FDA Places Clinical Hold On VYNE Therapeutics' Phase 1b Study For VYN202 Following Safety Concerns

BRIDGEWATER, N.J., April 25, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company's Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis. The clinical hold determination was made following a recent observation of testicular toxicity in dogs from a non-clinical toxicology study with VYN202.

VYNE has suspended all screening, enrollment and patient dosing in the Phase 1b trial of VYN202 and intends to work diligently with the FDA to resolve the clinical hold as soon as possible. To date, there have been no serious adverse events observed in subjects that have been enrolled in the Phase 1b study.

The clinical hold does not apply to VYNE's ongoing Phase 2b trial of repibresib gel in nonsegmental vitiligo. Repibresib is a distinct and unique compound from VYN202. Top-line results from the 24-week double-blind, vehicle-controlled portion of the Phase 2b trial are expected mid-year.