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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 announced positive results from the Phase 1a trial of its investigational BET inhibitor, VYN201, designed for topical administration. Key findings reveal no quantifiable plasma concentrations of VYN201, which supports its 'soft' drug approach. Furthermore, all hematological parameters, including platelet counts, remained within normal ranges, a significant improvement compared to systemically administered BET inhibitors. The trial enrolled 30 healthy volunteers and demonstrated no serious adverse events. The Phase 1b results, focusing on patients with nonsegmental vitiligo, are expected in mid-2023, potentially marking a new treatment avenue in this therapeutic area.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced participation in the H.C. Wainwright Autoimmune & Inflammation Disease Virtual Conference on March 30, 2023. CEO David Domzalski and Chief Scientific Officer Dr. Iain Stuart will engage in a fireside chat at 3:30 PM ET. Investors can also schedule 1-on-1 meetings during the event. The discussion will cover the company’s innovative therapies for immuno-inflammatory conditions, including their lead programs, VYN201 and VYN202. A replay of the webcast will be available on the company's website for 90 days post-conference. For details, visit vynetherapeutics.com.
VYNE Therapeutics reported progress in the clinical development of VYN201, a pan-BD BET inhibitor, for treating vitiligo. The Phase 1b trial is underway, with topline data anticipated in mid-2023. Preliminary Phase 1a results indicated no serious adverse events, allowing dose selection for the trial. VYNE's 2022 financial results showed a net loss of $23.2 million, significantly down from $73.3 million in 2021. Revenue declined to $0.5 million from $0.9 million. The company had $31.0 million in cash as of December 31, 2022, sufficient to fund operations into Q4 2023.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced on February 28, 2023, that it has regained compliance with Nasdaq's minimum bid price requirement. The company received a Notification Letter indicating that its common stock's closing bid price was at $1.00 per share or greater for the last 10 consecutive business days, from February 13 to February 27, 2023. VYNE is focused on developing innovative therapies for immuno-inflammatory conditions, utilizing its proprietary bromodomain & extra-terminal (BET) domain platform, which includes lead programs VYN201 and VYN202.
VYNE Therapeutics Inc. (Nasdaq: VYNE), a clinical-stage biopharmaceutical company, announced that CEO David Domzalski will participate in a fireside chat at the 43rd Annual Cowen Health Care Conference on March 7, 2023. The event will take place at 2:10 PM ET at the Boston Marriott Copley Place, where management will also hold 1-on-1 meetings with investors. A webcast link is provided for attendees to view the session online. The webcast replay will be accessible for 90 days post-conference. VYNE is focused on developing therapies for immuno-inflammatory conditions through its proprietary bromodomain & extra-terminal (BET) domain platform.
VYNE Therapeutics announced positive results from the Phase 1a trial of VYN201, a novel BET inhibitor for treating vitiligo. The study involved 30 healthy volunteers who received topically applied doses without any serious adverse events, confirming safety and tolerability. Key findings include no clinically relevant treatment emergent adverse events and no withdrawals from the trial. VYNE plans to evaluate selected doses in the ongoing Phase 1b trial involving non-segmental vitiligo patients, with results expected in mid-2023. The company aims to advance its BET inhibitor program as a differentiated therapy with promising efficacy and safety.
VYNE Therapeutics Inc. announced a 1-for-18 reverse stock split effective after market close on February 10, 2023. This move aims to help the company comply with the $1.00 minimum bid price standard for continued listing on the Nasdaq Capital Market. Following the split, approximately 3,251,871 shares will be outstanding, down from 58,533,691. The decision was endorsed by shareholders on January 12, 2023. All stockholders will see their shares adjusted automatically, and those with fractional shares will receive cash compensation. VYNE continues to focus on developing therapies for immuno-inflammatory conditions.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced the dosing of the first vitiligo patient in its Phase 1a/b clinical trial for VYN201, a pan-BET inhibitor aimed at treating immuno-inflammatory conditions. This milestone follows IND clearance and enrollment of healthy volunteers. The trial is designed to assess safety and pharmacokinetic data (Phase 1a) and early clinical proof-of-concept in vitiligo patients (Phase 1b), with topline data expected in the first half of 2023. Vitiligo affects 0.5-2% of the global population, with limited treatment options currently available.
VYNE Therapeutics Inc. (Nasdaq: VYNE) is set to participate in the LifeSci Partners 12th Annual Corporate Access Event during the J.P. Morgan Healthcare Conference in San Francisco, CA. Scheduled for January 10-11, 2023, the company will conduct one-on-one meetings at the Beacon Grand Hotel.
VYNE focuses on developing innovative therapies for immuno-inflammatory conditions, utilizing its proprietary bromodomain & extra-terminal (BET) domain platform, which includes lead programs VYN201 and VYN202.
VYNE Therapeutics has announced the granting of a new patent (GB Patent No. 2597228) for its VYN201 program by the UK’s Intellectual Property Office, expiring in April 2040. This patent, derived from a PCT application filed by The University of Dundee, supports VYNE's ongoing development of its pan-BET inhibitor, VYN201, currently in a Phase 1a/b clinical trial for vitiligo. The company anticipates further patent approvals and believes VYN201 could offer broad therapeutic utility across various inflammatory conditions.
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