AgomAb Therapeutics (AGMB) FDA Approvals $11.94 +0.10 (+0.84%) Closing price 06/23/2026 04:00 PM EasternExtended Trading$12.18 +0.24 (+1.97%) As of 04:07 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsFDA EventsHeadlinesSEC FilingsShort InterestTrendsBuy This Stock AgomAb Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by AgomAb Therapeutics (AGMB). Over the past two years, AgomAb Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Ontunisertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Ontunisertib FDA Regulatory Events Ontunisertib is a drug developed by AgomAb Therapeutics for the following indication: Fibrostenosing Crohn’s 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. Provided Update - June 23,2026Provided Update Phase 2bDrug: OntunisertibAnnounced Date: June 23, 2026Indication: Fibrostenosing Crohn’s DiseaseAnnouncementAgomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-β RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD).AI SummaryAgomab Therapeutics NV has announced the design of its upcoming Phase 2b NOV-ERA study of ontunisertib, an investigational oral, GI-restricted inhibitor of ALK5 for the potential treatment of fibrostenosing Crohn’s disease (FSCD). The study is planned to test three doses of ontunisertib—400 mg, 200 mg, and 100 mg—against placebo in a 1:1:1:1 randomization, with twice-daily dosing. The trial will include a 6-week screening period, a 52-week treatment period, and a 2-week follow-up. Its main goal is to measure the proportion of patients who achieve endoscopic passability of the ileal index stricture at Week 24, a novel endpoint meant to help show whether the treatment can ease bowel narrowing. Agomab said the study is intended to help identify endpoints for later registrational trials. First patient dosing is expected in the second half of 2026, and the company notes that ontunisertib is still experimental and has not been proven safe or effective.Read Announcement AgomAb Therapeutics FDA Events - Frequently Asked Questions Has AgomAb Therapeutics received FDA approval? As of now, AgomAb Therapeutics (AGMB) has not received any FDA approvals for its therapy in the last two years. What drugs has AgomAb Therapeutics submitted to the FDA? In the past two years, AgomAb Therapeutics (AGMB) has reported FDA regulatory activity for Ontunisertib. What is the most recent FDA event for AgomAb Therapeutics? The most recent FDA-related event for AgomAb Therapeutics occurred on June 23, 2026, involving Ontunisertib. The update was categorized as "Provided Update," with the company reporting: "Agomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-β RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD)." What conditions do AgomAb Therapeutics' current drugs treat? Currently, AgomAb Therapeutics has one therapy (Ontunisertib) targeting the following condition: Fibrostenosing Crohn’s Disease. 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FDA EventsAgomAb Therapeutics FDA EventsAmylyx Pharmaceuticals FDA EventsCoherus Oncology FDA EventsDiaMedica Therapeutics FDA EventsEntera Bio FDA EventsGalectin Therapeutics FDA EventsGilead Sciences FDA EventsJaguar Animal Health FDA EventsKalaris Therapeutics FDA EventsMicrobot Medical FDA EventsPhathom Pharmaceuticals 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 Syndax Pharmaceuticals FDA Events Urogen Pharma FDA Events Compass Pathways FDA Events Capricor Therapeutics FDA Events Zymeworks FDA Events Recursion Pharmaceuticals FDA Events SELLAS Life Sciences Group FDA Events MoonLake Immunotherapeutics FDA Events Vir Biotechnology FDA Events Bicara Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:AGMB last updated on 6/24/2026 by MarketBeat.com Staff. 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Provided Update - June 23,2026Provided Update Phase 2bDrug: OntunisertibAnnounced Date: June 23, 2026Indication: Fibrostenosing Crohn’s DiseaseAnnouncementAgomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-β RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD).AI SummaryAgomab Therapeutics NV has announced the design of its upcoming Phase 2b NOV-ERA study of ontunisertib, an investigational oral, GI-restricted inhibitor of ALK5 for the potential treatment of fibrostenosing Crohn’s disease (FSCD). The study is planned to test three doses of ontunisertib—400 mg, 200 mg, and 100 mg—against placebo in a 1:1:1:1 randomization, with twice-daily dosing. The trial will include a 6-week screening period, a 52-week treatment period, and a 2-week follow-up. Its main goal is to measure the proportion of patients who achieve endoscopic passability of the ileal index stricture at Week 24, a novel endpoint meant to help show whether the treatment can ease bowel narrowing. Agomab said the study is intended to help identify endpoints for later registrational trials. First patient dosing is expected in the second half of 2026, and the company notes that ontunisertib is still experimental and has not been proven safe or effective.Read Announcement
