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 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.
VYNE Therapeutics announced its novel ZILXI™ (minocycline) topical foam has gained coverage from Express Scripts, effective October 2, 2020. The FDA approved ZILXI in May 2020, making it the first minocycline product for treating rosacea in adults. The annual cost of ZILXI is $485 per 30-gram canister. This coverage represents access for millions of patients in the U.S. and is a significant milestone for VYNE, enhancing treatment options for those with rosacea.
VYNE Therapeutics announced that its FDA-approved ZILXI (minocycline) topical foam, 1.5%, will be covered by Express Scripts effective October 2, 2020. This coverage will expand access to millions of additional patients in the U.S. ZILXI is the first minocycline product approved for treating inflammatory lesions of rosacea in adults. The annual list price is $485 per 30-gram canister. The company emphasizes ZILXI's innovative formulation, which minimizes systemic side effects by delivering the medication in a topical form, leveraging its proprietary Molecule Stabilizing Technology (MST™).
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced the availability of its new product, ZILXI™ (minocycline) topical foam, 1.5%, for treating inflammatory lesions of rosacea, starting October 1, 2020. This is the first minocycline product approved by the FDA for rosacea. ZILXI is priced at $485 per 30-gram canister and the company aims to ensure broad patient access through commercial insurer contracts. VYNE is employing a multi-channel marketing strategy and utilizing their sales force to target rosacea physicians effectively.
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