Emrosi™ approved by FDA for the treatment of inflammatory lesions of rosacea in adults, with commercial launch underway; initial distribution ongoing and first prescriptions filled Fortress subsidiary Checkpoint Therapeutics to be acquired by Sun Pharma; Checkpoint’s lead product, UNLOXCYT™, approved by FDA for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma FDA accepted New Drug Application... Read More

FRANKFURT, Germany and MIAMI, March 17, 2025 (GLOBE NEWSWIRE) -- Partex NV and Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company, today announced a strategic collaboration aimed at identifying and evaluating biopharmaceutical compounds using artificial intelligence (AI) for potential acquisition or licensing by Fortress. Partex will deploy its proprietary AI-based drug discovery and... Read More

Study is the first randomized, controlled trial examining a vaccine’s effectiveness in controlling CMV in recipients of HSCT from vaccinated donors Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO)... Read More

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary,... Read More

Six-month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for June 30, 2025 CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease, a rare and fatal pediatric disease SOLANA BEACH, Calif. and AHMEDABAD, India and MIAMI , Jan. 6, 2025 /PRNewswire/ -- Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus... Read More

Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc . (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance... Read More

MIAMI, Sept. 26, 2024 (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 that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the following... Read More

MIAMI, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), 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 that on September 19, 2024 it entered into securities purchase agreements with healthcare focused... Read More

MIAMI, Sept. 04, 2024 (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 that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate overview... Read More

PDUFA goal date of November 4, 2024 for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults FDA accepted Biologics License Application resubmission for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of December 28, 2024 MIAMI, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative... Read More

MIAMI, July 25, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”, or the “Company”), 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 that it has entered into a new loan agreement (the “Agreement”) for up to $50 million with funds... Read More

MIAMI, July 05, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO; FBIOP) (“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 that its Board of Directors has paused the payment of dividends on the Company’s 9.375% Series A Cumulative... Read More

MIAMI, May 16, 2024 (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 that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat... Read More

Fortress‘ late-stage pipeline continues to advance and may generate up to three regulatory approvals on NDAs and BLAs in the next 12 months and potentially a fourth BLA filing as early as 2025 FDA accepted New Drug Application filing for DFD-29 to treat inflammatory lesions and erythema of rosacea in adults; PDUFA goal date of November 4, 2024 MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO)... Read More

Helocyte, a majority-owned subsidiary of Fortress Biotech, is developing Triplex for the prevention and treatment of cytomegalovirus in multiple transplant indications, as well as HIV Clinical trial funded by a NIAID grant to a multi-center university consortium Study is evaluating whether Triplex is safe and effective in improving the outcomes of liver transplant recipients MIAMI, May 14, 2024 (GLOBE NEWSWIRE) -- Fortress... Read More

Record consolidated net revenue of $84.5 million for full-year 2023 Fortress may receive up to four regulatory decisions on NDAs and BLAs in the next 18 months FDA accepted New Drug Application filing for DFD-29 to treat inflammatory lesions and erythema of rosacea in adults; PDUFA goal date of November 4, 2024 MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative... Read More

MIAMI, March 12, 2024 (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 participate in a fireside chat at the 36 th Annual ROTH... Read More

Encouraging preclinical studies demonstrate potential to combine AAV-ATP7A gene therapy with CUTX-101, which could be the first FDA-approved treatment for Menkes disease Cyprium Therapeutics, a majority-owned subsidiary of Fortress Biotech, is developing AAV-ATP7A gene therapy to be used in conjunction with CUTX-101 for the treatment of Menkes disease MIAMI, March 04, 2024 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc.... Read More

MIAMI, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced the closing of its previously announced registered direct offering. The company issued 3,303,305 shares of its common stock and... Read More

MIAMI, Dec. 29, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that it has entered into a definitive agreement for the issuance and sale of 3,303,305 shares of its common stock and warrants to... Read More

Sentynl receives worldwide proprietary rights and U.S. FDA documents pertaining to CUTX-101 copper histidinate CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease; rolling submission of New Drug Application to FDA is ongoing and expected to be completed in 2024 SOLANA BEACH, Calif. and AHMEDABAD, India , Dec. 6, 2023 /PRNewswire/ -- Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based... Read More

Cyprium received $4.5 million payment upon closing and remains eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101 MIAMI, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary... Read More

Total consolidated net revenue was $34.8 million in the third quarter of 2023, a 100% increase from total consolidated net revenue of $17.4 million in the second quarter of 2023 Fortress is advancing several late-stage clinical assets with three potential NDA and BLA submissions to FDA through year-end of 2024 across our portfolio 1 , including a NDA submission for DFD-29 to treat rosacea, anticipated around year-end of 2023... Read More

MIAMI, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced the closing of its previously announced public offering of an aggregate of 5,885,000 units, consisting of one share of common stock... Read More

MIAMI, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced the pricing of its public offering of an aggregate of 5,885,000 units, at a public offering price of $1.70 per unit, consisting of... Read More

MIAMI, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that it has commenced a public offering, subject to market and other conditions, to offer and sell units, consisting of (i) one... Read More

Recent $11.3 million grant from the California Institute for Regenerative Medicine (CIRM) intended to fund the Phase 1 clinical trial at City of Hope; the Investigational New Drug application for which has now been accepted by the Food and Drug Administration In preclinical studies, administration of the dual-action CAR T cells followed by administration of a CMV vaccine successfully eradicated HIV, including from latent... Read More

MIAMI, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or the “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, announced that it will effect a 1-for-15 reverse stock split of its issued and outstanding common stock. Fortress expects its common stock to... Read More

MIAMI, Oct. 05, 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 ROTH MKM 2023... Read More

MIAMI, Sept. 07, 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 H.C. Wainwright 25th... Read More

Total net revenue was $17.4 million in the second quarter of 2023, a 40% increase from $12.4 million in the first quarter of 2023 Positive topline results from two Phase 3 clinical trials evaluating DFD-29 demonstrated achievement of co-primary and all secondary endpoints versus placebo and Oracea® (doxycycline) with no significant safety issues Fortress is advancing several late-stage clinical assets with two NDA... Read More

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... Read More

Data from Phase 1 clinical trial in healthy volunteers show comparable pharmacokinetic, pharmacodynamic and safety profile between U.S. and Japanese healthy subjects Initiating Phase 1b clinical trial in gout patients in the U.S. and expect to begin pivotal clinical trials in 2024 MIAMI, June 29, 2023 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”)... Read More

Multicenter randomized placebo-controlled trials will evaluate the ability of the cytomegalovirus (“CMV”) vaccine to enhance protective virus-specific immunity in stem cell donors to reduce the risk of CMV events in high-risk transplant recipients Encouraging pilot study results demonstrate the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic hematopoietic cell... Read More

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,... Read More

MIAMI, April 24, 2023 (GLOBE NEWSWIRE) -- Aevitas Therapeutics, Inc. (“Aevitas”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary company, and 4D Molecular Therapeutics (Nasdaq: FDMT) (“4DMT”), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large-market diseases, today announced the execution of an asset purchase agreement for 4DMT to... Read More

Fortress expects to file a total of three new drug applications in 2023 Record consolidated net revenue of $75.7 million for full-year 2022 FDA accepted for filing the Biologics License Application for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of January 3, 2024 Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is expected to be... Read More

MIAMI, March 07, 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 participate in two investor conferences in March 2023.... Read More

Results demonstrate the potential benefit of vaccinating donors with Triplex to enhance CMV protective immunity and reduce CMV events in recipients of allogeneic hematopoietic cell transplant Helocyte, Inc., a subsidiary company of Fortress Biotech, is developing Triplex for the treatment of CMV MIAMI, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc. , (“Helocyte”) a subsidiary company of Fortress Biotech, Inc. (Nasdaq:... Read More

Phase 2 clinical trial planned to evaluate efficacy of Triplex-vaccinated donors to enhance protective CMV-specific T cell immunity in stem cell transplant recipients Helocyte, Inc., a subsidiary company of Fortress Biotech, is developing Triplex for the treatment of CMV MIAMI, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc., (“Helocyte”) a subsidiary company of Fortress Biotech, Inc. (Nasdaq: FBIO), announced today that... Read More

MIAMI, Feb. 10, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced the closing of its previously announced registered direct offering and concurrent private placement. The Company issued 16.6 million... Read More

MIAMI, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress” or “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that it has entered into definitive agreements for the issuance and sale of 16.6 million shares of its common stock in a registered... Read More

MIAMI, Dec. 19, 2022 (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 Lucy Lu, M.D., has been appointed to its Board of Directors. Dr. Lu is an accomplished executive with over 20 years of experience in a wide... Read More

MIAMI, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”) (formerly known as UR-1 Therapeutics, Inc.), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary company focused on the development and commercialization of pharmaceutical products to treat gout and other conditions associated with hyperuricemia, today announced that the Company has expanded its exclusive license... Read More