Welcome to our dedicated page for Vyne Therapeutics news (Ticker: VYNE), a resource for investors and traders seeking the latest updates and insights on Vyne Therapeutics stock.
Vyne Therapeutics Inc. (VYNE) is a clinical-stage biopharmaceutical company pioneering novel therapies for immuno-inflammatory conditions and dermatologic disorders. This dedicated news hub provides investors and industry professionals with timely updates on Vyne's clinical trials, regulatory milestones, and scientific advancements.
Access authoritative information on Vyne's BET inhibitor pipeline, including BD2-selective candidates like VYN201 (topical) and VYN202 (oral), designed to address chronic inflammatory diseases with improved safety profiles. Our curated news collection covers essential developments across preclinical research, FDA communications, and strategic partnerships.
Key updates include progress in treating conditions such as prurigo nodularis, vitiligo, and atopic dermatitis through Vyne's proprietary InhiBET platform. Bookmark this page for real-time notifications on Phase 2 trial results, intellectual property developments, and analyses of Vyne's position within the dermatology therapeutics market.
VYNE Therapeutics (Nasdaq: VYNE) announced that the FDA has placed a clinical hold on its Phase 1b study of VYN202 for moderate-to-severe plaque psoriasis treatment. The hold follows the discovery of testicular toxicity in dogs during non-clinical toxicology studies.
The company has suspended all screening, enrollment, and patient dosing for the VYN202 trial. While no serious adverse events have been reported in enrolled subjects, VYNE will work with the FDA to resolve the clinical hold.
Importantly, the clinical hold does not affect VYNE's ongoing Phase 2b trial of repibresib gel in nonsegmental vitiligo, which is a distinct compound from VYN202. Top-line results from the 24-week double-blind, vehicle-controlled portion of this trial are expected mid-year.
VYNE Therapeutics (Nasdaq: VYNE), a clinical-stage biopharmaceutical company specializing in developing therapies for chronic inflammatory and immune mediated conditions, has announced its participation in the upcoming H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference.
The conference, focusing on Skin Diseases, Conditions and Disorders, is scheduled for Thursday, March 27, 2025. Following the presentation, a webcast replay will be accessible on the VYNE website for a period of 90 days.
VYNE Therapeutics has reported its Q4 and full-year 2024 financial results, highlighting significant progress in its clinical pipeline. The company's key developments include:
The completion of enrollment in the Phase 2b trial of repibresib gel (VYN201) for nonsegmental vitiligo, with top-line results expected in mid-2025. The trial evaluates three dose cohorts (1%, 2%, 3%) against vehicle control in approximately 180 subjects.
Additionally, VYNE initiated a Phase 1b trial of VYN202, their oral BD2-selective BET inhibitor, for moderate-to-severe plaque psoriasis, with results anticipated by year-end 2025.
Financial highlights include:
- Cash position of $61.5 million as of December 31, 2024
- Expected runway into second half of 2026
- 2024 revenue of $0.5 million
- Net loss of $39.8 million ($0.93 per share)
- R&D expenses increased to $30.9 million from $16.3 million in 2023
VYNE Therapeutics (Nasdaq: VYNE), a clinical-stage biopharmaceutical company, has announced its management team's upcoming participation in two investor conferences scheduled for March. The company, which specializes in developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet need, will make these presentations available through webcasts.
The company has confirmed that webcast replays will be accessible on the VYNE website for a 90-day period following each event. This initiative demonstrates VYNE's commitment to maintaining transparency with investors and sharing updates about their development pipeline.
VYNE Therapeutics has initiated a Phase 1b trial for VYN202, its oral BD2-selective BET inhibitor, in patients with moderate-to-severe plaque psoriasis. The trial will evaluate once-daily doses over 12 weeks, focusing primarily on safety assessment, with secondary objectives including pharmacokinetic profile and efficacy measurements through PASI scores.
The company expects to report top-line data from this randomized, placebo-controlled trial by year-end 2025. Previous Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trials demonstrated VYN202's favorable safety profile and ability to inhibit multiple inflammatory biomarkers related to Th17, TNF and Th1/myeloid dysregulated activity.
This trial aims to provide insights into VYN202's potential application across various chronic immune-mediated diseases, as psoriasis shares common biological pathways with other inflammatory conditions.
VYNE Therapeutics has completed enrollment in its Phase 2b trial evaluating VYN201 gel (repibresib) for the treatment of nonsegmental vitiligo. The company expects to report top-line data from the 24-week vehicle-controlled treatment period in mid-2025.
The trial represents a significant milestone in the development of VYN201, which VYNE believes has the potential to become a differentiated therapy for vitiligo patients. The United States Adopted Names (USAN) Council has officially adopted "repibresib" as the non-proprietary name for the new chemical entity in VYN201.
VYNE Therapeutics announced positive results from the multiple ascending dose (MAD) portion of its Phase 1a trial for VYN202, a novel BD2-selective BET inhibitor. The study demonstrated a favorable safety and tolerability profile with no serious adverse events or drug-related issues historically associated with earlier BET inhibitors.
Key findings include: favorable pharmacokinetics supporting once-daily dosing, dose-dependent exposure reaching steady state after 7 doses, and robust pharmacodynamic activity. The drug showed no interaction with methotrexate and demonstrated dose-dependent increases in target engagement biomarker HEXIM-11, with maximal effect at 0.5mg to 1.0 mg QD. VYN202 also inhibited multiple inflammatory biomarkers related to Th17 and Th1/myeloid activity.
VYNE Therapeutics reported Q3 2024 financial results and pipeline updates. The Phase 2b trial of VYN201 for vitiligo is expected to complete enrollment in December 2024, with top-line results anticipated mid-2025. The company reported positive Phase 1a SAD data for VYN202, with MAD data expected in Q4 2024. Financial highlights include cash position of $70.2 million, expected to fund operations through end of 2025. Q3 revenues were $0.1 million, with R&D expenses increasing to $10.2 million. Net loss for Q3 2024 was $12.2 million ($0.29 per share).
VYNE Therapeutics has announced positive Phase 1a single ascending dose (SAD) data for VYN202, its novel BD2-selective BET inhibitor. Key findings include:
1. Safety: VYN202 was generally well-tolerated across all dose groups with no drug-related adverse events.
2. Pharmacokinetics: Dose-dependent exposure of VYN202 in blood was observed.
3. Pharmacodynamics: Activity was noted on target engagement and inflammatory biomarkers.
The company has initiated the multiple ascending dose (MAD) portion of the trial, with results expected in Q4 2024. This data will inform planned studies in psoriasis and rheumatoid arthritis.
VYNE Therapeutics Inc. (Nasdaq: VYNE), a clinical-stage biopharmaceutical company, has announced its participation in two significant investor conferences in September 2024. The company, which focuses on developing therapies for chronic inflammatory and immune-mediated conditions, will attend:
1. The H.C. Wainwright 26th Annual Global Investment Conference from September 9-11 in New York, NY, where they will engage in one-on-one investor meetings.
2. The Stifel 2024 Virtual Immunology and Inflammation Summit on September 17-18, featuring a fireside chat presentation on Tuesday, September 17 at 8:30 AM ET, along with one-on-one investor meetings.
A webcast of the Stifel presentation will be available, with a replay accessible on VYNE's website for 90 days post-event.
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