Vyne Therapeutics Inc Stock Price, News & Analysis

VYNE Therapeutics Inc. announced promising results from the Phase 1b segment of their Phase 1b/2a clinical trial for FMX114, a gel for treating mild-to-moderate atopic dermatitis (AD). At week 2, FMX114 showed a significant reduction in the Atopic Dermatitis Severity Index (ADSI) score, with an 81.4% mean reduction compared to 54.3% for the vehicle. Additionally, a 96.4% mean reduction in itch severity was reported. The Phase 2a results are anticipated in Q2 2022, with FMX114 positioning to be a first-in-class topical treatment.

VYNE Therapeutics announced positive preclinical results for VYN201, a pan-BET inhibitor, in an animal model of rheumatoid arthritis. The study showed statistically significant improvements in treatment response at 1mg/kg and 10mg/kg doses, surpassing the leading steroid, dexamethasone, in reducing inflammation. VYN201's potential for broad therapeutic applications was emphasized, supported by a planned initiation of first-in-human clinical trials in the second half of 2022.

VYNE Therapeutics reported Q4 and full-year 2021 financial results, showing revenues of $14.8 million, down from $21.0 million in 2020. The net loss narrowed to $73.3 million, or $1.42 per share, compared to a loss of $255.6 million, or $7.88 per share, in the previous year. The company highlighted progress in its immuno-inflammatory pipeline, including positive Phase 1b data for FMX114. VYNE expects to present Phase 2a results for FMX114 and initiate its first human study for VYN201 in 2022, aiming to enhance shareholder value.

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 C_max 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.