VYNE Therapeutics Inc. develops differentiated therapies for chronic inflammatory and immune-mediated conditions through proprietary BET inhibitor programs. News about VYNE centers on its InhiBET™ platform, Repibresib gel for nonsegmental vitiligo, and VYN202, an oral BD2-selective BET inhibitor being evaluated for immune-mediated diseases.
Company updates also cover clinical and regulatory communications, nonclinical toxicology work, quarterly operating results, cost-control actions, capital-structure matters, governance developments, and shareholder voting matters tied to its Nasdaq-listed common stock.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will announce its third-quarter financial results for the period ending September 30, 2021, on November 10, 2021, before market opening. A conference call and webcast will take place at 8:30 AM ET to discuss the results and provide updates on corporate developments. VYNE aims to improve patient lives through innovative therapies for immuno-inflammatory conditions and has a pipeline including FMX114 for atopic dermatitis.
VYNE Therapeutics Inc. announced promising preclinical data for its BET inhibitor, VYN201, demonstrating significant reductions in pro-inflammatory cytokines linked to Th17-mediated autoimmune diseases. In a murine model, a 0.1% dose of VYN201 achieved a 94% reduction in inflammation severity compared to vehicle controls, showing efficacy similar to a super-potent glucocorticosteroid. Furthermore, VYN201 exhibited better tolerance than clobetasol propionate, with treated mice showing normal weight gain. The compound also outperformed the JAK1/2 inhibitor ruxolitinib in ex vivo human skin tissue studies.
VYNE Therapeutics Inc. (Nasdaq: VYNE) has formed a Scientific Advisory Board (SAB) to support its strategy in developing novel treatments for immunological and inflammatory diseases. The SAB comprises leading experts who will provide guidance on the company’s pipeline, including its BET inhibitor drug candidates and FMX114 for atopic dermatitis. CEO David Domzalski emphasized the SAB’s role in optimizing the development of the company’s innovative therapies, aimed at addressing significant unmet medical needs in the treatment of these conditions.
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.