Fortress Biotech, Inc. (FBIO) News
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Latest FBIO News From Around the Web
Below are the latest news stories about FORTRESS BIOTECH INC that investors may wish to consider to help them evaluate FBIO as an investment opportunity.
FDA accepts Sentynl’s Menkes disease therapy NDA for priority reviewSentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics. |
Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes DiseaseSentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), and Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress") announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and Priority review Sentynl's New Drug Application (NDA) for CUTX-101, the product candidate for the treatment of Menkes disease. Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the c |
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes DiseasePriority 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, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the acceptance for |
Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT™ (cosibelimab-ipdl)UNLOXCYT is the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinomaWALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative r |
Fortress Biotech Third Quarter 2024 Earnings: Misses ExpectationsFortress Biotech ( NASDAQ:FBIO ) Third Quarter 2024 Results Key Financial Results Revenue: US$14.6m (down 7.1% from 3Q... |
Fortress Biotech: Q3 Earnings SnapshotBAY HARBOR ISLAND, Fla. AP) — Fortress Biotech Inc. FBIO) on Thursday reported a loss of $12.9 million in its third quarter. |
Fortress Biotech Reports Third Quarter 2024 Financial Results and Recent Corporate HighlightsEmrosi 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 long-term value for shareholders through product revenue, equity holdings |
Avenue Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights- Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024MIAMI, Nov. 14, 2024 (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 reported financial results and recent corporate highlights for the third quarter ended September 30, 2024. “We have gen |
Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate UpdatesBiologics License Application for cosibelimab under review by U.S. FDA PDUFA goal date of December 28, 2024 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2024, and recent corporate updates. “With the Prescription Drug User Fee Act (“PDUFA”) goal date set for next month, we await the decision by t |
Journey Medical Corporation Reports Third Quarter 2024 Financial Results and Recent Corporate HighlightsU.S. FDA approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the treatment of inflammatory lesions of rosacea in adults; launch expected in late Q1 or early Q2 of 2025 Total revenues for the third quarter ended September 30, 2024 were $14.6 million SCOTTSDALE, Ariz., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on the |