Crispr Therapeutics shares tumble after significant earnings miss
Investing.com -- VYNE Therapeutics (NASDAQ:VYNE) stock fell 70% on Wednesday after the company announced its Phase 2b trial for repibresib gel in nonsegmental vitiligo failed to meet its primary and key secondary endpoints.
The clinical-stage biopharmaceutical company reported that the trial did not achieve the primary endpoint of F-VASI50 (the proportion of subjects achieving at least 50% improvement in Facial Vitiligo Area Scoring Index) at week 24 compared to vehicle. The trial also missed a key secondary endpoint of F-VASI75.
The company did note that nominally statistically significant effects were observed in some secondary and exploratory endpoints for the highest dose (3% concentration), including percent change from baseline in F-VASI score at week 24 compared to vehicle (-43.6% vs. -25.6%) and in T-VASI score (-28.3% vs. -16.2%).
VYNE attributed the disappointing results to an "unusually high vehicle effect" and a higher-than-expected dropout rate in the active treatment arms (36.6% for the 3% concentration) compared to the vehicle arm (10.6%).
"We are disappointed with the results of our Phase 2b trial, which were impacted by an unexpectedly high treatment effect in the vehicle arm and a high discontinuation rate in the active arms," said David Domzalski, President and Chief Executive Officer of VYNE.
Following these results, the company announced it will terminate the extension phase of the trial and seek an external partner for continued development of repibresib.
The trial evaluated 177 subjects across 45 sites in North America, testing three different concentrations (1%, 2%, and 3%) of repibresib gel against a vehicle control. Safety data showed a higher rate of treatment emergent adverse events in the treatment groups compared to vehicle, with application site pain being the most common side effect.
VYNE reported it had approximately $39.6 million in cash, cash equivalents, and investments as of June 30, 2025.
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