VYNE - Vyne sheds 31% as mid-stage trial for atopic dermatitis candidate fails

The shares of nano-cap pharma VYNE Therapeutics ( NASDAQ: VYNE ) fell ~31% in the pre-market Wednesday after the company announced that its atopic dermatitis candidate FMX114 failed to reach the main goal in a mid-stage study.

The Phase 2a segment of a Phase 1b/2a clinical trial was designed to evaluate FMX114 against a vehicle control in 21 patients with mild-to-moderate AD.

The trial named VY2021-01 did not meet the primary endpoint based on the Atopic Dermatitis Severity Index (“ADSI”) in terms of the absolute and percent change from the baseline.

The mean ADSI scores for FMX114 and vehicle treated lesions stood at 6.6 and 6.9, respectively, at baseline. At week 4, the decline in ADSI scores from the baseline reached -4.05 and -3.48 for FMX114 treated and vehicle-treated lesions, respectively (p=0.228).

The company plans to complete the analysis and review the full data set, Chief Executive of Vyne ( VYNE ) David Domzalski said, adding “as a result of this outcome, our management team and our board of directors will evaluate the Company’s pipeline and prioritization of activities.”

For June 30, the company expects to report $43M of cash and cash equivalents.

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