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VYNE Therapeutics Provides Program Update on Oral BET inhibitor VYN202

1. FDA lifted clinical hold on VYNE's VYN202 for female patients. 2. VYNE extended its cash runway into Q4 2026 following program updates. 3. VYN202 shows significant improvements in psoriasis symptoms in clinical trials. 4. Further updates to follow regarding Phase 2b study of another candidate. 5. VYNE secured design agreement for male toxicity study with the FDA.

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Why Bullish?

The lifting of the clinical hold indicates regulatory progress. Historical examples show that positive FDA news often leads to stock price increases.

How important is it?

The FDA's decision is critical for VYNE's prospects, directly influencing investor sentiment and future trial enrollment.

Why Short Term?

Investors may react quickly to FDA news, impacting stock price soon after. Similar past announcements often result in immediate market response.

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July 02, 2025 07:45 ET  | Source: VYNE Therapeutics Inc. 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.    VYN202 Program UpdateIn April, the FDA placed a clinical hold on the Company’s Phase 1b trial following an observation of testicular toxicity in dogs from a non-clinical toxicology study of VYN202. A No-Observed-Adverse-Effect Level (NOAEL) was established covering all clinical doses in females. The FDA has lifted the clinical hold for female patients on the 0.25 mg and 0.5 mg doses in this Phase 1b psoriasis trial. The 1 mg dose was not included at this time in the revised protocol submitted to the FDA due to its lower toxicological safety margin as compared to the 0.25 mg and 0.5 mg doses. Sufficient data from a 12-week non-clinical toxicology study of VYN202 in dogs would be required in order to resume the trial in male clinical subjects, and the design of this toxicology study has been agreed upon with the FDA. Following the clinical hold, VYNE made the decision to unblind the clinical data from the subjects who were enrolled in the study (VYN202 treated: n=6 across 0.25 mg, 0.5 mg and 1 mg doses; Placebo treated: n=1), the results of which are described below. The Company believes that the totality of the data from this study, together with promising results from multiple preclinical models, support the continued advancement of VYN202 into serious, immune-mediated diseases with limited effective treatment options. Based on this assessment, the Company will no longer enroll patients in the Phase 1b psoriasis study, extending the Company’s expected cash runway into the fourth quarter of 2026. VYNE expects to provide further updates on its plans for the VYN202 program following the release of top-line results from the ongoing Phase 2b study of its lead candidate repibresib gel (formerly VYN201), a pan-BD BET inhibitor, for the treatment of non-segmental vitiligo. Preliminary Data from Phase 1b Trial(n=7 enrolled: VYN202: n=6 across 0.25 mg, 0.5 mg and 1 mg doses; Placebo: n=1) Please visit the Events and Presentations site on the VYNE Therapeutics corporate website for data presentation.    Safety and tolerability results No TESAEs or discontinuations due to a clinical TEAENo treatment interruptions due to a clinical TEAENo grades of thrombocytopenia, neutropenia or lymphocytopenia Exploratory efficacy and serum biomarker results All subjects treated with VYN202 had an improvement in signs and symptoms of disease, including scalp psoriasis Improvement in PASI scores ranged from ~27% reduction after 1 week of treatment to ~90% reduction at week 8. Improvements (reduction) in serum cytokine levels involved in the pathogenesis of plaque psoriasis were observed in subjects treated with VYN202 for greater than 1 week, including IL17A, IL17F, IL19 and IL22 ranging from -17% to -83%. There was no change in these serum cytokines for the subject receiving placebo. Two subjects enrolled co-presented with psoriatic arthritis (n=1 treated with VYN202 0.5mg; n=1 treated with placebo) Subject treated with VYN202 0.5 mg reported a four-point improvement in joint pain NRS scale by week 2 which corresponded with a -48% reduction in serum c-reactive protein level, a biomarker associated with psoriatic arthritis and other rheumatic diseases.Subject treated with placebo had no improvement in joint pain NRS and no change in serum c-reactive protein levels. About RepibresibRepibresib is a pan-bromodomain BET inhibitor designed to be locally administered as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways, while providing low systemic exposure. In addition to demonstrating clinical proof-of-concept in vitiligo, repibresib has produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity in several preclinical models (using several different routes of administration). About VYN202VYN202 is an innovative, oral small molecule BET inhibitor that has potential class-leading selectivity and potency for BD2 vs. BD1. By maximizing BD2 selectivity, VYNE believes VYN202 has the potential to be a differentiated, more conveniently administered, non-biologic treatment option for both acute control and chronic management of immuno-inflammatory indications, in which the damaging effects of unrestricted inflammatory signaling activity are common. About VYNE Therapeutics Inc. VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE’s unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity. For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts. Investor Relations:John FrauncesLifeSci Advisors, LLC917-355-2395jfraunces@lifesciadvisors.com  Tyler ZerondaVYNE Therapeutics Inc.908-458-9106Tyler.Zeronda@VYNEtx.com  Cautionary Statement Regarding Forward-Looking Statements This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical development of VYN202, the potential benefits of VYN202, the timing of reporting results for the Phase 2b study of repibresib, VYNE’s expected cash runway, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to successfully develop its product candidates; the timing of commencement of future preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and VYNE’s other filings from time to time with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events. Third-party products and company names mentioned herein may be the trademarks of their respective owners.

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