer term clinical improvement. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603). Story continues About Spinal and Bulbar Muscular Atrophy Spinal and bulbar muscular atrophy (“SBMA”) is a rare, X-linked genetic neuromuscular disease primarily affecting men. The condition is caused by the trinucleotide CAG repeat expansion in the androgen receptor (“AR”) which leads to production of a mutant polyglutamine (“polyQ”) AR protein that forms aggregates responsible for muscular atrophy focused in the limbs and bulbar region of the body. The weakening of the bulbar muscles affects chewing, speech and swallowing, with patients prone to choking or inhaling foods or liquids, resulting in airway infection. SBMA also affects muscles in the limbs, leading to difficulty walking and injury caused by falling. Although there is a range of cited prevalence rates in scientific literature, a recent study used genetic analysis to estimate disease prevalence of 1:6,887 males.1 Currently, there are no treatments approved by the U.S. Food and Drug Administration or European Medicines Agency available for patients. For more information about SBMA, also known as Kennedy’s Disease, please visit https://kennedysdisease.org/. About AJ201 AJ201 is a novel, first-in-class asset in development for the treatment of spinal and bulbar muscular atrophy. It was designed to modify SBMA through multiple mechanisms including degradation of the abnormal androgen receptor protein and by stimulating the Nrf1 and Nrf2 pathways, which are involved in protecting cells from oxidative stress which can lead to cell death. A first-in-human Phase 1 study of AJ201 in 72 healthy volunteers revealed an excellent safety and pharmacokinetic profile. It is currently being studied in a Phase 1/2a multicenter, randomized, double-blind clinical trial in six clinical sites across the U.S., which aims to evaluate the safety, PK/PD data and clinical response of AJ201 in patients suffering from SBMA. AJ201 has been granted Orphan Drug Designation by the FDA for multiple polyQ diseases, including SBMA, Huntington’s disease and spinocerebellar ataxia. Avenue exclusively licensed AJ201 from AnnJi Pharmaceuticals in the United States, Canada, European Union, Great Britain, and Israel. About Polyglutamine diseases Polyglutamine diseases are a group of neurodegenerative disorders caused by expanded CAG repeats encoding a long polyQ tract in the affected proteins. To date, a total of nine polyQ disorders have been described. Mutant protein aggregation in affected tissues is the pathological hallmark of polyQ diseases. Neuroinflammation, oxidative stress and dysregulated protein quality control are thought to be key pathological factors that are either direct results of mutant protein aggregations and/or exacerbate the severity and progression of the diseases. Modulating multiple cellular pathways in enhancing degradation of mutant AR aggregates, inducing antioxidant and heat shock responses, and increasing proteasome expression simultaneously provide the rationale to develop AJ201 for the treatment of SBMA and potentially other polyQ diseases. About Avenue Therapeutics Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class oral small molecule for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABA-A α2/3 receptor positive allosteric modulator for CNS diseases, and IV Tramadol, which is in Phase 3 clinical development for the management of moderate-to-moderately-severe pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com. Forward-Looking Statements This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: expectations for increases or decreases in expenses; expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidate or any other products we may acquire or in-license; our use of clinical research centers and other contractors; expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities; expectations for generating revenue or becoming profitable on a sustained basis; expectations or ability to enter into marketing and other partnership agreements; expectations or ability to enter into product acquisition and in-licensing transactions; expectations or ability to build our own commercial infrastructure to manufacture, market and sell our product candidates; acceptance of our products by doctors, patients or payors; our ability to compete against other companies and research institutions; our ability to secure adequate protection for our intellectual property; our ability to attract and retain key personnel; availability of reimbursement for our products; estimates of the sufficiency of our existing cash and cash equivalents and investments to finance our operating requirements, including expectations regarding the value and liquidity of our investments; the volatility of our stock price; expected losses; expectations for future capital requirements; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn Jaffe Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com —————————————— 1 M. Zanovello et al., Unexpected frequency of the pathogenic ARCAG repeat 2 expansion in the general population. Brain, 2023 Jul 3;146(7):2723-2729.
ATXI FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results Demonstrating Substantial Increases in Complete Response Rates in Advanced Cutaneous Squamous Cell CarcinomaCheckpoint Therapeutics, Inc 55% objective response rate; 23% complete response rate in locally advanced cSCC 50% objective response rate; 13% complete response rate in metastatic cSCC Cosibelimab continues to demonstrate a favorable safety profile Biologics License Application currently under r...
Checkpoint Therapeutics, Inc 55% objective response rate; 23% complete response rate in locally advanced cSCC 50% objective response rate; 13% complete response rate in metastatic cSCC Cosibelimab continues to demonstrate a favorable safety profile Biologics License Application currently under review by U.S. FDA; PDUFA goal date of January 3, 2024 WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”). These results demonstrate a deepening of response over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Results determined by independent central review by treatment group were as follows: Parametera Locally Advanced cSCC (n=31) Metastatic cSCC (n=78) Data cutoff Mar 2022 Jan 2023 Nov 2021 Jan 2023 Objective response rate (95% confidence interval) 55% (36%, 73%) 55% (36%, 73%) 47% (36%, 59%) 50% (39%, 62%) Complete response rate 10 % 23 % 8 % 13 % Partial response rate 45 % 32 % 39 % 37 % Response ongoing 82 % 82 % 73 % 69 % Median duration of response Not reached Not reached Not reached Not reached a As assessed by independent central review. “We are excited to see the substantial increases in the rate of patients experiencing a complete response of their cSCC tumors with further cosibelimab treatment in both our locally advanced and metastatic pivotal trials,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We believe cosibelimab’s strong efficacy and response durability are driven by its unique two-fold mechanism of action in which cosibelimab binds to PD-L1 with sustained high target tumor occupancy to reactivate the body’s T-cell anti-tumor response, with the addition of a functional Fc domain to activate the body’s natural killer immune cells to induce antibody-dependent cell-mediated cytotoxicity of tumor cells, resulting in a powerful one-two punch to eradicate tumors. We expect this dual mechanism of action to benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive conditions or taking immunosuppressive medications who continue to suffer poor outcomes with currently available treatments.” Updated safety data across 247 patients enrolled and treated with cosibelimab in all cohorts of the ongoing study remain consistent with those previously reported, with only 2% of patients experiencing a severe immune-related adverse event (“irAE”) and less than 1% of patients discontinuing treatment due to an irAE of any severity, both substantially lower than the rates observed with currently approved immunotherapies. Mr. Oliviero continued, “Unlike PD-1 inhibitors, cosibelimab does not interrupt the body’s PD-1/PD-L2 pathway, which we believe results in cosibelimab’s low rates of autoimmunity. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients, such as those with solid organ transplants or autoimmune disease, upon its potential launch early next year. If our Biologics License Application (“BLA”) is approved in the coming months, based on its unique mechanism of action and compelling efficacy and safety profile, we believe cosibelimab, as a differentiated and possibly best-in-class treatment, has the potential to become the market leading immunotherapy for patients with cSCC, which we estimate to be a $1.6 billion annual U.S. market opportunity.” In January 2023, Checkpoint submitted a BLA to the U.S. Food and Drug Administration (“FDA”) seeking approval of cosibelimab as a treatment for patients with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or radiation. The application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. Checkpoint plans to present these updated results at an upcoming medical conference. About Checkpoint Therapeutics Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing open-label, multi-regional, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including cohorts in metastatic and locally advanced cutaneous squamous cell carcinoma (“cSCC”) intended to support one or more applications for marketing approval. Based on positive topline and interim results in metastatic and locally advanced cSCC, respectively, Checkpoint submitted a Biologics License Application (“BLA”) for these indications in January 2023, which application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com. Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the FDA review of the BLA for the approval of cosibelimab for the treatment of patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation and the commercial potential of cosibelimab if the BLA is approved, statements relating to the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, the two-fold mechanism of action of cosibelimab translating into potential enhanced efficacy, and our projections of publication and regulatory review timelines. Factors that could cause our actual results to differ materially include the following: the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company Contact: Jaclyn Jaffe Checkpoint Therapeutics, Inc. (781) 652-4500 ir@checkpointtx.com Investor Relations Contact: Ashley R. Robinson Managing Director, LifeSci Advisors, LLC (617) 430-7577 arr@lifesciadvisors.com Media Relations Contact: Katie Kennedy Gregory FCA 610-731-1045 checkpoint@gregoryfca.com
CKPT FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Avenue Therapeutics Announces Agreement with the FDA on the Study Design and Analysis Approach of the Phase 3 Safety Study for IV TramadolAvenue Therapeutics MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has r...
Avenue Therapeutics MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (“FDA”) on key elements of the Phase 3 safety study, including the primary endpoint and statistical analysis approach, for intravenous (IV) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine. The study will randomize post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in a Phase 3 efficacy trial. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. The primary endpoint is a composite of elements indicative of respiratory depression. "Based on IV tramadol's innovative mixed modality mechanism of action (agonism at the opioid mu receptor and reuptake inhibitor of serotonin and norepinephrine), decades of clinical experience in Europe and around the world, as well as the program’s positive data in two Phase 3 trials, we believe that IV tramadol will prove to be safe and effective in this final study and patient population," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “With over 100 million acute pain cases in the U.S. reported annually, patients and physicians seek an alternative pain management option with the potential to reduce the use of conventional opioids and the associated abuse potential in the post-operative setting, while effectively managing patient’s pain. We are confident that IV tramadol has the potential to overcome limitations of existing therapies and make a meaningful difference in the U.S. pain treatment landscape.” Avenue is submitting the revised protocol to the FDA including the statistical plan, which reflects the now agreed upon study design, for final review. "Our goal is to initiate the Phase 3 safety study this year, subject to obtaining the necessary financing which could be provided through a strategic partnership, and we expect that a positive study outcome could result in the FDA approval of IV tramadol. Additionally, we plan to provide updates on Avenue’s two earlier-stage clinical programs in the coming weeks, including our lead product candidate, AJ201 to treat spinal and bulbar muscular atrophy, and BAER101 for epilepsy. We remain committed to Avenue’s mission of delivering impactful therapies to treat patients with neurologic diseases, while building shareholder value,” said Dr. MacLean. About Avenue Therapeutics Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER101, an oral small molecule selective GABA-A α2/3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute postoperative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com. Forward-Looking Statements This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: expectations for increases or decreases in expenses; expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidate or any other products we may acquire or in-license; our use of clinical research centers and other contractors; expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities; expectations for generating revenue or becoming profitable on a sustained basis; expectations or ability to enter into marketing and other partnership agreements; expectations or ability to enter into product acquisition and in-licensing transactions; expectations or ability to build our own commercial infrastructure to manufacture, market and sell our product candidates; acceptance of our products by doctors, patients or payors; our ability to compete against other companies and research institutions; our ability to secure adequate protection for our intellectual property; our ability to attract and retain key personnel; availability of reimbursement for our products; estimates of the sufficiency of our existing cash and cash equivalents and investments to finance our operating requirements, including expectations regarding the value and liquidity of our investments; the volatility of our stock price; expected losses; expectations for future capital requirements; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn Jaffe Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com
ATXI FBIO FBIOP | finance.yahoo | about 2 years ago | Neutral

Quarterly Yearly

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

Free Stocks

Company

Features

Contact Us