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.
News and disclosures about VYNE Therapeutics Inc. (VYNE) focus on its progress as a clinical-stage biopharmaceutical company developing BET inhibitor therapies for chronic inflammatory and immune-mediated conditions. Company press releases and SEC-referenced announcements cover clinical trial milestones, program updates, financial results and strategic transactions.
Investors following VYNE news can track detailed updates on its two principal BET inhibitor programs. For VYN202, an oral BD2-selective BET inhibitor, the company has issued multiple releases describing Phase 1b clinical data in moderate-to-severe plaque psoriasis, interactions with the U.S. Food and Drug Administration, and the impact of a clinical hold related to non-clinical toxicology findings in dogs. These communications outline protocol changes, preliminary safety and exploratory efficacy observations, and plans for additional toxicology work.
For repibresib gel, a locally administered pan-BD BET inhibitor, VYNE’s news flow includes topline results from a Phase 2b trial in nonsegmental vitiligo, analysis of primary and secondary endpoints, and the decision to discontinue the extension phase and terminate the trial. Releases also discuss the company’s intention to seek a development and commercialization partner for this program.
Regular financial news from VYNE includes quarterly and annual results, cash runway commentary, and descriptions of research and development and general and administrative spending. The company has also reported on a board-initiated strategic review to evaluate options such as partnerships, licensing, mergers or asset sales, and on cost reductions intended to extend its cash runway.
A major recent news theme is VYNE’s definitive merger agreement with Yarrow Bioscience, Inc. Announcements describe the all-stock transaction, expected ownership split between pre-merger stockholders, planned rebranding of the combined company as Yarrow Bioscience, Inc., and a future Nasdaq ticker symbol “YARW,” subject to closing conditions. Readers who monitor this news page can review the evolving narrative of VYNE’s pipeline, regulatory interactions, financial position and corporate transformation through official releases and referenced filings.
VYNE Therapeutics has initiated dosing in the Phase 1a trial of its novel BD2-selective BET inhibitor, VYN202. This first-in-human, double-blind, placebo-controlled study will enroll around 64 healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VYN202.
The trial includes single ascending dose (SAD) and multiple ascending dose (MAD) components, with top-line data expected in the second half of 2024. VYN202 aims to treat immuno-inflammatory diseases by selectively targeting the BD2 bromodomain of BET proteins, potentially offering a better benefit-risk profile.
Preclinical testing has shown promising results in reducing disease severity and biomarkers. VYNE is optimistic about VYN202's potential to address a range of immune-mediated diseases.
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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