AgomAb Therapeutics (AGMB) FDA Approvals $8.56 -0.09 (-1.04%) Closing price 10/2/2026 04:00 PM EasternExtended Trading$8.70 +0.15 (+1.69%) As of 10/2/2026 07:51 PM 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 ForecastsChartCompetitorsEarningsFDA EventsFinancialsNews and TrendsSEC FilingsShort Interest 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. Positive Results - October 1,2026Positive Results Drug: OntunisertibAnnounced Date: October 1, 2026Indication: Fibrostenosing Crohn’s DiseaseAnnouncementAgomab Therapeutics NV announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD, a severe manifestation of Crohn's disease characterized by progressive bowel fibrosis and intestinal strictures.Read AnnouncementProvided 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 October 1, 2026, involving Ontunisertib. The update was categorized as "Positive Results," with the company reporting: "Agomab Therapeutics NV announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD, a severe manifestation of Crohn's disease characterized by progressive bowel fibrosis and intestinal strictures." What conditions do AgomAb Therapeutics' current drugs treat? Currently, AgomAb Therapeutics has one therapy (Ontunisertib) targeting the following condition: Fibrostenosing Crohn’s 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 Agenus FDA EventsInflaRx FDA EventsCentury Therapeutics FDA EventsObsidian Therapeutics FDA EventsSurrozen FDA EventsVera Therapeutics FDA EventsVerastem FDA EventsJohnson & Johnson FDA EventsTeva Pharmaceutical Industries FDA EventsAktis Oncology FDA EventsAgomAb Therapeutics FDA EventsArtiva Biotherapeutics FDA EventsArvinas FDA EventsBioCardia FDA EventsCandel Therapeutics 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 Immunocore FDA Events Inhibrx Biosciences FDA Events Taysha Gene Therapies FDA Events Forte Biosciences FDA Events AnaptysBio FDA Events Syndax Pharmaceuticals FDA Events Ascentage Pharma Group International FDA Events Bicara Therapeutics FDA Events Ultragenyx Pharmaceutical FDA Events Damora Therapeutics, Inc. Common Stock FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:AGMB last updated on 10/1/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersThe $15 Gold Fund That Pays Up to $1,152/MonthGold is hitting record highs, but most investors are leaving income on the table. 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Positive Results - October 1,2026Positive Results Drug: OntunisertibAnnounced Date: October 1, 2026Indication: Fibrostenosing Crohn’s DiseaseAnnouncementAgomab Therapeutics NV announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD, a severe manifestation of Crohn's disease characterized by progressive bowel fibrosis and intestinal strictures.Read Announcement
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
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