AgomAb Therapeutics (AGMB) FDA Approvals $13.52 +0.65 (+5.05%) Closing price 04:00 PM EasternExtended Trading$13.45 -0.07 (-0.52%) As of 04:10 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 ForecastsChartCompetitorsFDA EventsFinancialsHeadlinesSEC 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. 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 EventsAkebia Therapeutics FDA EventsAltimmune FDA EventsEstrella Immunopharma FDA EventsNiagen Bioscience FDA EventsOmeros FDA EventsOSR FDA EventsRocket Pharmaceuticals FDA EventsTonix Pharmaceuticals FDA EventsZai Lab FDA EventsEli Lilly and Company FDA EventsClearPoint Neuro FDA EventsMoleculin Biotech FDA EventsAprea Therapeutics FDA EventsCapricor 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 ANI Pharmaceuticals FDA Events Ascentage Pharma Group International FDA Events Immunocore FDA Events Zymeworks FDA Events Sarepta Therapeutics FDA Events AbCellera Biologics FDA Events Recursion Pharmaceuticals FDA Events Taysha Gene Therapies FDA Events Maze Therapeutics FDA Events AnaptysBio FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:AGMB last updated on 6/24/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersALERT: Drop these 5 stocks before the market opens tomorrow!The Wall Street Journal is already raising the alarm about a potential market crash, and Weiss Ratings researc...Weiss Ratings | SponsoredLouis Navellier: My #1 AI stock for 2026 (name & ticker inside)Louis Navellier's Stock Grader system helped him flag Nvidia before its 82,000% run and has identified the top...InvestorPlace | SponsoredTrump Takes Emergency Action - Plus Elon Musk's New VentureElon Musk has quietly launched a new venture - one that has nothing to do with rockets, EVs, or Neuralink. Tru...Altimetry | SponsoredReady to give options a try? Your first trade (Ticker included) -INSIDETired of trying tactic after tactic when it comes to options trades... only to be met with market noise and st...Base Camp Trading | SponsoredTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredMy top 3 AI picks for the next decadeAlexander Green bought Apple in 1996, recommended Nvidia at a split-adjusted 66 cents in 2004, and picked up A...The Oxford Club | SponsoredThree oil giants buried the same discovery for 50 yearsIn 1976, Chevron tapped an energy source with no fuel costs, no carbon, and no supply chain - then killed the ...Behind the Markets | SponsoredWhere to Put $100 Before Trump's New Tech Law Rolls OutThe Financial Times says a new tech law puts America 'on the verge of a financial revolution.' Yahoo Finance e...Brownstone Research | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding AgomAb Therapeutics NV Please log in to your account or sign up in order to add this asset to your watchlist. Share AgomAb Therapeutics With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
