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 Inc. (Nasdaq: VYNE) announced that Chief Scientific Officer Iain Stuart, Ph.D., will present at the B&T Cell-Mediated Autoimmune Disease Drug Development Conference on July 27, 2022. The presentation, titled The InhiBET™ Platform: Bromodomain and End Terminal (BET) Inhibitors in Autoimmune Disease, will focus on harnessing autoantibody signatures. VYNE is developing innovative therapies for immuno-inflammatory conditions, including its proprietary treatments like FMX114 for atopic dermatitis and a library of BET domain inhibitors.
VYNE Therapeutics has completed patient enrollment for the Phase 2a clinical study of FMX114, focusing on treating mild-to-moderate atopic dermatitis. FMX114 is a novel gel combining tofacitinib and fingolimod. Earlier findings from a Phase 1b trial indicated significant improvements in the Atopic Dermatitis Severity Index and reduced itch. VYNE anticipates releasing top-line efficacy results within 6 to 8 weeks, emphasizing advancements despite challenges from the COVID-19 pandemic.
VYNE Therapeutics will present at the HC Wainwright & Co. Global Investment Conference on May 25, 2022, featuring CEO David Domzalski and CSO Dr. Iain Stuart. The presentation is scheduled for 9:00 a.m. ET and will be available via webcast. VYNE focuses on developing innovative therapies for immuno-inflammatory conditions, notably FMX114 for atopic dermatitis and VYN201 and VYN202 for BET inhibitors.
VYNE Therapeutics announced positive Phase 1b results for FMX114 in atopic dermatitis and promising preclinical data for VYN201, a BET inhibitor. The company reported a net income of $4.7 million for Q1 2022, a significant improvement from a net loss of $20.6 million in Q1 2021. Revenue remained stable at $0.2 million, primarily from royalty income. VYNE has completed the divestiture of its MST Franchise for $25 million, with additional milestone payments possible. Upcoming milestones include a Phase 2a study for FMX114 by Q2 2022.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will host a virtual Key Opinion Leader (KOL) event on May 17, 2022, focusing on its InhiBET™ BET Inhibitor Platform for treating immuno-inflammatory conditions, including vitiligo. The event will feature an overview of pan-BET inhibition and preclinical data for lead inhibitor VYN201. Notable speakers include Gerald V. Denis, PhD, and Thierry Passeron, MD, PhD. Registration is available online, and an archived version will be accessible for 90 days following the event.
BRIDGEWATER, N.J., May 06, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics (Nasdaq: VYNE) announced that CEO David Domzalski and Dr. Iain Stuart will present at LifeSci Partners’ virtual Immunology and Inflammation Symposium on May 10-11, 2022. The presentation is scheduled for 1:30 PM Eastern Time on May 10. A replay of the webcast will be available on VYNE's website for 90 days post-conference. VYNE focuses on innovative therapies for immuno-inflammatory conditions, with notable products including FMX114 for atopic dermatitis and a library of BET domain inhibitors.
VYNE Therapeutics Inc. announced promising results from the Phase 1b segment of their Phase 1b/2a clinical trial for FMX114, a gel for treating mild-to-moderate atopic dermatitis (AD). At week 2, FMX114 showed a significant reduction in the Atopic Dermatitis Severity Index (ADSI) score, with an 81.4% mean reduction compared to 54.3% for the vehicle. Additionally, a 96.4% mean reduction in itch severity was reported. The Phase 2a results are anticipated in Q2 2022, with FMX114 positioning to be a first-in-class topical treatment.
VYNE Therapeutics announced positive preclinical results for VYN201, a pan-BET inhibitor, in an animal model of rheumatoid arthritis. The study showed statistically significant improvements in treatment response at 1mg/kg and 10mg/kg doses, surpassing the leading steroid, dexamethasone, in reducing inflammation. VYN201's potential for broad therapeutic applications was emphasized, supported by a planned initiation of first-in-human clinical trials in the second half of 2022.
VYNE Therapeutics reported Q4 and full-year 2021 financial results, showing revenues of $14.8 million, down from $21.0 million in 2020. The net loss narrowed to $73.3 million, or $1.42 per share, compared to a loss of $255.6 million, or $7.88 per share, in the previous year. The company highlighted progress in its immuno-inflammatory pipeline, including positive Phase 1b data for FMX114. VYNE expects to present Phase 2a results for FMX114 and initiate its first human study for VYN201 in 2022, aiming to enhance shareholder value.
VYNE Therapeutics Inc. announced promising preclinical results for its BET inhibitor, VYN201, in treating vitiligo, an autoimmune skin disorder. The 0.1% and 1% concentrations of VYN201 significantly reduced melanocyte loss and pro-inflammatory biomarkers, outperforming the active control, ruxolitinib cream. Specifically, VYN201 demonstrated a 94.7% reduction in MMP-9 secretion and a 10-fold increase in melanin levels compared to the vehicle treatment. The company plans to advance VYN201 into human clinical trials later this year.