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 (Nasdaq: VYNE) has enrolled the first patient in a Phase 1b/2a clinical trial for FMX114, aimed at treating mild-to-moderate atopic dermatitis (AD). The investigational gel combines tofacitinib and fingolimod, targeting inflammation through dual mechanisms. The trial will assess safety and efficacy with a total of 31 subjects over various phases. Topline results are anticipated in early Q1 2022, marking a significant step in VYNE's strategy to develop innovative therapies for immuno-inflammatory diseases.
VYNE Therapeutics has announced the enrollment of the first patient in a Phase 3 study in China for AMZEEQ® (minocycline) topical foam, 4%, targeting moderate to severe acne. Conducted by Cutia Therapeutics, this study aims to secure regulatory approval for the product in China, expanding VYNE’s market reach. The study will enroll 372 patients across 29 sites, with the primary endpoint measuring changes in inflammatory lesion counts at Week 12. VYNE's licensing agreement with Cutia positions the company to earn royalties on net sales of AMZEEQ.
VYNE Therapeutics announced that David Domzalski, CEO, will present at the Cantor Fitzgerald Virtual Global Healthcare Conference from September 27-30, 2021. His presentation, a fireside chat, is scheduled for September 28 at 4 PM ET and will be available for archiving for 90 days. VYNE aims to enhance patient lives through innovative treatments for immuno-inflammatory conditions, with ongoing projects including FCD105 for acne and FMX114 for atopic dermatitis. VYNE has received FDA approvals for AMZEEQ and ZILXI, both minocycline topical products.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced that CEO David Domzalski will present at the H.C. Wainwright 23rd Annual Global Investment Conference, held virtually from September 13-15, 2021. The presentation will be a fireside chat available on demand starting September 13 at 7:00 AM (ET) and can be accessed for 90 days. Additionally, management will be available for one-on-one investor meetings. VYNE focuses on innovative therapies for immuno-inflammatory conditions and has FDA-approved products for acne and rosacea.
VYNE Therapeutics announced a license agreement for its BETi platform with In4Derm Limited and initiated a process to sell or license its topical minocycline franchise, aiming to reduce operating expenses significantly. The company plans to focus on immuno-inflammatory diseases and expects Phase 2a results for FMX114 by year-end. Financially, VYNE reported revenues of $4.3 million for Q2 2021, down from $11.7 million the previous year. Net loss for the quarter was $19.9 million, with a considerable reduction in operating costs anticipated.
VYNE Therapeutics (Nasdaq: VYNE) has announced an exclusive licensing agreement with In4Derm Limited to access a new chemical entities library focusing on Bromodomain and Extra-Terminal Domain inhibitors for treating inflammatory and oncology conditions. The partnership aims to develop VYN201 and VYN202, a topical and an oral BET inhibitor respectively, targeting rare skin diseases and major immuno-inflammatory conditions. VYNE plans to initiate clinical trials for these products in 2022. The deal includes upfront and milestone payments potentially reaching $59.5 million, along with tiered royalties.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced the approval of its topical products AMZEEQ® (minocycline) foam, 4%, and ZILXI® (minocycline) foam, 1.5%, for sale in a pilot program in Hainan Boao Lecheng, China. Cutia Therapeutics will market these products in Greater China under an exclusive licensing agreement. This pilot zone allows for innovative treatments not registered with Chinese authorities to be available to patients, potentially aiding in data collection for future regulatory approval. Both products have been previously FDA approved in the U.S.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will report its financial results for Q2 2021 on August 12, 2021, before the market opens. A conference call is scheduled for 8:30 a.m. ET to discuss these results and provide a corporate update. VYNE focuses on developing innovative therapies, including FDA-approved products AMZEEQ® and ZILXI®, utilizing its proprietary Molecule Stabilizing Technology (MST™). For further details, visit their website or follow their upcoming call.
VYNE Therapeutics Inc. has initiated a clinical trial for AMZEEQ (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne. Conducted at the Austin Institute for Clinical Research, the trial aims to assess safety, efficacy, and tolerability over a 20-week treatment period. The study will also evaluate AMZEEQ's impact on common adverse reactions of isotretinoin. Approximately 30 patients will be enrolled. AMZEEQ already has FDA approval for treating inflammatory lesions of acne vulgaris.
VYNE Therapeutics announced that Dr. Iain Stuart will moderate a scientific panel discussion at the 2nd Annual JAK Inhibitors Drug Development Digital Event, occurring from June 29 to July 1, 2021. The discussion, set for June 30 at 2:40 PM Eastern Time, will focus on combinational opportunities with JAK inhibitors and ongoing research trends in immunology. The event aims to address the lack of JAK inhibitors in specific disease profiles and explore the potential benefits of combination therapeutic approaches.
FAQ
What is the current stock price of Vyne Therapeutics (VYNE)?
What is the market cap of Vyne Therapeutics (VYNE)?
