等待開盤 01-29 09:30:00 美东时间
-0.080
-2.31%
Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress") and its majority-owned subsidiary, Cyprium Therapeutics, Inc. ("Cyprium"), today announced that the U.S. Food and Drug Administration ("FDA") has approved ZYCUBO®
01-13 20:51
Fortress Biotech and Cyprium Therapeutics announced the FDA approval of ZYCUBO (copper histidinate) for Menkes disease, the first FDA-approved treatment for this rare pediatric condition. Sentynl Therapeutics assumed responsibility for ZYCUBO’s development and commercialization, transferring a Rare Pediatric Disease Priority Review Voucher (PRV) to Cyprium and offering up to $129 million in milestones. ZYCUBO significantly improves survival in Me...
01-13 12:45
Fortress Biotech ( ($FBIO) ) has shared an announcement. On December 12, 2025, ...
2025-12-16 06:45
Fortress Biotech and its subsidiary Cyprium Therapeutics announced the FDA has accepted the resubmission of the NDA for CUTX-101 to treat Menkes disease in pediatric patients. The new PDUFA target action date is January 14, 2026. Sentynl Therapeutics, a wholly-owned subsidiary of Zydus Group, assumed full responsibility for development and commercialization of CUTX-101 in December 2023. The FDA's complete response letter cited manufacturing site ...
2025-12-15 13:00
Fortress Biotech (NASDAQ:FBIO) reported quarterly earnings of $0.11 per share which beat the analyst consensus estimate of $(0.42) by 126.19 percent. This is a 114.47 percent increase over losses of $(0.76) per share
2025-11-14 21:43
Fortress Biotech (FBIO) is scheduled to announce Q3 earnings results on Wednesday, November 12th, after market close. The consensus EPS Estimate is -$0.63 and the consensus Revenue Estimate is $21.02M...
2025-11-12 06:35
Avenue Therapeutics and its subsidiary Baergic Bio have agreed to be acquired by Axsome Therapeutics for up to $82 million in potential milestones and royalties. The acquisition includes global rights to BAER-101, a novel epilepsy treatment, now to be known as AXS-17. Avenue expects to receive approximately 74% of future payments and royalties under the agreement. Baergic shareholders are eligible for up to $79 million in sales-based milestones a...
2025-11-06 12:00
Journey Medical Corporation will release its third quarter 2025 financial results after U.S. markets close on November 12, 2025. A conference call and audio webcast will be held on the same day at 4:30 p.m. ET. Interested parties can dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international) to join, or access the webcast via the company’s website. A replay will be available for 30 days. The company focuses on selling and marketing FDA-appr...
2025-11-05 13:30
Urica Therapeutics subsidiary Crystalys Therapeutics initiated Phase 3 trials (RUBY and TOPAZ) for dotinurad, a once daily URAT1 inhibitor for gout. The trials will assess safety and efficacy in 500 and 250 patients, respectively, with gout. Fortress Biotech's Lindsay Rosenwald highlighted the potential for advancing dotinurad in the U.S. and Europe. Urica holds a minority stake in Crystalys and is entitled to a 3% royalty on dotinurad sales. The...
2025-10-21 12:30
Fortress Biotech (NASDAQ:FBIO) fell ~31% in the premarket on Wednesday after the U.S. Food and Drug Administration (FDA) declined to approve CUTX-101, a treatment developed by the company and its Indi...
2025-10-01 20:59