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Investing.com -- AnaptysBio Inc. (NASDAQ:ANAB) stock fell 20% after the clinical-stage biotechnology company announced it is discontinuing its ulcerative colitis trial due to rosnilimab failing to meet primary and key secondary endpoints.
The company reported that while rosnilimab was safe and well-tolerated with similar adverse event rates compared to placebo, it did not demonstrate adequate efficacy at Week 12 in the global Phase 2 trial for moderate-to-severe ulcerative colitis. The drug failed to meet the primary endpoint of mean change from baseline in modified Mayo Score as well as key secondary endpoints of clinical response and clinical remission.
Despite showing expected pharmacology, including approximately 90% depletion of pathogenic T cells, the efficacy results did not support further development in ulcerative colitis. The company noted that discontinuing the trial will result in at least $10 million in savings.
"Rosnilimab was safe and well tolerated, but we are disappointed in the lack of adequate efficacy and will discontinue the UC trial. However, we remain excited about the potential advancement of rosnilimab in RA and will provide an update in H1 2026 including funding by strategic or other sources of capital without diluting our royalties," said Daniel Faga, president and chief executive officer of Anaptys.
The Phase 2 study enrolled 136 moderate-to-severe patients across the U.S. and Europe. Clinical remission was achieved by only 7% of patients receiving rosnilimab at either dose level, compared to placebo. Even preliminary data showing increased remission rates between Week 12 and Week 24 did not meet the company’s six-month target product profile.
AnaptysBio reiterated its commitment to separate its biopharma operations from royalty assets in 2026 and anticipates ending 2025 with approximately $300 million, including an expected $75 million commercial sales milestone from GSK in the fourth quarter of 2025.
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