Investing.com -- VYNE Therapeutics (NASDAQ: VYNE ) stock plummeted 20.2% following the company’s announcement that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on their Phase 1b study of VYN202, a treatment for moderate-to-severe plaque psoriasis. This decision comes after an observation of testicular toxicity in dogs during a non-clinical toxicology study.

The company, based in Bridgewater, New Jersey, has halted all screening, enrollment, and dosing of patients in the VYN202 trial. Despite this setback, VYNE has reported no serious adverse events in the subjects enrolled in the study thus far. VYNE’s leadership expressed their commitment to resolving the clinical hold swiftly and to continue discussions with the FDA.

In contrast, the clinical hold does not affect VYNE’s ongoing Phase 2b trial of repibresib gel for nonsegmental vitiligo, which is a separate compound from VYN202. The company anticipates top-line results from the repibresib trial by mid-year.

David Domzalski, President and CEO of VYNE, commented on the situation, "While we are disappointed by this unexpected development, the safety and well-being of patients in our studies is our top priority. We intend to work closely with the FDA to address the clinical hold as expeditiously as possible and we plan to provide additional updates pending continued engagement with FDA."

In light of these events, H.C. Wainwright analyst Joseph Pantginis maintained a Buy rating on VYNE stock but reduced the price target from $5.75 to $4.50. Pantginis outlined several factors that could potentially hinder the company’s ability to reach the price target, including "failed or inconclusive clinical trials, the inability of the company to secure adequate funding to progress its products through the development pathway or the occurrence of dilutive capital raises, lack of commercial success, and de-listing risk."

Investors are closely monitoring VYNE’s next moves as they navigate the challenges presented by the FDA’s clinical hold and strive to advance their product pipeline.

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