Hemab Therapeutics (COAG) FDA Approvals $38.45 -1.06 (-2.68%) As of 09:39 AM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsHeadlinesInsider TradesSEC FilingsShort InterestTrendsBuy This Stock Hemab Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Hemab Therapeutics (COAG). Over the past two years, Hemab Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as HMB-002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. HMB-002 FDA Regulatory Events HMB-002 is a drug developed by Hemab Therapeutics for the following indication: in Von Willebrand disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Data Presentation - July 14,2026Data Presentation Drug: HMB-002Announced Date: July 14, 2026Indication: in Von Willebrand diseaseAnnouncementHemab Therapeutics today presented clinical and preclinical data from sutacimig in GT and FVIID at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris, France. This follows the presentation of new clinical data from HMB-002 in Von Willebrand disease and the announcement of the HMB-003 program on Sunday, July 12.AI SummaryHemab Therapeutics presented new clinical and preclinical data on sutacimig at the ISTH 2026 Congress in Paris. In people with Glanzmann thrombasthenia (GT), Phase 2 long-term extension results showed that sutacimig continued to reduce bleeding over time, with safety and tolerability that were manageable. The company said it plans to start a Phase 3 trial in the second half of 2026 using an agreed weekly dosing schedule. Preclinical findings also showed sutacimig restored thrombin generation in Factor VII deficiency, even under disease-like conditions, supporting its possible use as a broad hemostatic treatment. In separate GT natural history studies, researchers confirmed that bleeding can be a lifelong burden and that preventive therapy is still underused, highlighting the need for better prophylaxis. The congress featured nine Hemab presentations in total, including data on HMB-002 and the HMB-003 program.Read Announcement Hemab Therapeutics FDA Events - Frequently Asked Questions Has Hemab Therapeutics received FDA approval? As of now, Hemab Therapeutics (COAG) has not received any FDA approvals for its therapy in the last two years. What drugs has Hemab Therapeutics submitted to the FDA? In the past two years, Hemab Therapeutics (COAG) has reported FDA regulatory activity for HMB-002. What is the most recent FDA event for Hemab Therapeutics? The most recent FDA-related event for Hemab Therapeutics occurred on July 14, 2026, involving HMB-002. The update was categorized as "Data Presentation," with the company reporting: "Hemab Therapeutics today presented clinical and preclinical data from sutacimig in GT and FVIID at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris, France. This follows the presentation of new clinical data from HMB-002 in Von Willebrand disease and the announcement of the HMB-003 program on Sunday, July 12." What conditions do Hemab Therapeutics' current drugs treat? Currently, Hemab Therapeutics has one therapy (HMB-002) targeting the following condition: in Von Willebrand disease. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Acurx Pharmaceuticals FDA EventsAtea Pharmaceuticals FDA EventsHemab Therapeutics FDA EventsIronwood Pharmaceuticals FDA EventsKura Oncology FDA EventsAvidity Biosciences FDA EventsSpero Therapeutics FDA EventsAgilent Technologies FDA EventsAligos Therapeutics FDA EventsANI Pharmaceuticals FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsBioMarin Pharmaceutical FDA EventsEnlivex Therapeutics FDA EventsErasca FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies PTC Therapeutics FDA Events Lantheus FDA Events Scholar Rock FDA Events Xenon Pharmaceuticals FDA Events Cogent Biosciences FDA Events Centessa Pharmaceuticals FDA Events Belite Bio FDA Events Erasca FDA Events Travere Therapeutics FDA Events Oruka Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:COAG last updated on 7/14/2026 by MarketBeat.com Staff. 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Data Presentation - July 14,2026Data Presentation Drug: HMB-002Announced Date: July 14, 2026Indication: in Von Willebrand diseaseAnnouncementHemab Therapeutics today presented clinical and preclinical data from sutacimig in GT and FVIID at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris, France. This follows the presentation of new clinical data from HMB-002 in Von Willebrand disease and the announcement of the HMB-003 program on Sunday, July 12.AI SummaryHemab Therapeutics presented new clinical and preclinical data on sutacimig at the ISTH 2026 Congress in Paris. In people with Glanzmann thrombasthenia (GT), Phase 2 long-term extension results showed that sutacimig continued to reduce bleeding over time, with safety and tolerability that were manageable. The company said it plans to start a Phase 3 trial in the second half of 2026 using an agreed weekly dosing schedule. Preclinical findings also showed sutacimig restored thrombin generation in Factor VII deficiency, even under disease-like conditions, supporting its possible use as a broad hemostatic treatment. In separate GT natural history studies, researchers confirmed that bleeding can be a lifelong burden and that preventive therapy is still underused, highlighting the need for better prophylaxis. The congress featured nine Hemab presentations in total, including data on HMB-002 and the HMB-003 program.Read Announcement
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