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VYNE Therapeutics Inc. (Nasdaq: VYNE) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for dermatological and immuno-inflammatory conditions. Headquartered in Bridgewater, New Jersey, the company was founded in 2003 and initially known as Menlo Therapeutics Inc. before rebranding to VYNE Therapeutics Inc. in September 2020.
VYNE's portfolio includes AMZEEQ, a topical minocycline foam approved for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older. Another key product is ZILXI, which has shown efficacy in managing acne vulgaris. Additionally, VYNE is developing FMX103, presently in Phase III clinical trials aimed at treating moderate-to-severe papulopustular rosacea in adults, and FCD105, a topical combination foam in Phase II trials for moderate-to-severe acne vulgaris.
Expanding its focus, VYNE is advancing the development of serlopitant, a once-daily oral NK1 receptor antagonist, as a treatment for pruritus associated with prurigo nodularis. The company is also innovating in the immuno-inflammatory space with its InhiBET™ platform, featuring advanced product candidates like VYN202 and VYN201. VYN202, an oral small molecule BD2-selective BET inhibitor, has demonstrated promising preclinical results for psoriasis and rheumatoid arthritis. VYN201, designed for local administration, is targeting nonsegmental vitiligo and has shown positive Phase 1b clinical trial results.
Recent developments highlight VYNE's commitment to advancing its pipeline, including the initiation of a Phase 2b trial for VYN201 in vitiligo and clearance of the Investigational New Drug (IND) application by the FDA for VYN202, paving the way for its first-in-human studies.
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.
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.
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