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. (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 announced its participation in one-on-one investor meetings at the LifeSci Partners 11th Annual Corporate Access Event, scheduled virtually from January 5-7, 2022. The Company aims to enhance patient care through innovative therapies targeting immuno-inflammatory conditions. Key products include FMX114 for mild-to-moderate atopic dermatitis and a range of BET domain inhibitors for various conditions. Investors are encouraged to visit VYNE's website for further updates and disclosures.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will participate in the Piper Sandler 33rd Annual Virtual Healthcare Conference, with CEO David Domzalski presenting a pre-recorded fireside chat available on the Company’s website starting November 22, 2021. The chat will commence at 10:00 a.m. Eastern Time. Additionally, VYNE management will hold 1-on-1 meetings with investors during the conference, scheduled from November 29 to December 2.
VYNE aims to develop innovative therapies for immuno-inflammatory conditions and rare skin diseases.
VYNE Therapeutics reported Q3 2021 revenues of $4.1 million, a rise from $3.3 million in Q3 2020, driven mainly by product sales. The company posted a net loss of $21.3 million, reducing from $24.7 million year-over-year. VYN201, the lead BET inhibitor candidate, showed significant promise in preclinical studies, reducing key pro-inflammatory cytokines and improving skin repair. VYNE expects to enter clinical trials for VYN201 in 2022 and anticipates Phase 2a results for FMX114 in early Q1 2022. The divestment process for its topical minocycline franchise is advancing successfully.
VYNE Therapeutics announced promising preclinical data for its BET inhibitor, VYN201, in treating autoimmune skin diseases. The study on hairless mice showed VYN201 significantly improved skin healing, reducing lesion severity scores and healing time compared to negative controls. Lesions treated with VYN201 healed in a mean time of 15.5 days versus 21 days for controls. Additionally, VYN201 treatment led to less fibrotic tissue, resulting in enhanced scar appearance. These results support the continued development of VYN201, aiming to address significant unmet medical needs in skin diseases.
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.
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