VYNE - VYNE Therapeutics reports successful FDA meeting for FCD105 in acne
VYNE Therapeutics (VYNE) perks up 6% premarket on successful completion its End-of-Phase 2 Meeting with the FDA.The Company, in consultation with the FDA, has established the key elements of the Phase 3 program to support a New Drug Application ((NDA)) for FCD105 (3% minocycline / 0.3% adapalene foam), the first ever minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. The meeting was supported by non-clinical safety, CMC and clinical information, including results from the previously completed positive Phase 2 study.The company looks forward to commence the program next year.
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VYNE Therapeutics reports successful FDA meeting for FCD105 in acne