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) has announced a registered direct offering of 21,097,046 shares at $2.37 per share, expected to yield approximately $50 million in gross proceeds. This offering is set to close around January 28, 2021, subject to customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. Proceeds will be used for working capital and general corporate purposes. The shares are offered under an effective registration statement.
VYNE Therapeutics (Nasdaq: VYNE) has secured a contract with a major U.S. pharmacy benefit manager (PBM) for its topical foams AMZEEQ (minocycline) 4% and ZILXI (minocycline) 1.5%. AMZEEQ is FDA-approved for treating severe acne, while ZILXI targets inflammatory lesions of rosacea. This contract signifies a major milestone, granting access to millions of covered lives and aligning with VYNE's objective to enhance commercial coverage. Both products utilize VYNE's Molecule Stabilizing Technology, offering new avenues for treating these skin conditions.
VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced that CEO David Domzalski will participate in two panel discussions at the LifeSci Partners 10th Annual Healthcare Corporate Access Event. The first panel, titled Dermatology Innovation: Addressing Physician and Patient Underserved Needs, is scheduled for January 7 at 2:00 PM ET, followed by Executing a Successful Product Launch During a Pandemic on January 8 at the same time. Virtual Q&A will follow both sessions. For more details, visit the event's registration links.
VYNE Therapeutics has successfully concluded its End-of-Phase 2 Meeting with the FDA, setting the stage to initiate the TRILOGY Phase 3 program in 2021 for its innovative acne treatment FCD105. This minocycline-based combination product aims to address moderate-to-severe acne vulgaris, with results from a positive Phase 2 study showing strong efficacy. VYNE received FDA agreement on trial design, which includes two 12-week studies and one 40-week study, potentially expediting the New Drug Application submission.
VYNE Therapeutics Inc. (Nasdaq: VYNE) has been selected for inclusion in the NASDAQ Biotechnology Index, effective December 21, 2020. This index tracks biotechnology and pharmaceutical companies, with eligibility based on market capitalization and trading volume. VYNE, formed through the merger of Menlo Therapeutics and Foamix Pharmaceuticals, focuses on innovative dermatological therapies. The company's FDA-approved products include AMZEEQ and ZILXI, addressing significant dermatological needs.
VYNE Therapeutics announced the listing of a new U.S. patent for AMZEEQ in the FDA’s Orange Book, enhancing its protection in the dermatology market. The newly issued patent (U.S.10,849,847) extends coverage for AMZEEQ, a topical foam containing minocycline, which treats moderate to severe acne in patients aged 9 and older. This adds to 12 patents for AMZEEQ, with patent protection extending until September 2037. VYNE aims to strengthen its innovative portfolio in dermatology, addressing the needs of the 10 million Americans suffering from moderate to severe acne.
VYNE Therapeutics announced the publication of long-term safety and efficacy data for ZILXI (minocycline topical foam, 1.5%) in the Journal of Clinical and Aesthetic Dermatology. This study demonstrated a favorable safety profile over 52 weeks and efficacy that improved for an additional 40 weeks following an initial 12-week treatment phase. Key findings included an 82.3% mean reduction in inflammatory lesions, with 79.8% of subjects achieving treatment success. ZILXI is the first FDA-approved minocycline product for treating inflammatory lesions of rosacea.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced that CEO David Domzalski will participate in a fireside chat at the virtual Piper Sandler Healthcare Conference from December 1-3, 2020. The chat will be accessible to institutional clients starting December 1 via Piper Sandler’s event portal. VYNE, formed by the merger of Menlo Therapeutics and Foamix Pharmaceuticals in March 2020, specializes in innovative dermatological therapies. The company has received FDA approval for its products AMZEEQ® and ZILXI™, marking significant advancements in topical treatment options.
VYNE Therapeutics Inc. reported its third-quarter financial results for the period ending September 30, 2020. The company generated revenues of $3.3 million, primarily from AMZEEQ, marking a notable increase from the previous year. The launch of ZILXI on October 1 has enhanced its dermatology portfolio. The company experienced a net loss of $24.7 million but anticipates that its cash reserves of $76.9 million will sustain operations through 2021. Overall, prescription volumes for AMZEEQ have surged 52% in Q3, reflecting a recovery in the acne market.
VYNE Therapeutics Inc. (Nasdaq: VYNE) is set to report its third-quarter financial results for the period ending September 30, 2020, on November 5, 2020, before market hours. A conference call will be held at 8:30 a.m. ET to discuss the results and provide updates. VYNE specializes in developing innovative dermatological therapies, having received FDA approvals for AMZEEQ® and ZILXI™, both minocycline topical foams. The company emphasizes its commitment to improving patient lives through proprietary technologies.
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