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Fortress Biotech Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
Emrosi™ commercial launch initiated for the treatment of inflammatory lesions of rosacea in adults Fortress subsidiary Checkpoint Therapeutics to be acquired by Sun Pharma; special meeting of Checkpoint stockholders to approve the transaction to take place on May 28, 2025 FDA accepted New Drug Application filing for priority review of CUTX-101 to treat Menkes disease; PDUFA goal date of September 30, 2025 MIAMI, May 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”),
About this update from Journey Medical Corporation
Emrosi™ commercial launch initiated for the treatment of inflammatory lesions of rosacea in adults Fortress subsidiary Checkpoint Therapeutics to be acquired by Sun Pharma; special meeting of Checkpoint stockholders to approve the transaction to take place on May 28, 2025 FDA accepted New Drug Application filing for priority review of CUTX-101 to treat Menkes disease; PDUFA goal date of September 30, 2025 MIAMI, May 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2025. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Fortress entered 2025 with strong momentum following a transformational fourth quarter marked by the U.S. Food and Drug Administration (“FDA”) approvals of Emrosi™ and UNLOXCYT™, and the acceptance of the New Drug Application (“NDA”) for CUTX-101. In the first quarter 2025, our Fortress-founded partner company, Checkpoint Therapeutics, Inc., (“Checkpoint”), signed a merger agreement with Sun Pharma providing for Checkpoint’s acquisition by Sun Pharma, which we believe will enable broader patient access for Checkpoint’s UNLOXCYT (cosibelimab-ipdl) product and trigger a significant monetization event for Fortress — including an expected ~$28 million at closing, future potential royalties, and a potential CVR payment. These outcomes continue to validate Fortress’ business model — identifying, developing, and advancing innovative therapies with strategic optionality for value creation.” Dr. Rosenwald continued, “Looking ahead, we are focused on key value drivers, including the September 30, 2025 Prescription Drug User Fee Act (“PDUFA”) action date for CUTX-101, which may also result in a Priority Review Voucher for our subsidiary, Cyprium Therapeutics, upon approval. Commercial launch of Emrosi is also underway with initial prescriptions filled at the end of March. Fortress’ robust pipeline — including multiple late-stage programs and newly approved products — positions us for continued revenue growth, value-driving milestones, and additional monetization opportunities. We remain committed to delivering innovative therapies to patients while building long-term shareholder value.” Recent Corporate Highlights 1 : Monetization Updates Regulatory Updates Commercial Product Updates Clinical Updates General Corporate: Financial Results: About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has eight marketed prescription pharmaceutical products and over 20 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. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance 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, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com . Forward-Looking Statements Statements in this press release that are not descriptions of historical facts are “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. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These 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, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; uncertainty related to the timing and completion of the closing of the acquisition of Checkpoint by Sun Pharma and the failure to realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; 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 [email protected] Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 [email protected] _____________ 1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private or public subsidiaries (referred to herein as “subsidiaries” or “partner companies”) and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”). The words “we”, “us” and “our” may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.
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