VYNE

Company is progressing its previously initiated strategic review evaluating a range of options to maximize shareholder value, including assessment of internal pipeline opportunities and broader strategic alternatives 12-week, non-clinical toxicology study of VYN202 in dogs to remedy the partial hold in male clinical subjects is ongoing; Company continues to evaluate potential opportunities for VYN202 as a treatment for serious, immune-mediated diseases Cash runway into first half of 2027 based on previously announced cost reductions BRIDGEWATER, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat inflammatory and immune-mediated conditions with high unmet need, today reported financial results as of and for the quarter ended September 30, 2025, and provided a business update. “Consistent with our focus on growing shareholder value, we have made considerable progress in evaluating a number of potential value-creating opportunities as part of our strategic review process, and we look forward to providing an update on these efforts as soon as possible,” said David Domzalski, President and Chief Executive Officer of VYNE. “In parallel, we initiated a repeat 12-week, non-clinical toxicology study in dogs for VYN202. We believe a successful outcome from this study will enable us to remove the partial hold for testing VYN202 in male clinical subjects across a range of potential immuno-inflammatory diseases.” Business Updates In August 2025, VYNE’s Board of Directors initiated a strategic review to evaluate a range of options to maximize stockholder value, including the assessment of the Company’s internal pipeline, financing opportunities and strategic alternatives. These alternatives may include strategic partnerships, licensing opportunities, merger or acquisition transactions, asset sales or other potential paths. As part of this process, which remains ongoing, the Company is evaluating opportunities for VYN202, including as part of broader strategic alternatives. In conjunction, the Company implemented cost reductions that are expected to extend its cash runway into the first half of 2027. There can be no assurance that the process will result in any such transaction. VYNE’s Board of Directors has not set a time...

Explore VYNE Therapeutics's Fair Values from the Community and select yours Net loss: US$5.75m (loss narrowed by 39% from 2Q 2024). US$0.13 loss per share (improved from US$0.22 loss in 2Q 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 54%. Earnings per share (EPS) exceeded analyst estimates by 42%. Looking ahead, revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Performance of the American Pharmaceuticals industry. The company's shares are up 2.9% from a week ago. Don't forget that there may still be risks. For instance, we've identified 7 warning signs for VYNE Therapeutics (6 make us uncomfortable) you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Implemented cost reductions extend cash runway into first half of 2027 BRIDGEWATER, N.J., Aug. 14, 2025 (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 reported financial results as of and for the quarter ended June 30, 2025. The Company is actively evaluating opportunities to enhance the value of its pipeline programs. VYNE’s oral BD2-selective BET inhibitor, VYN202, has recently demonstrated a promising efficacy signal in a Phase 1b clinical trial in moderate to severe plaque psoriasis, as well as disease-modifying potential across multiple translational models of fibro-inflammatory disease and hematologic malignancies. These new data, in areas such as nephrology, pulmonology, rheumatology and myeloproliferative neoplasms, among others, underscore the therapeutic potential of the program. As previously announced, the Company is seeking a partner for its topical BET inhibitor, repibresib. “The strength of our recent clinical and preclinical findings for VYN202 provides a compelling scientific foundation as we determine the best path forward for the VYN202 program,” said David Domazalski, President and Chief Executive Officer of VYNE. “In conjunction, we have implemented cost reductions that are expected to extend our cash runway into the first half of 2027, giving us additional flexibility during this period.” Pipeline Overview VYN202, an oral small molecule BD2-selective BET inhibitor: Preclinical and translational data highlight disease-modifying potential of VYN202. VYNE has evaluated VYN202 in areas such as nephrology, pulmonology, rheumatology and myeloproliferative neoplasms, among others. These data, combined with the promising preliminary data from seven subjects enrolled in the Company’s Phase 1b trial in moderate-to-severe plaque psoriasis, support the potential of VYN202 as a potent, disease-modifying therapy for the treatment of serious, immune-mediated diseases and hematological cancers with limited effective treatment options. Phase 1b trial in subjects with moderate-to-severe plaque psoriasis. In April 2025, the U.S. Food and Drug Administration (FDA) verbally placed a clinical hold on the Company’s Phase 1b trial evaluating VYN20...

Trial Did Not Meet Primary Endpoint or Key Secondary Endpoint of F-VASI50 and F-VASI75 Nominally Statistically Significant Effects Observed in Key Secondary and Exploratory Endpoints of Change from Baseline in F-VASI and T-VASI at 3% Concentration Company Will Terminate Extension Phase of Trial and Seek External Partner for Continued Development of Repibresib BRIDGEWATER, N.J., July 30, 2025 (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 topline results from its Phase 2b trial evaluating Repibresib gel in nonsegmental vitiligo. The trial, which evaluated 177 subjects, did not meet its primary endpoint of the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (F-VASI50) at week 24 compared to vehicle. The trial also missed a key secondary endpoint of F-VASI75. However, the trial showed a nominally statistically significant treatment effect for the highest dose cohort in a key secondary endpoint, percent change-from-baseline (CFB) in F-VASI score at week 24 compared to vehicle (Repibresib 3%: -43.6% v. Vehicle: -25.6%), and an exploratory endpoint of percent CFB in T-VASI score at week 24 compared to vehicle (Repibresib 3%: -28.3% v. Vehicle: -16.2%). In evaluating the results of the trial, the Company believes the results were impacted by an unusually high vehicle effect and further impacted by a higher-than-expected dropout rate in the active arms of the trial relative to vehicle (Repibresib 3%: 36.6%; Repibresib 2%: 30.2%; Repibresib 1%: 26.1% and vehicle: 10.6%). Based on these data, the company will discontinue treatment in the ongoing extension phase of the trial and will terminate the trial. The Phase 2b trial was a randomized double-blind, vehicle-controlled, multi-center trial that evaluated the safety and efficacy of Repibresib dosed once daily (QD) at 1%, 2% and 3% concentrations, versus vehicle in 177 subjects (mITT population) with nonsegmental vitiligo. The trial was conducted at 45 sites in North America and assessed various efficacy endpoints, including the primary endpoint of the proportion of subjects achieving F-VASI50 at Week 24 versus vehicle, as well a...

Net loss: US$8.60m (loss widened by 38% from 1Q 2024). US$0.20 loss per share (further deteriorated from US$0.15 loss in 1Q 2024). Our free stock report includes 4 warning signs investors should be aware of before investing in VYNE Therapeutics. Read for free now. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates. Earnings per share (EPS) also surpassed analyst estimates by 31%. Looking ahead, revenue is forecast to grow 92% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Performance of the American Pharmaceuticals industry. The company's shares are down 5.1% from a week ago. We should say that we've discovered 4 warning signs for VYNE Therapeutics (2 make us uncomfortable!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Repibresib gel (VYN201) Phase 2b vitiligo top-line results expected in mid-2025 Expected cash runway into 2H 2026 BRIDGEWATER, N.J., May 08, 2025 (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 financial results as of and for the quarter ended March 31, 2025, and provided a business update. “During the first quarter of 2025, we continued to progress our Phase 2b trial evaluating repibresib for the treatment of vitiligo, and we anticipate reporting top-line results from this trial mid-year,” said David Domzalski, President and Chief Executive Officer of VYNE. “With only one FDA-approved therapy, vitiligo remains an area of significant unmet need, and we believe repibresib has the potential to become a highly differentiated and important therapy for addressing this large patient population. With respect to VYN202, we will continue to work closely with the FDA to address the clinical hold placed on our Phase 1b psoriasis trial, and we expect to provide additional updates as we gain concurrence on the necessary steps needed to move forward and lift the clinical hold.” Recent Pipeline and Corporate Updates Repibresib gel, a locally-administered small molecule pan-BD BET inhibitor (Phase 2b, nonsegmental vitiligo): Top-line results from the Phase 2b trial are expected in mid-2025. The fully enrolled, Phase 2b trial (NCT06493578) is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily repibresib gel in three dose cohorts (1%, 2% or 3% concentrations) compared to vehicle over 24 weeks in subjects with active or stable nonsegmental vitiligo. Subjects have been randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle (approximately 45 subjects in each arm). Top-line results from the 24-week double-blind, vehicle-controlled portion of the trial are expected mid-year. Following the 24-week treatment period, subjects who have been randomized in the three active dose cohorts will continue treatment with their respective dose concentrations for an additional 28-week active treatment extension. Subjects who have been randomized in the vehicle group during the initial...