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 positive Phase 1b results for FMX114 in atopic dermatitis and promising preclinical data for VYN201, a BET inhibitor. The company reported a net income of $4.7 million for Q1 2022, a significant improvement from a net loss of $20.6 million in Q1 2021. Revenue remained stable at $0.2 million, primarily from royalty income. VYNE has completed the divestiture of its MST Franchise for $25 million, with additional milestone payments possible. Upcoming milestones include a Phase 2a study for FMX114 by Q2 2022.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will host a virtual Key Opinion Leader (KOL) event on May 17, 2022, focusing on its InhiBET™ BET Inhibitor Platform for treating immuno-inflammatory conditions, including vitiligo. The event will feature an overview of pan-BET inhibition and preclinical data for lead inhibitor VYN201. Notable speakers include Gerald V. Denis, PhD, and Thierry Passeron, MD, PhD. Registration is available online, and an archived version will be accessible for 90 days following the event.
BRIDGEWATER, N.J., May 06, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics (Nasdaq: VYNE) announced that CEO David Domzalski and Dr. Iain Stuart will present at LifeSci Partners’ virtual Immunology and Inflammation Symposium on May 10-11, 2022. The presentation is scheduled for 1:30 PM Eastern Time on May 10. A replay of the webcast will be available on VYNE's website for 90 days post-conference. VYNE focuses on innovative therapies for immuno-inflammatory conditions, with notable products including FMX114 for atopic dermatitis and a library of BET domain inhibitors.
VYNE Therapeutics Inc. announced promising results from the Phase 1b segment of their Phase 1b/2a clinical trial for FMX114, a gel for treating mild-to-moderate atopic dermatitis (AD). At week 2, FMX114 showed a significant reduction in the Atopic Dermatitis Severity Index (ADSI) score, with an 81.4% mean reduction compared to 54.3% for the vehicle. Additionally, a 96.4% mean reduction in itch severity was reported. The Phase 2a results are anticipated in Q2 2022, with FMX114 positioning to be a first-in-class topical treatment.
VYNE Therapeutics announced positive preclinical results for VYN201, a pan-BET inhibitor, in an animal model of rheumatoid arthritis. The study showed statistically significant improvements in treatment response at 1mg/kg and 10mg/kg doses, surpassing the leading steroid, dexamethasone, in reducing inflammation. VYN201's potential for broad therapeutic applications was emphasized, supported by a planned initiation of first-in-human clinical trials in the second half of 2022.
VYNE Therapeutics reported Q4 and full-year 2021 financial results, showing revenues of $14.8 million, down from $21.0 million in 2020. The net loss narrowed to $73.3 million, or $1.42 per share, compared to a loss of $255.6 million, or $7.88 per share, in the previous year. The company highlighted progress in its immuno-inflammatory pipeline, including positive Phase 1b data for FMX114. VYNE expects to present Phase 2a results for FMX114 and initiate its first human study for VYN201 in 2022, aiming to enhance shareholder value.
VYNE Therapeutics Inc. announced promising preclinical results for its BET inhibitor, VYN201, in treating vitiligo, an autoimmune skin disorder. The 0.1% and 1% concentrations of VYN201 significantly reduced melanocyte loss and pro-inflammatory biomarkers, outperforming the active control, ruxolitinib cream. Specifically, VYN201 demonstrated a 94.7% reduction in MMP-9 secretion and a 10-fold increase in melanin levels compared to the vehicle treatment. The company plans to advance VYN201 into human clinical trials later this year.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced that CEO David Domzalski will participate in a virtual fireside chat at the 42nd Annual Cowen Healthcare Conference on March 8, 2022, at 12:50 p.m. ET. The conference will provide an opportunity for investors to engage in 1-on-1 meetings with management. A webcast of the presentation is accessible via the provided link, and a replay will be available on the VYNE website for 90 days post-event. VYNE focuses on developing innovative therapies for immuno-inflammatory conditions, including its pipeline product FMX114 for atopic dermatitis.
VYNE Therapeutics has completed the Phase 1b portion of its clinical trial for FMX114, a topical treatment for mild-to-moderate atopic dermatitis. The formulation combines tofacitinib and fingolimod, showing significantly lower systemic drug exposure compared to oral forms. The mean plasma Cmax of tofacitinib was reported as 50-fold and 1500-fold lower at Days 1 and 14, respectively. The study, initially set for 6 subjects, was amended to 4 due to early data. Encouraging results support progression to Phase 2a, with topline results expected in Q1 2022.
VYNE Therapeutics has sold its Molecule Stabilizing Technology (MST) franchise, including the topical minocycline products AMZEEQ and ZILXI, to Journey Medical Corporation for $25 million upfront payments and potential milestone payments of up to $450 million. This strategic move aligns with VYNE's focus on developing its immuno-inflammatory pipeline, which includes FMX114 and InhiBET™ platform candidates. The cash proceeds will help support operations throughout 2022, with expected critical data releases from ongoing studies.
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