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SAN DIEGO - AnaptysBio, Inc. (NASDAQ: ANAB), a clinical-stage biotechnology company with a market capitalization of approximately $694 million, has announced positive results from a Phase 2b trial for its investigational drug, rosnilimab, aimed at treating moderate-to-severe rheumatoid arthritis (RA). The company’s stock has shown strong momentum, gaining over 8% in the past week. The trial, which included 424 patients, showed that rosnilimab could achieve low disease activity (LDA) and remission in RA patients with a favorable safety profile.
Rosnilimab demonstrated JAK-like efficacy over a six-month period, with the potential for monthly subcutaneous dosing. The drug was particularly noted for its tolerability when compared to standard of care biologics or JAK inhibitors. According to AnaptysBio, responses seen with rosnilimab were durable for at least two months after cessation of treatment, indicating the possibility of extended dosing intervals, such as every eight weeks, in a maintenance setting.
The trial’s primary endpoint was the mean change from baseline in Disease Activity Score 28-C Reactive Protein (DAS-28 CRP), with significant reductions observed at Week 12 versus placebo. By Week 28, a notable percentage of patients achieved clinical remission and LDA, with the highest response rates not yet observed due to strict continuation criteria.
In terms of safety, rosnilimab was well tolerated with no treatment-related serious adverse events (SAEs) reported. Adverse events (AEs) were primarily mild to moderate, and the discontinuation rate due to AEs was less than 2% across the entire trial.
The trial also highlighted rosnilimab’s impact on patient-reported outcomes, including significant improvements in the Pain Visual Analog Scale (VAS) and Health Assessment Questionnaire-Disability Index (HAQ-DI).
AnaptysBio’s president and CEO, Daniel Faga, expressed optimism about the drug’s potential in the approximately $20 billion U.S. RA market. The company is also conducting a Phase 2 study for rosnilimab in ulcerative colitis (UC), with initial data expected in Q4 2025. According to InvestingPro analysis, while the company maintains strong liquidity with a current ratio of 8.25, it faces profitability challenges with negative gross margins. Analyst price targets range widely from $18 to $90, reflecting diverse views on the company’s potential.
The information presented is based on a press release statement from AnaptysBio, Inc. and has not been independently verified. The safety and efficacy of rosnilimab have not yet been evaluated by regulatory authorities. For deeper insights into AnaptysBio’s financial health and 12 additional exclusive ProTips, visit InvestingPro, your source for comprehensive investment analysis and real-time market intelligence.
In other recent news, AnaptysBio has reported a solid financial position with over $420 million in cash and investments as of the end of 2024. The company has also authorized a stock repurchase plan worth up to $75 million, signaling confidence in its financial standing. AnaptysBio expects to receive a $75 million milestone payment from its collaboration with GSK, either in 2025 or 2026, which further strengthens its cash runway projected through the end of 2027. Guggenheim analysts have upgraded their price target for AnaptysBio to $90, maintaining a Buy rating, citing the company’s robust financials and undervalued stock. Wolfe Research also maintains an Outperform rating with a $25 target, noting the company’s potential growth and undervaluation. Meanwhile, H.C. Wainwright has kept a Neutral rating with a $22 target, focusing on the promising clinical trial data of rosnilimab, AnaptysBio’s treatment for rheumatoid arthritis. The company’s ongoing partnerships and strategic financial maneuvers, including the stock buyback plan, continue to bolster investor confidence.
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