Vyne Therapeutics Inc - VYNE STOCK NEWS

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.

VYNE Therapeutics Inc. (Nasdaq: VYNE) will report its financial results for Q2 2021 on August 12, 2021, before the market opens. A conference call is scheduled for 8:30 a.m. ET to discuss these results and provide a corporate update. VYNE focuses on developing innovative therapies, including FDA-approved products AMZEEQ® and ZILXI®, utilizing its proprietary Molecule Stabilizing Technology (MST™). For further details, visit their website or follow their upcoming call.

VYNE Therapeutics Inc. has initiated a clinical trial for AMZEEQ (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne. Conducted at the Austin Institute for Clinical Research, the trial aims to assess safety, efficacy, and tolerability over a 20-week treatment period. The study will also evaluate AMZEEQ's impact on common adverse reactions of isotretinoin. Approximately 30 patients will be enrolled. AMZEEQ already has FDA approval for treating inflammatory lesions of acne vulgaris.