H.C. Wainwright Downgrades VYNE Therapeutics to Neutral Following Vitiligo Trial Miss

H.C. Wainwright downgraded VYNE Therapeutics to Neutral from Buy and removed its $4.50 price target after the company's Phase 2b trial for repibresib in nonsegmental vitiligo failed to achieve its primary and secondary endpoints. The analyst described the result as a "surprise" and stated that the company's current risk profile "pushes us to the sidelines."

H.C. Wainwright, a prominent equity research firm, has downgraded VYNE Therapeutics to 'Neutral' from 'Buy' following the disappointing results of the company's Phase 2b clinical trial for repibresib gel in nonsegmental vitiligo. The trial missed both its primary and key secondary endpoints, leading to a significant setback for the biopharmaceutical company [1].

The trial, which enrolled 177 patients across 45 sites in North America, aimed to evaluate the once-daily topical administration of repibresib gel at 1%, 2%, and 3% concentrations compared to a vehicle control. The primary endpoint, defined as the proportion of patients achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24, was not met. Additionally, the trial missed a key secondary endpoint (F-VASI75) [1][2][3].

Despite the overall failure, the company highlighted that statistically significant effects 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 [1][2][3].

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 [1][2][3].

The company plans to end the trial’s extension phase and seek an external partner to support further development of repibresib. VYNE has approximately $39.6 million in cash, cash equivalents, and investments on hand as of June 30, 2025 [1][2][3].

Analyst Joseph Pantginis of H.C. Wainwright described the trial outcome as a "surprise" that "puts the company in a precarious position." The firm will remain on the sidelines pending further clarity on repibresib, additional VYN202 data, or potential new asset acquisitions [2].

Retail sentiment on Stocktwits was 'extremely bullish' late Wednesday amid an 11,800% surge in 24-hour message volume, with some users expressing optimism about the underlying science and VYNE's cash position [2].

VYNE's stock has declined 88.1% so far in 2025, reflecting the challenges faced by the company. Despite the setback, the company remains confident in the potential of its InhiBET BET inhibitor platform [2].

References:
[1] https://ih.advfn.com/market-news/article/13793/vyne-therapeutics-shares-plunge-70-after-vitiligo-trial-misses-key-goals
[2] https://stocktwits.com/news-articles/markets/equity/vyne-hit-with-downgrades-after-repibresib-misses-endpoints-in-vitiligo-trial-traders-still-eye-rebound/chohuEKR5Co
[3] https://www.investing.com/news/company-news/vynes-vitiligo-treatment-fails-primary-endpoint-in-phase-2b-trial-93CH-4160551