Promising results support VYN202’s potential as a novel, once-daily oral treatment for a broad range of immune-mediated disorders Consistent with Phase 1a SAD results, VYN202 demonstrated a favorable safety and tolerability profile with no drug-related adverse events historically associated with earlier generation, less selective BET inhibitors VYN202 demonstrated robust pharmacodynamic activity including evidence of target... Read More

VYN201 Phase 2b vitiligo trial exceeds enrollment target; Expected to be fully enrolled in December 2024 with top-line results on track for mid-2025 Reported positive first-in-human Phase 1a SAD data for VYN202, with MAD data expected in Q4 2024 BRIDGEWATER, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing... Read More

VYN202 was generally well tolerated with no drug-related adverse events Pharmacokinetic results demonstrated dose-dependent exposure of VYN202 in blood Pharmacodynamic activity observed on target engagement and inflammatory biomarkers Dosing has begun in the MAD portion of the trial with results expected in Q4 2024 BRIDGEWATER, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the... Read More

BRIDGEWATER, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced that management will participate in two investor conferences in September: H.C. Wainwright 26th Annual Global Investment... Read More

Initiated Phase 2b trial of VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025 Phase 1a SAD/MAD trial of VYN202 progressing, with data from the SAD and MAD portions expected in Q3 and Q4 2024, respectively Balance sheet expected to fund key clinical milestones for VYN201 and VYN202 through the end of 2025 BRIDGEWATER, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE)... Read More

BRIDGEWATER, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced GB Patent No. 2621505 entitled “Pyrrolopyridone derivatives useful in the treatment of inflammatory disorders, immune disorders and... Read More

BRIDGEWATER, N.J., July 09, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced the appointment of Subhashis Banerjee, M.D., as Senior Vice President of Clinical Development, effective as of July 8, 2024. Dr.... Read More

BRIDGEWATER, N.J., June 26, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced members of VYNE’s management will participate in one-on-one meetings at the Leerink Partners Therapeutics Forum on Immunology and... Read More

VYN202 has been designed to achieve class-leading potency and BD2-selectivity Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 in healthy volunteers; top-line data expected in 2H’24 BRIDGEWATER, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and... Read More

Trial will evaluate once-daily VYN201 gel in subjects with either active or stable nonsegmental vitiligo Top-line data from the 24-week double-blind portion of the trial expected in mid-2025 BRIDGEWATER, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the... Read More

Design of Phase 2b trial for VYN201 in nonsegmental vitiligo finalized and on track to begin this quarter Phase 2b trial expected to enroll approximately 160 subjects with either active or stable nonsegmental vitiligo and will evaluate VYN201 gel in 1%, 2% and 3% concentrations compared to vehicle for 24 weeks, followed by a 28-week active treatment extension IND clearance received for oral BD2-selective BET inhibitor,... Read More

In preclinical studies, VYN202 achieved consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity across a variety of inflammatory and fibrotic models Phase 1a SAD/MAD trial expected to start this quarter BRIDGEWATER, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing... Read More

Presentations will highlight positive preclinical and Phase 1b data of novel BET inhibitor, VYN201, in nonsegmental vitiligo BRIDGEWATER, N.J., May 01, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced two... Read More

BRIDGEWATER, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that David Domzalski, President and Chief Executive Officer, and Dr. Iain Stuart, Chief Scientific Officer, will... Read More

2023 was a transformative year for VYNE, marked by the achievement of clinical proof-of-concept for VYN201 in vitiligo and a successful financing with a syndicate of leading institutional investors Anticipate commencing a Phase 2b trial for VYN201 and a Phase 1a trial for VYN202 in Q2 2024 Ended 2023 with $93.3 million of cash, cash equivalents, restricted cash and marketable securities, providing runway through the end of... Read More

Oral presentation on March 7, 2024 will review positive safety and efficacy data for novel BET inhibitor VYN201 BRIDGEWATER, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that Dr. Iain Stuart,... Read More

BRIDGEWATER, N.J., Feb. 21, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that David Domzalski, President and Chief Executive Officer, will participate in a fireside chat at the TD Cowen 44 th Annual Health... Read More

VYN201 demonstrated positive effect on key biomarkers relevant to vitiligo Data supports VYN201’s rapid onset of action and previously announced positive clinical results Program is on track for Phase 2b initiation in Q2 BRIDGEWATER, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and... Read More

BRIDGEWATER, N.J., Jan. 03, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced the appointment of Christine Borowski, Ph.D., to its board of directors, effective as of January 1, 2024. “We are pleased to welcome... Read More

Transformative capital raise of $88.2 million from leading healthcare investors provides funding for BET inhibitor programs through the end of 2025 Phase 2b preparatory activities progressing for VYN201 in nonsegmental vitiligo following positive Phase 1b results On track for VYN202 IND submission by year-end 2023, with plans to begin Phase 1a trial in Q1 2024 BRIDGEWATER, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- VYNE... Read More

Event will highlight VYN201 Phase 1b trial results, VYN202 preclinical data and VYNE’s clinical development plans Program to feature KOL presentation covering unmet need and current treatment landscape in vitiligo BRIDGEWATER, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated... Read More

BRIDGEWATER, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced the closing of its previously announced private placement financing (the “PIPE”). In the PIPE, VYNE received aggregate gross proceeds... Read More

Treatment with VYN202 resulted in significant inhibition of key inflammatory biomarkers and substantial resolution of the signs and symptoms of psoriasis and rheumatoid arthritis Following completion of recent financing, VYNE expects to initiate a Phase 1a SAD/MAD clinical trial in Q1 2024, followed by Phase 1b trials in moderate-to-severe plaque psoriasis and in moderate-to-severe adult-onset rheumatoid arthritis in the... Read More

BRIDGEWATER, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the Company has signed a securities purchase agreement with certain healthcare-focused institutional investors for a private... Read More

Clinical proof-of-concept achieved with statistically significant dose dependent reduction in F-VASI score from baseline for the VYN201 1.0% and 2.0% cohorts compared to the 0.5% cohort VYN201 was generally well-tolerated with no clinically relevant treatment emergent adverse events across all dose cohorts Clinical response and rapid onset of action suggest VYN201 has the potential to be the category leader in the treatment... Read More

BRIDGEWATER, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that David Domzalski, President and Chief Executive Officer, will participate in the H.C. Wainwright 25th Annual Global... Read More

Anticipate announcing preliminary Phase 1b safety and efficacy data for pan-BD BET inhibitor, VYN201, in nonsegmental vitiligo in Q3 2023 IND-enabling studies for VYN202, a potential best-in-class oral small molecule BD2-selective BET inhibitor, are ongoing in anticipation of indication selection in Q4 2023 and initiating a Phase 1 trial in Q1 2024 BRIDGEWATER, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc.... Read More

BRIDGEWATER, N.J., May 18, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that members of management will attend the Biotechnology Innovation Organization (BIO) International Convention, taking... Read More

Anticipate topline 16-week data for all three cohorts from the Phase 1b trial for pan-BD BET inhibitor, VYN201, in nonsegmental vitiligo in the third quarter of 2023 IND-enabling studies for VYN202, a potential best-in-class oral small molecule BD2-selective BET inhibitor, are ongoing in anticipation of an IND filing by year-end 2023 BRIDGEWATER, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE)... Read More

Preclinical studies suggest VYN202 has the potential to be the most potent and selective BET inhibitor in development VYN202 has demonstrated a potent anti-inflammatory and anti-fibrotic effect in multiple validated preclinical models of autoimmune disease IND-enabling studies are ongoing in anticipation of an IND filing by year-end BRIDGEWATER, N.J., May 01, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE)... Read More

VYN201 at the 0.5 mg/ml and 1 mg/ml doses demonstrated statistically significant reductions in lung fibrosis and hydroxyproline levels compared to placebo Reduction in lung fibrosis from VYN201 treatment resulted in significant improvements in blood oxygen saturation and functional lung volume Data further supports potential broad utility of VYN201 as a potent locally-administered anti-inflammatory and anti-fibrotic molecule... Read More

No quantifiable VYN201 plasma concentrations above the assay lower limit of quantification supports “soft” drug approach for topical pan-BD BET inhibitor All hematological parameters, including platelet counts, were within normal ranges, a finding which has not previously been observed with systemically administered pan-BD BET inhibitors Topline Phase 1b results in patients with nonsegmental vitiligo expected in mid-2023... Read More

BRIDGEWATER, N.J., March 22, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that David Domzalski, President and Chief Executive Officer, and Dr. Iain Stuart, Chief Scientific Officer, will... Read More

First vitiligo patients being treated with pan-BD BET inhibitor, VYN201, for up to 16 weeks in Phase 1b clinical trial Anticipate topline Phase 1b data in mid-2023 BRIDGEWATER, N.J., March 09, 2023 (GLOBE NEWSWIRE) - - VYNE Therapeutics Inc. ( Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of... Read More

BRIDGEWATER, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that it received a notification letter (the "Notification Letter on Compliance") from the Listing Qualifications Department... Read More

BRIDGEWATER, N.J., Feb. 22, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that David Domzalski, President and Chief Executive Officer, will participate in a fireside chat at the 43 rd Annual Cowen Health... Read More

VYN201 was generally well-tolerated with no clinically relevant treatment emergent adverse events from all dose cohorts, meeting the primary objective of the study Topline Phase 1b results in vitiligo patients expected in mid-2023 BRIDGEWATER, N.J., Feb. 15, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and... Read More

BRIDGEWATER, N.J., Feb. 10, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that its Board of Directors has approved a reverse stock split of the Company’s common stock at a ratio of 1-for-18. The reverse stock split was... Read More

First patient dosed follows swiftly from IND clearance and enrollment of first healthy volunteers in Phase 1a portion of study in November Topline data expected in 1H 2023 BRIDGEWATER, N.J., Jan. 09, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory... Read More

BRIDGEWATER, N.J., Dec. 07, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that GB Patent No. 2597228 entitled “ Compounds Comprising N-Methyl-2-Pyridone, And Pharmaceutically Acceptable Salts ” has been granted by the... Read More