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BRIDGEWATER, N.J. - VYNE Therapeutics Inc. (NASDAQ:VYNE) announced today that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the biopharmaceutical company’s Phase 1b trial of VYN202, a treatment candidate for moderate-to-severe plaque psoriasis. The hold was initiated following the discovery of testicular toxicity in dogs during a non-clinical toxicology study of VYN202. According to InvestingPro data, VYNE maintains a strong liquidity position with a current ratio of 4.35, holding more cash than debt on its balance sheet, though the company has been rapidly burning through its cash reserves.
In response, VYNE has halted all screening, enrollment, and dosing of patients in the affected study. Despite the setback, no serious adverse events have been reported in the human subjects enrolled in the Phase 1b trial to date. VYNE’s leadership expressed their commitment to patient safety and their intention to work closely with the FDA to address the hold promptly.
The clinical hold does not impact another of VYNE’s trials, a Phase 2b study of repibresib gel for nonsegmental vitiligo, which is ongoing. Repibresib is a different compound from VYN202, and the company expects to report top-line results from this trial around mid-year.
VYNE specializes in developing treatments for chronic inflammatory and immune-mediated conditions. The company’s proprietary BET inhibitors are a part of its InhiBET platform, which aims to improve upon earlier generations of BET inhibitors.
This announcement is based on a press release statement from VYNE Therapeutics Inc. and reflects the current situation as of today. The resolution of the clinical hold and future developments concerning VYNE’s clinical trials remain contingent on further discussions with the FDA.
In other recent news, VYNE Therapeutics has initiated a Phase 1b clinical trial for its drug candidate VYN202, targeting moderate-to-severe plaque psoriasis. The trial, which aims to enroll up to 80 patients, will evaluate the safety of VYN202, an oral small molecule inhibitor designed to target BET proteins linked to inflammatory diseases. The study will measure efficacy through improvements in the Psoriasis Area and Severity Index (PASI) scores. Topline results from this 12-week placebo-controlled treatment period are expected by the end of 2025. H.C. Wainwright has reiterated a Buy rating on VYNE, maintaining a price target of $5.75, reflecting a positive outlook on the company’s recent advancements. The firm’s analyst highlighted the strategic selection of plaque psoriasis as the initial indication for VYN202. VYNE’s earlier Phase 1a results indicated that VYN202 was safe and effectively inhibited inflammatory biomarkers. The company has sufficient cash to fund operations into 2026 and may explore additional trials for other inflammatory diseases.
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