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 announced its Q1 2021 financial results, reporting revenues of $4.1 million, a significant increase from $1.8 million in Q1 2020, primarily driven by the launches of AMZEEQ and ZILXI. The net loss narrowed to $20.6 million compared to $40.2 million in the prior year. VYNE plans to initiate a Phase 2a study for FMX114, a new treatment for atopic dermatitis, in Q3 2021. The company also raised $73.1 million through a stock offering and executed a 1-for-4 reverse stock split, strengthening its cash position to $120.4 million.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced it will report its financial results for Q1 2021 on May 6, 2021, before market opens. A conference call will follow at 8:30 a.m. ET to discuss these results and provide a corporate update. VYNE focuses on developing innovative dermatological therapies, having received FDA approvals for AMZEEQ® and ZILXI®. Investors can access a replay of the call on VYNE's website post-event.
VYNE Therapeutics announced that CEO David Domzalski will present at the Barclays Global Healthcare Conference and H.C. Wainwright Global Life Sciences Conference on March 9, 2021. The Barclays conference will include a fireside chat at 8:00 AM Eastern Time, with a webcast available at this link. The H.C. Wainwright conference will be available on demand starting at 7:00 AM Eastern Time on the same day, with a webcast link at this link.
VYNE Therapeutics reported financial results for Q4 and the full year of 2020, showing revenues of $21 million, up from $0.4 million in 2019. The company's net loss was $255.6 million, driven by significant expenses from R&D and impairments. VYNE launched its topical products ZILXI and AMZEEQ, gaining market traction in acne and rosacea. Key developments include plans for a Phase 3 trial for FCD105 and a Phase 2a study for FMX114 targeting atopic dermatitis, expected to yield results by year-end. The company has sufficient cash to fund operations through 2022.
VYNE Therapeutics Inc. announced that CEO David Domzalski will present at the Cowen 41st Annual Health Care Conference on March 2, 2021, at 2:10 PM ET. The presentation will be in a fireside chat format, providing insights into the company's innovative therapies in dermatology, including AMZEEQ® and ZILXI®, both FDA-approved minocycline products. For those interested, the webcast link is here. VYNE aims to enhance the lives of patients through proprietary therapies.
VYNE Therapeutics announced promising preclinical data for FMX114, a topical gel designed to treat mild-to-moderate atopic dermatitis (AD). The Phase 2a clinical study is set to begin in the third quarter of 2021, with top-line results expected by year-end. In animal studies, FMX114 demonstrated an 89% reduction in the modified atopic dermatitis index score compared to control. VYNE plans to discuss further details during the year-end earnings call on March 4, 2021.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will report its financial results for the year ended December 31, 2020, on March 4, 2021, before market opening. The company will host a conference call at 8:30 a.m. ET to discuss the results and provide a corporate update. VYNE focuses on developing innovative dermatological therapies and has FDA approval for AMZEEQ and ZILXI, both minocycline topical products for acne and rosacea, respectively. This announcement indicates VYNE's ongoing commitment to transparency and communication with investors.
VYNE Therapeutics has announced a 1-for-4 reverse stock split effective February 16, 2021, to consolidate its shares from approximately 205 million to about 51 million. This move aims to align its share count with companies of similar market capitalizations. Stockholders will receive cash for any fractional shares following the split. The reverse stock split was earlier approved by stockholders at the Annual Meeting on August 3, 2020. The company's trading symbol will remain VYNE, and the new CUSIP number will be 92941V 209.
VYNE Therapeutics announced FDA approval for a label update of AMZEEQ® (minocycline) topical foam, which confirms a low propensity for P. acnes to develop resistance to minocycline. This update is significant for treating inflammatory lesions of moderate to severe acne in patients aged 9 and older. The label states spontaneous mutation frequencies for resistance are less than 1 in 100 million. CEO David Domzalski emphasized this information aids dermatologists in antibiotic choices, while the update is backed by a comprehensive antimicrobial characterization program.
VYNE Therapeutics has completed a registered direct offering of 21,097,046 shares of common stock at $2.37 per share, raising approximately $46.7 million in net proceeds. These funds will be used for working capital and general corporate purposes. Previously, VYNE raised an additional $34.3 million via an at-the-market program, bringing total net proceeds to $81.0 million. The company anticipates this cash influx will cover its operational and capital needs through the end of 2022, allowing for the termination of its at-the-market program.
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