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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 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.
VYNE Therapeutics announced that Dr. Iain Stuart will moderate a scientific panel discussion at the 2nd Annual JAK Inhibitors Drug Development Digital Event, occurring from June 29 to July 1, 2021. The discussion, set for June 30 at 2:40 PM Eastern Time, will focus on combinational opportunities with JAK inhibitors and ongoing research trends in immunology. The event aims to address the lack of JAK inhibitors in specific disease profiles and explore the potential benefits of combination therapeutic approaches.
VYNE Therapeutics announced its Q1 2021 financial results, reporting revenues of $4.1 million, a significant increase from $1.8 million in Q1 2020, primarily driven by the launches of AMZEEQ and ZILXI. The net loss narrowed to $20.6 million compared to $40.2 million in the prior year. VYNE plans to initiate a Phase 2a study for FMX114, a new treatment for atopic dermatitis, in Q3 2021. The company also raised $73.1 million through a stock offering and executed a 1-for-4 reverse stock split, strengthening its cash position to $120.4 million.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced it will report its financial results for Q1 2021 on May 6, 2021, before market opens. A conference call will follow at 8:30 a.m. ET to discuss these results and provide a corporate update. VYNE focuses on developing innovative dermatological therapies, having received FDA approvals for AMZEEQ® and ZILXI®. Investors can access a replay of the call on VYNE's website post-event.
VYNE Therapeutics announced that CEO David Domzalski will present at the Barclays Global Healthcare Conference and H.C. Wainwright Global Life Sciences Conference on March 9, 2021. The Barclays conference will include a fireside chat at 8:00 AM Eastern Time, with a webcast available at this link. The H.C. Wainwright conference will be available on demand starting at 7:00 AM Eastern Time on the same day, with a webcast link at this link.
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