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VYNE Therapeutics Inc. develops differentiated therapies for chronic inflammatory and immune-mediated conditions through proprietary BET inhibitor programs. News about VYNE centers on its InhiBET™ platform, Repibresib gel for nonsegmental vitiligo, and VYN202, an oral BD2-selective BET inhibitor being evaluated for immune-mediated diseases.
Company updates also cover clinical and regulatory communications, nonclinical toxicology work, quarterly operating results, cost-control actions, capital-structure matters, governance developments, and shareholder voting matters tied to its Nasdaq-listed common stock.
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.
VYNE Therapeutics Inc. (Nasdaq: VYNE) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Initiation of a Phase 2b trial for VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025.
2. Ongoing Phase 1a SAD/MAD trial for VYN202, with data expected in Q3 and Q4 2024.
3. Cash position of $78.1 million as of June 30, 2024, expected to fund operations through the end of 2025.
4. Q2 2024 financial results: Revenue of $0.2 million, R&D expenses of $7.3 million, G&A expenses of $3.3 million, and a net loss of $9.4 million ($0.22 per share).
5. Appointment of Dr. Subhashis Banerjee as Senior VP of Clinical Development.
VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced the granting of a composition of matter patent for VYN202, its novel BD2-selective BET inhibitor. The patent, GB Patent No. 2621505, was granted by the United Kingdom's Intellectual Property Office and covers the compound in VYNE's VYN202 program. The patent has a 20-year term expiring in June 2042.
David Domzalski, President and CEO of VYNE, emphasized the importance of this patent for the development of VYN202, which the company believes is the most potent and BD2-selective BET inhibitor in development. The patent is derived from Tay Therapeutics 's PCT application and is exclusively licensed to VYNE. This marks the first of the nationally filed applications to be granted, with VYNE seeking protection in additional jurisdictions as they progress their BET inhibitor pipeline.
VYNE Therapeutics has appointed Dr. Subhashis Banerjee as Senior Vice President of Clinical Development, effective July 8, 2024. Dr. Banerjee brings over 25 years of drug development experience, having worked on notable immunological therapies at Bristol Myers Squibb, Eli Lilly, Pfizer, and AbbVie. His expertise will be instrumental in advancing VYNE's strategy of developing BET inhibition treatments for immuno-inflammatory conditions. The company also announced the issuance of stock options to Dr. Banerjee and other employees as part of their 2024 Inducement Award Plan, with options priced at $1.96 per share.
VYNE Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the Leerink Partners Therapeutics Forum scheduled for July 9, 2024. The event will focus on Immunology & Inflammation (I&I) and Metabolic Diseases. VYNE will engage in one-on-one meetings to discuss their proprietary and innovative therapies for immuno-inflammatory conditions. The company aims to showcase its developments and strengthen its position within the biopharmaceutical field. This participation highlights VYNE's commitment to advancing treatments for critical health issues.