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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 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.
VYNE Therapeutics Inc. reported disappointing results from the Phase 2a trial of FMX114 for treating mild-to-moderate atopic dermatitis, failing to meet its primary endpoint. In this study involving 21 patients, FMX114 showed a mean reduction of 60.62% in the Atopic Dermatitis Severity Index (ADSI) compared to 51.32% for the vehicle control (p=0.228). VYNE has approximately $43 million in cash and is set to receive a $5 million payment in January 2023. The management will review the trial data and reassess the company’s pipeline strategy moving forward.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced that Chief Scientific Officer Iain Stuart, Ph.D., will present at the B&T Cell-Mediated Autoimmune Disease Drug Development Conference on July 27, 2022. The presentation, titled The InhiBET™ Platform: Bromodomain and End Terminal (BET) Inhibitors in Autoimmune Disease, will focus on harnessing autoantibody signatures. VYNE is developing innovative therapies for immuno-inflammatory conditions, including its proprietary treatments like FMX114 for atopic dermatitis and a library of BET domain inhibitors.
VYNE Therapeutics has completed patient enrollment for the Phase 2a clinical study of FMX114, focusing on treating mild-to-moderate atopic dermatitis. FMX114 is a novel gel combining tofacitinib and fingolimod. Earlier findings from a Phase 1b trial indicated significant improvements in the Atopic Dermatitis Severity Index and reduced itch. VYNE anticipates releasing top-line efficacy results within 6 to 8 weeks, emphasizing advancements despite challenges from the COVID-19 pandemic.
VYNE Therapeutics will present at the HC Wainwright & Co. Global Investment Conference on May 25, 2022, featuring CEO David Domzalski and CSO Dr. Iain Stuart. The presentation is scheduled for 9:00 a.m. ET and will be available via webcast. VYNE focuses on developing innovative therapies for immuno-inflammatory conditions, notably FMX114 for atopic dermatitis and VYN201 and VYN202 for BET inhibitors.
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