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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. announced promising preclinical results for its BET inhibitor, VYN201, in treating vitiligo, an autoimmune skin disorder. The 0.1% and 1% concentrations of VYN201 significantly reduced melanocyte loss and pro-inflammatory biomarkers, outperforming the active control, ruxolitinib cream. Specifically, VYN201 demonstrated a 94.7% reduction in MMP-9 secretion and a 10-fold increase in melanin levels compared to the vehicle treatment. The company plans to advance VYN201 into human clinical trials later this year.
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced that CEO David Domzalski will participate in a virtual fireside chat at the 42nd Annual Cowen Healthcare Conference on March 8, 2022, at 12:50 p.m. ET. The conference will provide an opportunity for investors to engage in 1-on-1 meetings with management. A webcast of the presentation is accessible via the provided link, and a replay will be available on the VYNE website for 90 days post-event. VYNE focuses on developing innovative therapies for immuno-inflammatory conditions, including its pipeline product FMX114 for atopic dermatitis.
VYNE Therapeutics has completed the Phase 1b portion of its clinical trial for FMX114, a topical treatment for mild-to-moderate atopic dermatitis. The formulation combines tofacitinib and fingolimod, showing significantly lower systemic drug exposure compared to oral forms. The mean plasma Cmax of tofacitinib was reported as 50-fold and 1500-fold lower at Days 1 and 14, respectively. The study, initially set for 6 subjects, was amended to 4 due to early data. Encouraging results support progression to Phase 2a, with topline results expected in Q1 2022.
VYNE Therapeutics has sold its Molecule Stabilizing Technology (MST) franchise, including the topical minocycline products AMZEEQ and ZILXI, to Journey Medical Corporation for $25 million upfront payments and potential milestone payments of up to $450 million. This strategic move aligns with VYNE's focus on developing its immuno-inflammatory pipeline, which includes FMX114 and InhiBET™ platform candidates. The cash proceeds will help support operations throughout 2022, with expected critical data releases from ongoing studies.
VYNE Therapeutics announced its participation in one-on-one investor meetings at the LifeSci Partners 11th Annual Corporate Access Event, scheduled virtually from January 5-7, 2022. The Company aims to enhance patient care through innovative therapies targeting immuno-inflammatory conditions. Key products include FMX114 for mild-to-moderate atopic dermatitis and a range of BET domain inhibitors for various conditions. Investors are encouraged to visit VYNE's website for further updates and disclosures.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will participate in the Piper Sandler 33rd Annual Virtual Healthcare Conference, with CEO David Domzalski presenting a pre-recorded fireside chat available on the Company’s website starting November 22, 2021. The chat will commence at 10:00 a.m. Eastern Time. Additionally, VYNE management will hold 1-on-1 meetings with investors during the conference, scheduled from November 29 to December 2.
VYNE aims to develop innovative therapies for immuno-inflammatory conditions and rare skin diseases.
VYNE Therapeutics reported Q3 2021 revenues of $4.1 million, a rise from $3.3 million in Q3 2020, driven mainly by product sales. The company posted a net loss of $21.3 million, reducing from $24.7 million year-over-year. VYN201, the lead BET inhibitor candidate, showed significant promise in preclinical studies, reducing key pro-inflammatory cytokines and improving skin repair. VYNE expects to enter clinical trials for VYN201 in 2022 and anticipates Phase 2a results for FMX114 in early Q1 2022. The divestment process for its topical minocycline franchise is advancing successfully.
VYNE Therapeutics announced promising preclinical data for its BET inhibitor, VYN201, in treating autoimmune skin diseases. The study on hairless mice showed VYN201 significantly improved skin healing, reducing lesion severity scores and healing time compared to negative controls. Lesions treated with VYN201 healed in a mean time of 15.5 days versus 21 days for controls. Additionally, VYN201 treatment led to less fibrotic tissue, resulting in enhanced scar appearance. These results support the continued development of VYN201, aiming to address significant unmet medical needs in skin diseases.
VYNE Therapeutics Inc. (Nasdaq: VYNE) will announce its third-quarter financial results for the period ending September 30, 2021, on November 10, 2021, before market opening. A conference call and webcast will take place at 8:30 AM ET to discuss the results and provide updates on corporate developments. VYNE aims to improve patient lives through innovative therapies for immuno-inflammatory conditions and has a pipeline including FMX114 for atopic dermatitis.
VYNE Therapeutics Inc. announced promising preclinical data for its BET inhibitor, VYN201, demonstrating significant reductions in pro-inflammatory cytokines linked to Th17-mediated autoimmune diseases. In a murine model, a 0.1% dose of VYN201 achieved a 94% reduction in inflammation severity compared to vehicle controls, showing efficacy similar to a super-potent glucocorticosteroid. Furthermore, VYN201 exhibited better tolerance than clobetasol propionate, with treated mice showing normal weight gain. The compound also outperformed the JAK1/2 inhibitor ruxolitinib in ex vivo human skin tissue studies.