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Investing.com - VYNE Therapeutics (NASDAQ:VYNE) has been downgraded from Buy to Neutral by BTIG following disappointing clinical trial results for its repibresib treatment. The stock, trading at $0.40, has experienced a dramatic 70% decline in the past week, according to InvestingPro data.
The downgrade comes after repibresib failed to meet both the primary endpoint (F-VASI50) and key secondary endpoint (F-VASI75) in its Phase 2b vitiligo trial. According to BTIG, management attributed these results to an unexpectedly high treatment effect in the vehicle arm combined with high discontinuation rates in active treatment arms. Despite the setback, InvestingPro data shows the company maintains a healthy current ratio of 4.47 and holds more cash than debt on its balance sheet.
VYNE has decided to discontinue treatment in the ongoing extension phase and terminate the trial entirely. The company did observe nominal statistically significant effects in some secondary and exploratory endpoints with the 3% concentration, which was the highest dose tested.
Management plans to analyze the full data set to determine next steps and intends to seek a development and commercialization partner for repibresib. The company will also provide an update on repibresib and VYN202, an oral BET inhibitor currently on partial clinical hold by the FDA, in the coming weeks.
BTIG analyst Julian Harrison indicated the firm would maintain a Neutral rating on VYNE stock while awaiting additional updates from management regarding the company’s strategic direction.
In other recent news, VYNE Therapeutics announced that its Phase 2b trial for Repibresib gel in nonsegmental vitiligo failed to meet both its primary and key secondary endpoints. The trial, which involved 177 subjects, did not achieve the targeted proportion of patients reaching a 50% improvement in the Facial Vitiligo Area Scoring Index at week 24, nor did it meet the key secondary endpoint. Following this announcement, H.C. Wainwright downgraded VYNE Therapeutics from Buy to Neutral, removing its previous price target due to the trial’s failure to meet expectations. Separately, VYNE provided an update on its VYN202 program for plaque psoriasis, where the FDA lifted a clinical hold on the Phase 1b trial for female patients, though higher doses remain restricted. Meanwhile, BTIG reiterated its Buy rating on VYNE Therapeutics, maintaining a positive outlook on the company’s future prospects in the vitiligo treatment market. Despite the recent trial results, BTIG anticipates that upcoming data could position Repibresib as a competitive treatment option.
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