H.C. Wainwright reiterates Buy rating on VYNE Therapeutics stock amid clinical hold update

Published 03/07/2025, 12:38
H.C. Wainwright reiterates Buy rating on VYNE Therapeutics stock amid clinical hold update

Investing.com - H.C. Wainwright has reiterated its Buy rating and $4.50 price target on VYNE Therapeutics (NASDAQ:VYNE), a small-cap biotech with a market capitalization of $25.2 million, following the company’s update on its VYN202 program for moderate-to-severe plaque psoriasis. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $4.50 to $10.00.

The FDA recently placed a clinical hold on the Phase 1b trial due to testicular toxicity findings in dogs during non-clinical studies, but has allowed the study to resume in female patients at the 0.25 mg and 0.5 mg doses. The higher 1 mg dose was excluded due to its lower safety margin, and VYNE must complete a 12-week non-clinical toxicology study in dogs before male enrollment can resume. The company’s strong liquidity position, with a current ratio of 4.47x and minimal debt, provides financial flexibility during this clinical development phase.

After the hold, VYNE unblinded data from the enrolled subjects (six treated, one placebo), revealing no serious side effects and no treatment discontinuations or interruptions due to side effects. No cases of thrombocytopenia, neutropenia, or lymphocytopenia were reported among the participants.

All subjects receiving VYN202 showed improvements in key disease indicators, with Psoriasis Area and Severity Index (PASI) score reductions ranging from approximately 27% after one week to about 90% by week eight. Subjects treated for more than one week also demonstrated meaningful reductions in serum cytokines (IL-17A, IL-17F, IL-19, IL-22), with decreases ranging from 17% to 83%, while no changes were observed in the placebo subject.

VYNE has decided to close enrollment in the Phase 1b study, a move that is expected to extend the company’s cash runway into the fourth quarter of 2026. While InvestingPro analysis indicates the company is quickly burning through cash, this strategic decision could help manage expenses. InvestingPro subscribers have access to 8 additional key financial tips and comprehensive financial health metrics for VYNE Therapeutics.

In other recent news, VYNE Therapeutics has been in the spotlight due to several significant developments. The company announced that the U.S. Food and Drug Administration (FDA) has partially lifted a clinical hold on its Phase 1b trial of VYN202 for moderate-to-severe plaque psoriasis. This allows VYNE to resume testing in female patients at specified dose levels, although enrollment in the study has been discontinued to extend the company’s cash runway. Preliminary results showed promising improvements in disease symptoms without serious adverse events. Meanwhile, VYNE’s Phase 2b trial of repibresib gel for nonsegmental vitiligo continues unaffected, with top-line results expected mid-year. Analyst firm BTIG has reiterated its Buy rating on VYNE, citing the potential for repibresib to become a preferred treatment for vitiligo. However, H.C. Wainwright has adjusted its price target for VYNE stock to $4.50, maintaining a Buy rating amidst the ongoing challenges with the VYN202 program. The company remains committed to resolving the clinical hold on VYN202 and advancing its product pipeline.

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