FDA Puts VYNE Therapeutics Early-Stage Psoriasis Study On Hold

The U.S. Food and Drug Administration (FDA) on Friday verbally informed that it placed a clinical hold on VYNE Therapeutics Inc.’s VYNE 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.

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To date, no serious adverse events have been observed in subjects enrolled in the Phase 1b study.

In February, VYNE Therapeutics dosed the first subject in a Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis.

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-2025.

In December 2024, VYNE Therapeutics released results from the multiple ascending dose portion of its Phase 1a SAD/MAD trial of VYN202.

Consistent with Phase 1a SAD results released in September 2024, VYN202 demonstrated a favorable safety and tolerability profile with no drug-related adverse events historically associated with earlier-generation, less selective BET inhibitors.

As of December 31, 2024, VYNE had $61.5 million of cash, cash equivalents, and marketable securities, which is expected to be sufficient to fund its operations into the second half of 2026.

Price Action: VYNE stock is down 23.9% at $1.43 at the last check Friday.

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