Rosnilimab shows promise in rheumatoid arthritis trial

Published 12/02/2025, 13:36

SAN DIEGO - AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company currently trading near its 52-week low at $12.38, announced significant findings from their Phase 2b RENOIR trial for rosnilimab, a potential new treatment for moderate-to-severe rheumatoid arthritis (RA). The trial met its primary endpoint at Week 12, showing a mean change from baseline in DAS-28 CRP for all rosnilimab doses compared to placebo. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 10.23, though it’s currently not profitable.

The study enrolled 424 patients across the U.S., Canada, and Europe, assessing the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of rosnilimab. Participants were either naïve to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) or had previous experience with such treatments. With a market capitalization of $376.55 million and significant cash reserves exceeding its debt obligations, AnaptysBio appears positioned to support its clinical development programs. Discover more detailed financial insights and 12 additional ProTips with InvestingPro.

Rosnilimab achieved statistical significance on key secondary endpoints at Week 12, including ACR20, ACR50, and CDAI LDA (low disease activity). At Week 14, 69% of patients treated with rosnilimab achieved CDAI LDA, with sustained and potentially deepening responses observed up to Week 28. The treatment also demonstrated robust pharmacological activity, including a significant reduction in PD-1high T cells and an increase in total Tregs, leading to a reduction in CRP levels, an objective measure of inflammation.

The safety profile of rosnilimab was comparable to placebo, with similar rates of adverse events (AEs) reported. No significant safety concerns, such as malignancies or major adverse cardiovascular events (MACE), were noted.

AnaptysBio plans to present full six-month data and additional translational data in Q2 2025, which is expected to further substantiate rosnilimab’s impact on immune homeostasis in RA. Additionally, top-line Week 12 Phase 2 data for rosnilimab in ulcerative colitis is anticipated in Q4 2025.

These results are based on a press release statement from AnaptysBio, Inc. and provide a promising outlook for rosnilimab as a potential new treatment option for RA patients. The company aims to address the unmet need for innovative therapies that offer long-term relief and disease modification. With the next earnings report due on February 27, 2025, and two analysts recently revising their earnings estimates upward, investors can track the company’s progress through comprehensive financial analysis available on InvestingPro.

In other recent news, AnaptysBio has been the subject of various analysts’ reports. H.C. Wainwright maintained a neutral rating on AnaptysBio, following its recent licensing agreement with Vanda Pharmaceuticals (NASDAQ:VNDA) for the commercialization of imsidolimab, a treatment for Generalized Pustular Psoriasis. The agreement involves a $15 million payment to AnaptysBio from Vanda.

Meanwhile, Truist Securities has reduced AnaptysBio’s stock price target from $30 to $20, maintaining a hold rating. This adjustment was due to the company’s recent Phase 2b trial failure of ANB032 in atopic dermatitis. Guggenheim also adjusted its outlook on AnaptysBio, reducing the stock’s price target to $36 from $90, but keeping a buy rating. This followed the company’s announcement of the failure of ANB032 in a Phase IIb atopic dermatitis study.

In addition, TD Cowen and Piper Sandler have highlighted key biotech catalysts for 2025. AnaptysBio is expected to release Phase II rheumatoid arthritis data for Rosnilimab in February 2025, according to TD Cowen. Piper Sandler has also identified AnaptysBio as one of the companies with key Phase 2b readouts expected in 2025. These recent developments reflect the ongoing analysis and expectations of analysts regarding AnaptysBio’s performance and future prospects.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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