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 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.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced that its President and CEO, David Domzalski, will present at Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference on December 8, 2022. The presentation titled Hit or Miss: Companies with 2023 Readouts & Launches to Keep in Focus will take place from 10:00 to 10:45 a.m. ET. VYNE focuses on innovative therapies for immuno-inflammatory conditions, leveraging its unique bromodomain & extra-terminal (BET) domain platform, including lead programs VYN201 and VYN202.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced participation in the Piper Sandler 34th Annual Healthcare Conference on December 1, 2022. CEO David Domzalski will present at 12:30 p.m. ET and management will host investor meetings on the same day. A webcast link is provided for those interested in attending, with a replay available for 90 days post-event. VYNE is focused on developing innovative therapies for immuno-inflammatory conditions, utilizing its proprietary BET domain platform, including lead programs VYN201 and VYN202.
VYNE Therapeutics has initiated a Phase 1a/b clinical trial for VYN201, a BET inhibitor targeting vitiligo treatment. The trial aims to establish safety and pharmacokinetics in healthy volunteers and assess early efficacy in vitiligo patients. Phase 1a involves up to 30 healthy participants, while Phase 1b will treat up to 30 diagnosed patients. Topline results are anticipated in the first half of 2023. VYN201 demonstrates promise in reducing skin pigment loss and has shown efficacy in preliminary studies, positioning it as a novel therapeutic option for vitiligo.
VYNE Therapeutics announced the receipt of IND clearance for its pan-BD BET inhibitor, VYN201, targeting vitiligo, with patient enrollment for a Phase 1a/b trial expected this month. The company is also advancing its oral BET inhibitor program, VYN202, in collaboration with Tay Therapeutics. Additionally, analysis of the FMX114 Phase 2a trial indicates potential efficacy for moderate-to-severe atopic dermatitis, despite initial statistical insignificance at week 4. Financially, VYNE reported a net loss of $9.5 million for Q3 2022, a decrease from $21.3 million in Q3 2021.
VYNE Therapeutics announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022. CEO David Domzalski will present at 12:30 p.m. ET and is available for one-on-one meetings with investors. VYNE focuses on innovative therapies for immuno-inflammatory conditions using its unique bromodomain and extra-terminal domain platform, including lead programs VYN201 and VYN202. A replay of the presentation will be accessible on VYNE's website for 90 days.
VYNE Therapeutics Inc. (VYNE) reported its financial results for the second quarter and first half of 2022. For Q2, the company posted a net loss of $8.5 million, significantly down from $19.9 million in Q2 2021. Revenues fell to $0.1 million compared to $0.3 million the previous year, primarily from royalty revenue. Research and development expenses decreased by 18.6% to $4.1 million, while selling, general, and administrative expenses declined by 10.1% to $4.3 million. VYNE has $42.8 million in cash reserves, expected to fund operations into Q3 2023.
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