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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 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.
VYNE Therapeutics reported financial results for Q4 and the full year of 2020, showing revenues of $21 million, up from $0.4 million in 2019. The company's net loss was $255.6 million, driven by significant expenses from R&D and impairments. VYNE launched its topical products ZILXI and AMZEEQ, gaining market traction in acne and rosacea. Key developments include plans for a Phase 3 trial for FCD105 and a Phase 2a study for FMX114 targeting atopic dermatitis, expected to yield results by year-end. The company has sufficient cash to fund operations through 2022.
VYNE Therapeutics Inc. announced that CEO David Domzalski will present at the Cowen 41st Annual Health Care Conference on March 2, 2021, at 2:10 PM ET. The presentation will be in a fireside chat format, providing insights into the company's innovative therapies in dermatology, including AMZEEQ® and ZILXI®, both FDA-approved minocycline products. For those interested, the webcast link is here. VYNE aims to enhance the lives of patients through proprietary therapies.
VYNE Therapeutics announced promising preclinical data for FMX114, a topical gel designed to treat mild-to-moderate atopic dermatitis (AD). The Phase 2a clinical study is set to begin in the third quarter of 2021, with top-line results expected by year-end. In animal studies, FMX114 demonstrated an 89% reduction in the modified atopic dermatitis index score compared to control. VYNE plans to discuss further details during the year-end earnings call on March 4, 2021.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will report its financial results for the year ended December 31, 2020, on March 4, 2021, before market opening. The company will host a conference call at 8:30 a.m. ET to discuss the results and provide a corporate update. VYNE focuses on developing innovative dermatological therapies and has FDA approval for AMZEEQ and ZILXI, both minocycline topical products for acne and rosacea, respectively. This announcement indicates VYNE's ongoing commitment to transparency and communication with investors.
VYNE Therapeutics has announced a 1-for-4 reverse stock split effective February 16, 2021, to consolidate its shares from approximately 205 million to about 51 million. This move aims to align its share count with companies of similar market capitalizations. Stockholders will receive cash for any fractional shares following the split. The reverse stock split was earlier approved by stockholders at the Annual Meeting on August 3, 2020. The company's trading symbol will remain VYNE, and the new CUSIP number will be 92941V 209.
VYNE Therapeutics announced FDA approval for a label update of AMZEEQ® (minocycline) topical foam, which confirms a low propensity for P. acnes to develop resistance to minocycline. This update is significant for treating inflammatory lesions of moderate to severe acne in patients aged 9 and older. The label states spontaneous mutation frequencies for resistance are less than 1 in 100 million. CEO David Domzalski emphasized this information aids dermatologists in antibiotic choices, while the update is backed by a comprehensive antimicrobial characterization program.