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BRIDGEWATER, N.J. - VYNE Therapeutics Inc. (NASDAQ:VYNE), a clinical-stage biotech company with a market capitalization of $6.45 million, announced Wednesday that its Phase 2b trial evaluating Repibresib gel for nonsegmental vitiligo failed to meet its primary endpoint and a key secondary endpoint. According to InvestingPro data, the company faces significant challenges with rapid cash burn and negative earnings expectations for the year.
The trial, which evaluated 177 subjects, did not achieve the targeted proportion of patients reaching a 50% improvement in Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to vehicle. It also missed the key secondary endpoint of F-VASI75.
Despite these setbacks, the company reported nominally statistically significant effects in the highest dose cohort (3%) for percent change from baseline in F-VASI score at week 24 (-43.6% vs. -25.6% for vehicle) and in Total Vitiligo Area Scoring Index (T-VASI) score (-28.3% vs. -16.2%).
VYNE attributed the disappointing results to an "unusually high vehicle effect" and higher-than-expected dropout rates in the active treatment arms (36.6% for 3% concentration) compared to vehicle (10.6%).
"We are disappointed with the results of our Phase 2b trial," said David Domzalski, President and CEO of VYNE. "Although we missed our F-VASI50 and F-VASI75 endpoints, we did see a meaningful reduction in the percent change from baseline in both F-VASI and T-VASI for our highest dose."
The company will terminate the extension phase of the trial and plans to seek an external development and commercialization partner for Repibresib.
Regarding safety, the most common treatment-emergent adverse events were cutaneous in nature, with application site pain being the most frequent (14.0% in the 3% concentration group versus 3.8% in the vehicle group). With revenue of just $0.6 million in the last twelve months and an EBITDA of -$45.44 million, the company’s financial performance reflects its development-stage status.
VYNE expects to report approximately $39.6 million in cash, cash equivalents and investments as of June 30, 2025, according to the press release statement. InvestingPro analysis shows the company maintains a strong current ratio of 4.47, with liquid assets exceeding short-term obligations. The stock currently trades near its 52-week low, with a year-to-date return of -57%. Get access to 8 more exclusive InvestingPro Tips to better understand VYNE’s financial health and market position.
In other recent news, VYNE Therapeutics reported that its Phase 2b trial for repibresib gel in nonsegmental vitiligo did not meet the primary and key secondary endpoints. The trial failed to achieve the primary endpoint of F-VASI50, a measure of improvement in the Facial Vitiligo Area Scoring Index, at week 24. Following this announcement, H.C. Wainwright downgraded VYNE Therapeutics from Buy to Neutral, citing the trial data as a reason. Despite this, the same firm reiterated its Buy rating on VYNE’s VYN202 program for moderate-to-severe plaque psoriasis after the FDA partially lifted a clinical hold. The FDA’s decision allows the resumption of the Phase 1b trial in female patients, although the higher 1 mg dose remains excluded. BTIG also reiterated its Buy rating on VYNE Therapeutics, expressing optimism about future data for repibresib as a potential first-line treatment for vitiligo. The firm anticipates topline data to support repibresib as a competitor to the currently approved therapy, Opzelura. These developments highlight the ongoing clinical evaluations and regulatory interactions for VYNE Therapeutics.
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