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VYNE Therapeutics Inc. (Nasdaq: VYNE) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for dermatological and immuno-inflammatory conditions. Headquartered in Bridgewater, New Jersey, the company was founded in 2003 and initially known as Menlo Therapeutics Inc. before rebranding to VYNE Therapeutics Inc. in September 2020.
VYNE's portfolio includes AMZEEQ, a topical minocycline foam approved for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older. Another key product is ZILXI, which has shown efficacy in managing acne vulgaris. Additionally, VYNE is developing FMX103, presently in Phase III clinical trials aimed at treating moderate-to-severe papulopustular rosacea in adults, and FCD105, a topical combination foam in Phase II trials for moderate-to-severe acne vulgaris.
Expanding its focus, VYNE is advancing the development of serlopitant, a once-daily oral NK1 receptor antagonist, as a treatment for pruritus associated with prurigo nodularis. The company is also innovating in the immuno-inflammatory space with its InhiBET™ platform, featuring advanced product candidates like VYN202 and VYN201. VYN202, an oral small molecule BD2-selective BET inhibitor, has demonstrated promising preclinical results for psoriasis and rheumatoid arthritis. VYN201, designed for local administration, is targeting nonsegmental vitiligo and has shown positive Phase 1b clinical trial results.
Recent developments highlight VYNE's commitment to advancing its pipeline, including the initiation of a Phase 2b trial for VYN201 in vitiligo and clearance of the Investigational New Drug (IND) application by the FDA for VYN202, paving the way for its first-in-human studies.
VYNE Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the Leerink Partners Therapeutics Forum scheduled for July 9, 2024. The event will focus on Immunology & Inflammation (I&I) and Metabolic Diseases. VYNE will engage in one-on-one meetings to discuss their proprietary and innovative therapies for immuno-inflammatory conditions. The company aims to showcase its developments and strengthen its position within the biopharmaceutical field. This participation highlights VYNE's commitment to advancing treatments for critical health issues.
VYNE Therapeutics has initiated dosing in the Phase 1a trial of its novel BD2-selective BET inhibitor, VYN202. This first-in-human, double-blind, placebo-controlled study will enroll around 64 healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VYN202.
The trial includes single ascending dose (SAD) and multiple ascending dose (MAD) components, with top-line data expected in the second half of 2024. VYN202 aims to treat immuno-inflammatory diseases by selectively targeting the BD2 bromodomain of BET proteins, potentially offering a better benefit-risk profile.
Preclinical testing has shown promising results in reducing disease severity and biomarkers. VYNE is optimistic about VYN202's potential to address a range of immune-mediated diseases.
VYNE Therapeutics has commenced dosing the first subject in its Phase 2b trial for VYN201, a novel BET inhibitor gel, aimed at treating nonsegmental vitiligo. This 24-week, double-blind, vehicle-controlled study will evaluate the safety and efficacy of once-daily VYN201 gel in three concentrations: 1%, 2%, and 3%. Approximately 160 subjects will be randomized in a 1:1:1:1 ratio. Following the initial treatment period, active treatment subjects will continue for another 28 weeks, while vehicle group subjects will be re-randomized to one of the VYN201 concentrations. The study's primary endpoint is achieving a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24. Top-line data are expected by mid-2025. Early Phase 1b results showed VYN201's rapid clinical response and favorable safety profile, suggesting it could become a differentiated therapy for vitiligo patients.
VYNE Therapeutics Inc. reported its First Quarter 2024 Financial Results and provided a business update. The company made steady progress on its VYN201 program towards a Phase 2b trial, with the design finalized. IND clearance was received for VYN202, with expectations to dose healthy volunteers in Phase 1a trial this quarter.
Financially, VYNE had $86.0 million in cash and marketable securities as of March 31, 2024, believed to be sufficient to fund operations through 2025. Revenues were $0.1 million for Q1 2024 and 2023, mainly from royalty revenue. Research and development expenses increased by 35.6%, and general and administrative expenses increased by 16.4%.
VYNE Therapeutics announced the FDA clearance of its Investigational New Drug application for VYN202, a novel BD2-selective BET inhibitor. In preclinical studies, VYN202 showed consistent reductions in biomarkers and disease severity across various inflammatory and fibrotic models. The Phase 1a trial in healthy volunteers is set to begin this quarter, with top line results expected in the second half of the year.
VYNE Therapeutics announced that two abstracts reporting positive preclinical and Phase 1b data of their novel BET inhibitor, VYN201, have been selected for presentation at the 2024 Society for Investigative Dermatology Annual Meeting. The company aims to develop VYN201 as a differentiated therapy for nonsegmental vitiligo.
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