Shares of VYNE Therapeutics (NASDAQ:VYNE) plummeted 70% on Wednesday after the biopharmaceutical company revealed that its Phase 2b clinical trial for repibresib gel in nonsegmental vitiligo failed to meet both its primary and key secondary endpoints.
The trial did not achieve the F-VASI50 benchmark at week 24, which measures the proportion of patients achieving at least a 50% improvement in facial vitiligo using the Facial Vitiligo Area Scoring Index. It also missed the F-VASI75 secondary goal.
Despite the overall failure, the company highlighted that statistically significant effects—though nominal—were seen in certain secondary and exploratory outcomes at the highest tested dose (3%). This included a 43.6% improvement in F-VASI scores from baseline compared to 25.6% for the vehicle, and a 28.3% improvement in T-VASI versus 16.2% in the vehicle group.
VYNE attributed the underwhelming results to “an unusually high vehicle effect” and elevated dropout rates in the treatment arms. The 3% concentration group had a 36.6% dropout rate, much higher than the 10.6% seen in the control arm.
“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, VYNE’s President and Chief Executive Officer.
In response, the company said it would end the trial’s extension phase and seek an external partner to support further development of repibresib.
The study enrolled 177 patients across 45 sites in North America, testing 1%, 2%, and 3% concentrations of repibresib gel versus a vehicle control. Adverse events occurred more frequently in the treatment arms, with application site pain being the most reported issue.
As of June 30, 2025, VYNE reported having approximately $39.6 million in cash, cash equivalents, and investments on hand.
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