VYNE Therapeutics Shares Disappointing Data From Atopic Dermatitis Trial

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  • VYNE Therapeutics Inc VYNE has announced results from the Phase 2a segment of Phase 1b/2a trial evaluating FMX114 for mild-to-moderate atopic dermatitis.
  • The study did not meet its primary endpoint based on the absolute and percent change relative to baseline in the Atopic Dermatitis Severity Index (ADSI).
  • The Phase 2a study of FMX114 enrolled 21 patients and was designed to evaluate four weeks of FMX114 treatment in patients with mild-to-moderate AD compared to vehicle control. 
  • Related: VYNE Therapeutics Shares Gain After Positive Atopic Dermatitis Trial Data Of FMX114.
  • Mean ADSI scores for FMX114 and vehicle-treated lesions were 6.6 and 6.9, respectively, at baseline.
  • The mean reduction in ADSI score from baseline was -4.05 (-60.62% mean reduction) for FMX114 treated lesions compared to -3.48 (-51.32% mean reduction) for vehicle-treated lesions at week 4.
  • "In addition, as a result of this outcome, our management team and our board of directors will evaluate the company's pipeline and prioritization of activities," said David Domzalski, CEO. 
  • The company expects to report cash and cash equivalents of approximately $43 million as of June 30.
  • Price Action: VYNE shares are down 33.50% at $0.27 on the last check Wednesday.
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