AnaptysBio has ended its global Phase 2 study of rosnilimab in moderate‑to‑severe ulcerative colitis after the 136‑patient trial failed to meet its primary endpoint of mean change in the modified Mayo Score and key secondary endpoints of clinical response and remission at week 12. The study compared 400 mg subcutaneous rosnilimab every four weeks and 800 mg every two weeks to placebo, and the data showed no superiority over placebo in any efficacy measure. Safety results were favorable, with no treatment‑related serious adverse events reported.
The company estimates that discontinuing the UC program will generate at least $10 million in cost savings and will free resources for its rheumatoid arthritis (RA) program and other assets such as ANB033. CEO Daniel Faga said the company is disappointed by the UC results but remains optimistic about rosnilimab’s potential in RA. The decision reflects a strategic shift toward focusing on wholly‑owned, differentiated antibody assets rather than maintaining a broader portfolio of out‑licensed programs.
AnaptysBio’s Q3 2025 financials provide context for the decision. Net income rose to $15.11 million, or $0.54 per share, beating consensus estimates of $0.17 by $0.37—a 219% upside. Revenue reached $76.32 million, a $60.49 million or 382% beat over the $15.83 million consensus. The surge was driven by $76.3 million in collaboration revenue from Jemperli sales, up from $30.0 million in Q3 2024, and by a robust cash position of $256.7 million as of September 30, 2025, with an expected ending cash balance of roughly $300 million for the year. These results give the company a runway through 2026 and support its ability to invest in high‑potential programs.
The RA program is a key focus moving forward. AnaptysBio announced positive Phase 2b data for rosnilimab in RA on October 29, 2025, and the U.S. RA market is estimated at $20 billion. The data suggest a favorable safety profile and JAK‑like efficacy, positioning rosnilimab as a potential new mechanism of action in a market that has seen few novel approvals since 2012. The company’s cash runway and the strong collaboration revenue provide the financial flexibility to pursue this indication.
Beyond RA, AnaptysBio is advancing other pipeline assets. ANB033, a CD122 antagonist, is in Phase 1b for celiac disease and will enter a second inflammatory disease Phase 1b in 2026. The company has also out‑licensed Jemperli to GSK and imsidolimab to Vanda Pharmaceuticals, and it plans to separate its biopharma operations from its royalty assets by the end of 2026 to unlock value for investors.
Investors reacted positively to the announcement, driven primarily by the Q3 2025 earnings beat and the promising RA data. The market’s favorable response indicates that the company’s strong financial performance and strategic focus on high‑potential assets outweigh the disappointment of the UC trial termination.
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