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Fortress Biotech Reports First Quarter 2023 Financial Results and Recent Corporate Highlights
Fortress is advancing several late-stage clinical assets with two NDA submissions anticipated in second half of 2023 PDUFA goal date of January 3, 2024 set by
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Fortress is advancing several late-stage clinical assets with two NDA submissions anticipated in second half of 2023 PDUFA goal date of January 3, 2024 set by FDA for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, May 15, 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 financial results and recent corporate highlights for the first quarter ended March 31, 2023. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Fortress and our subsidiaries and partner companies continued advancing our promising clinical-stage drug candidates for a wide range of diseases during the first quarter of 2023. We expect data updates from multiple clinical programs in the coming months, including Phase 3 topline results for DFD-29 to treat papulopustular rosacea (“PPR”) in June of 2023. We also expect to report dose escalation and response data for MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHL”) and chronic lymphocytic leukemia (“CLL”), throughout the year. Dotinurad for the treatment of gout and Triplex for the treatment of cytomegalovirus continue to advance in clinical trials and we anticipate a dotinurad Phase 1 topline data readout in U.S. healthy volunteers in the second quarter of this year.” Dr. Rosenwald continued, “On the regulatory front, we expect the rolling New Drug Application (“NDA”) submission for CUTX-101 to treat Menkes disease to be complete by the end of 2023. We also anticipate filing an NDA for DFD-29 in the second half of 2023 and look forward to the January 3, 2024, Prescription Drug User Fee Act (“PDUFA”) goal date for cosibelimab to treat patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”). Overall, it is an exciting time for Fortress as we advance potential treatments for patients in need while focusing on increasing shareholder value.” Recent Corporate Highlights1: Cosibelimab (Anti PD-L1 antibody) Our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) (“Checkpoint”), submitted a Biologics License A...