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 initiated a Phase 1a/b clinical trial for VYN201, a BET inhibitor targeting vitiligo treatment. The trial aims to establish safety and pharmacokinetics in healthy volunteers and assess early efficacy in vitiligo patients. Phase 1a involves up to 30 healthy participants, while Phase 1b will treat up to 30 diagnosed patients. Topline results are anticipated in the first half of 2023. VYN201 demonstrates promise in reducing skin pigment loss and has shown efficacy in preliminary studies, positioning it as a novel therapeutic option for vitiligo.
VYNE Therapeutics announced the receipt of IND clearance for its pan-BD BET inhibitor, VYN201, targeting vitiligo, with patient enrollment for a Phase 1a/b trial expected this month. The company is also advancing its oral BET inhibitor program, VYN202, in collaboration with Tay Therapeutics. Additionally, analysis of the FMX114 Phase 2a trial indicates potential efficacy for moderate-to-severe atopic dermatitis, despite initial statistical insignificance at week 4. Financially, VYNE reported a net loss of $9.5 million for Q3 2022, a decrease from $21.3 million in Q3 2021.
VYNE Therapeutics announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022. CEO David Domzalski will present at 12:30 p.m. ET and is available for one-on-one meetings with investors. VYNE focuses on innovative therapies for immuno-inflammatory conditions using its unique bromodomain and extra-terminal domain platform, including lead programs VYN201 and VYN202. A replay of the presentation will be accessible on VYNE's website for 90 days.
VYNE Therapeutics Inc. (VYNE) reported its financial results for the second quarter and first half of 2022. For Q2, the company posted a net loss of $8.5 million, significantly down from $19.9 million in Q2 2021. Revenues fell to $0.1 million compared to $0.3 million the previous year, primarily from royalty revenue. Research and development expenses decreased by 18.6% to $4.1 million, while selling, general, and administrative expenses declined by 10.1% to $4.3 million. VYNE has $42.8 million in cash reserves, expected to fund operations into Q3 2023.
VYNE Therapeutics Inc. reported disappointing results from the Phase 2a trial of FMX114 for treating mild-to-moderate atopic dermatitis, failing to meet its primary endpoint. In this study involving 21 patients, FMX114 showed a mean reduction of 60.62% in the Atopic Dermatitis Severity Index (ADSI) compared to 51.32% for the vehicle control (p=0.228). VYNE has approximately $43 million in cash and is set to receive a $5 million payment in January 2023. The management will review the trial data and reassess the company’s pipeline strategy moving forward.
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.