VYNE Therapeutics Inc. (VYNE)

VYNE Therapeutics Inc. (VYNE) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to a loss of $0.22 per share a year ago.

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.

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.

BRIDGEWATER, N.J., July 02, 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 provided a program update for VYN202 following the clinical hold issued by the U.S. Food and Drug Administration (FDA) in April for the Company's Phase 1b clinical trial in the treatment of moderate-to-severe plaque psoriasis. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immune-mediated diseases.

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.

The U.S. Food and Drug Administration (FDA) on Friday verbally informed that it placed a clinical hold on VYNE Therapeutics Inc.'s VYNE Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis.

BRIDGEWATER, N.J., April 25, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company's Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis. The clinical hold determination was made following a recent observation of testicular toxicity in dogs from a non-clinical toxicology study with VYN202.

BRIDGEWATER, N.J., March 20, 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 that VYNE's management will participate in the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference (Skin Diseases, Conditions and Disorders) being held on Thursday, March 27, 2025.

Repibresib gel (VYN201) Phase 2b vitiligo top-line results expected in mid-2025 VYN202 Phase 1b psoriasis trial initiated with results anticipated by year-end 2025 Expected cash runway into 2H 2026 BRIDGEWATER, N.J., March 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 chronic inflammatory and immune-mediated conditions with high unmet need, today announced financial results as of and for the fourth quarter and year ended December 31, 2024, and provided a business update.

BRIDGEWATER, N.J., Feb. 20, 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 that VYNE's management will participate in two investor conferences in March.

BRIDGEWATER, N.J., Feb. 19, 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 that the first subject has been dosed in a Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immune-mediated diseases. The Phase 1b trial will primarily evaluate the safety of VYN202, administered orally once a day for 12 weeks, with secondary objectives to evaluate the pharmacokinetic profile and preliminary evidence of efficacy, including improvement from baseline in psoriasis area and severity index (PASI) scores. Top-line data from the 12-week randomized, placebo-controlled trial are expected by year-end 2025.

BRIDGEWATER, N.J., Jan. 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 chronic inflammatory and immune-mediated conditions with high unmet need, today announced completion of enrollment in the Phase 2b trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.

BRIDGEWATER, N.J., Dec. 23, 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 positive results from the multiple ascending dose (“MAD”) portion of its Phase 1a SAD/MAD trial of VYN202. The Phase 1a trial was a two-part, double-blind, placebo-controlled dose-escalation study in healthy volunteers consisting of single ascending dose (“SAD”) and MAD components to evaluate the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics of VYN202.

VYNE Therapeutics Inc. (VYNE) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.24. This compares to loss of $1.85 per share a year ago.

BRIDGEWATER, N.J., Sept. 12, 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 positive data from the single ascending dose (“SAD”) portion of its ongoing Phase 1a trial of VYN202. The Phase 1a trial is a two-part, double-blind, placebo-controlled dose-escalation study in healthy volunteers consisting of SAD and multiple ascending dose (“MAD”) components to evaluate the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics of VYN202. Findings from the SAD portion of the Phase 1a trial to date are as follows:

VYNE Therapeutics Inc. (VYNE) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $3.08 per share a year ago.