Welcome to our dedicated page for Vyne Therapeutics news (Ticker: VYNE), a resource for investors and traders seeking the latest updates and insights on Vyne Therapeutics stock.
Vyne Therapeutics Inc. (VYNE) is a clinical-stage biopharmaceutical company pioneering novel therapies for immuno-inflammatory conditions and dermatologic disorders. This dedicated news hub provides investors and industry professionals with timely updates on Vyne's clinical trials, regulatory milestones, and scientific advancements.
Access authoritative information on Vyne's BET inhibitor pipeline, including BD2-selective candidates like VYN201 (topical) and VYN202 (oral), designed to address chronic inflammatory diseases with improved safety profiles. Our curated news collection covers essential developments across preclinical research, FDA communications, and strategic partnerships.
Key updates include progress in treating conditions such as prurigo nodularis, vitiligo, and atopic dermatitis through Vyne's proprietary InhiBET platform. Bookmark this page for real-time notifications on Phase 2 trial results, intellectual property developments, and analyses of Vyne's position within the dermatology therapeutics market.
VYNE Therapeutics has commenced dosing the first subject in its Phase 2b trial for VYN201, a novel BET inhibitor gel, aimed at treating nonsegmental vitiligo. This 24-week, double-blind, vehicle-controlled study will evaluate the safety and efficacy of once-daily VYN201 gel in three concentrations: 1%, 2%, and 3%. Approximately 160 subjects will be randomized in a 1:1:1:1 ratio. Following the initial treatment period, active treatment subjects will continue for another 28 weeks, while vehicle group subjects will be re-randomized to one of the VYN201 concentrations. The study's primary endpoint is achieving a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24. Top-line data are expected by mid-2025. Early Phase 1b results showed VYN201's rapid clinical response and favorable safety profile, suggesting it could become a differentiated therapy for vitiligo patients.
VYNE Therapeutics Inc. reported its First Quarter 2024 Financial Results and provided a business update. The company made steady progress on its VYN201 program towards a Phase 2b trial, with the design finalized. IND clearance was received for VYN202, with expectations to dose healthy volunteers in Phase 1a trial this quarter.
Financially, VYNE had $86.0 million in cash and marketable securities as of March 31, 2024, believed to be sufficient to fund operations through 2025. Revenues were $0.1 million for Q1 2024 and 2023, mainly from royalty revenue. Research and development expenses increased by 35.6%, and general and administrative expenses increased by 16.4%.
VYNE Therapeutics announced the FDA clearance of its Investigational New Drug application for VYN202, a novel BD2-selective BET inhibitor. In preclinical studies, VYN202 showed consistent reductions in biomarkers and disease severity across various inflammatory and fibrotic models. The Phase 1a trial in healthy volunteers is set to begin this quarter, with top line results expected in the second half of the year.
VYNE Therapeutics announced that two abstracts reporting positive preclinical and Phase 1b data of their novel BET inhibitor, VYN201, have been selected for presentation at the 2024 Society for Investigative Dermatology Annual Meeting. The company aims to develop VYN201 as a differentiated therapy for nonsegmental vitiligo.
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