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Agomab Reports Positive Results in FSCD Trial
Agomab announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with Fibrostenosing Crohn's disease or FSCD, a severe manifestation of Crohn's disease characterized by progressive bowel fibrosis and intestinal strictures. The OLE study evaluated long-term treatment with ontunisertib 200 mg BID on top of standard of care. The results demonstrated a generally favorable long-term safety and tolerability profile of ontunisertib 200 mg BID for up to 60 weeks of treatment, as well as maintenance of the gut-restricted pharmacokinetic profile observed in Part A of the trial. Sustained disease control, with low symptoms and disease activity scores and radiological stricture stabilization, was also observed. Importantly, a low FSCD-related annualized event rate of 3% was reported in patients treated with ontunisertib 200 mg BID up to 60 weeks. Agomab recently completed regulatory filings for NOV-ERA, a global Phase 2b trial designed to evaluate ontunisertib in approximately 320 patients with symptomatic FSCD and plans to initiate the study in the coming months. Agomab intends to present detailed STENOVA OLE results at a future scientific conference. Ontunisertib is an investigational drug and not approved by any regulatory authority.
Agomab Therapeutics NV Trading Halted Due to Volatility Trading Pause
Agomab Therapeutics NV trading halted, volatility trading pause
Agomab Initiates Phase 2b NOV-ERA Study for FSCD Treatment
Agomab announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal-restricted small molecule inhibitor of ALK5 for the potential treatment of Fibrostenosing Crohn's Disease, or FSCD. The company has aligned with the FDA on the study design of NOV-ERA, including the study's primary efficacy endpoint of endoscopic passability at Week 24 as assessed by the SES-CD narrowing score, as well as several secondary efficacy endpoints relevant to patients with FSCD. The protocol has been submitted to the FDA and has cleared central Institutional Review Board approval in the U.S. In addition, the study has received approval by Health Canada. The company has also submitted Clinical Trial Applications in multiple countries globally, including in the European Union and Asia Pacific territories. The company expects to initiate the NOV-ERA study following receipt of applicable regulatory and ethics approvals and plans to dose the first participants in the second half of 2026. The planned NOV-ERA study is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with symptomatic FSCD. The trial is expected to enroll up to 320 adult patients globally. To be eligible for the trial, participants must have at least one naive or anastomotic endoscopically non-passable ileal stricture, confirmed by a centrally read Simple Endoscopic Score for Crohn's Disease. Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels, or a matching placebo, administered twice daily. The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period.
Agomab Granted U.S. Patent for AGMB-447
Agomab announced that the United States Patent and Trademark Office, or USPTO, has granted U.S. Patent No. 12,577,230, covering the composition of matter of AGMB-447, to Agomab. AGMB-447 is the company's investigational inhaled lung-restricted small molecule inhibitor of ALK5, currently in a Phase 1b study for the treatment of Idiopathic Pulmonary Fibrosis. This patent provides intellectual property protection for AGMB-447 in the U.S. through at least 2041, excluding any potential patent term extensions.
Generate Biomedicines Debuts with 6% Price Increase
Generate Biomedicines made its public debut last week. The clinical‑stage company, which positions itself as a pioneer in AI‑driven drug design and development, enters the market with a pitch that its generative biology platform can accelerate and broaden therapeutic discovery.LATEST IPOS AND DIRECT LISTINGS:Generate Biomedicinesopened on February 27 at $15.00. The company priced 25M shares at $16.00. The deal priced at the midpoint of the $15.00-$17.00 target range. Generate Biomedicines is a clinical-stage generative biology company that says it is "pioneering the AI revolution in biotechnology and drug design and development."RECENT SPAC IPOS:Fortress Value Acquisition Vopened on February 26 at $10, after it priced its initial public offering of 25M Class A ordinary shares at a price of $10.00 per share.APEX Tech Acquisitionopened on February 26 at $9.98, after it priced its initial public offering of 10M units at an offering price of $10.00 per unit, with each unit consisting of one ordinary share and one right to receive one-fourth of one ordinary share upon the consummation of an initial business combination.MOZAYYX Acquisitionopened on February 25 at $9.96, after it priced its upsized initial public offering of 26.1M units at $10.00 per unit.ClearThink 1 Acquisitionopened on February 24 at $9.95, after it priced its initial public offering of 12.5M units at $10.00 per unit.PERFORMANCE:Price as of 11:00 am ET on Monday, March 2 -Generate Biomedicines – up over 6% at $13.48.RECENT IPOS TO WATCH:Forgent Power Solutions, Eikon Therapeutics, Bob's Discount Furniture, and Veradermicsare already seeing coverage roll out, while SpyGlass Pharma, Agomaband Once Upon A Farmare among stocks that could see new coverage this week as the quiet periods for banks that underwrote the companies' IPOs expire.UPCOMING IPOS:Upcoming IPO and direct listings expected include Liftoff, Cerebras Systems, ayPay, and OpenAI.Clickto see upcoming IPO calendar on TipRanks.Liftoff Mobile- The company announced that it has confidentially submitted a draft registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to the proposed initial public offering of its common stock. The total number of shares to be offered and the price range for the proposed offering have not yet been determined. The offering is subject to market and other conditions and the completion of the SEC's review process.Cerebras Systems– The company has filed confidentially for a U.S. initial public offering, The Information's Valida Pau and Katie Roof. The re-filing comes after a major sales pact with OpenAI, the authors note.PayPay Corporation- The company filed for an initial public offering of American depositary shares, or ADSs, and has applied to list the ADSs on the Nasdaq Global Select Market under the symbol "PAYP." The prospects filed with the SEC states, "As Japan's leading financial technology company, we are dedicated to our goal of becoming a digital finance platform for all... We launched this service in October 2018 and it rapidly expanded to become a nation-wide leading cashless payments ecosystem that had approximately 72 million PayPay registered users as of December 31, 2025, representing a penetration of 75% among 96 million smartphone users in Japan. With the acquisition of PayPay Card Corporation in October 2022, our platform evolved to a next-generation payments ecosystem, seamlessly integrating our code-based payment and credit card payment services through our PayPay app."OpenAI- The company is accelerating its plans for a public listing as rivalry with Anthropic intensifies, now planning on listing in Q4 of this year, Berber Jin, Corrie Driebusch, and Kate Clark of The Wall Street Journal. OpenAI is holding discussions with Wall Street banks about a potential initial public offering and has hired several executives to oversee its finance team, sources told the Journal.SpaceX- Elon Musk is targeting mid-June for the timing of SpaceX's initial public offering, IPO, Ivan Levingston, Stephen Morris, and Mercedes Ruehl of The Financial Times, citing five people familiar with the matter. The company is looking to raise $50B at a valuation of $1.5T, the sources added.Opening Day" is The Fly's recurring series of stories on the latest initial public offerings, their performance, and upcoming IPOs.
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