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On Monday, H.C. Wainwright adjusted its price target on VYNE Therapeutics (NASDAQ:VYNE) shares, reducing it to $4.50 from the previous $5.75, while sustaining a Buy rating on the stock. According to InvestingPro data, analyst targets for VYNE range from $4.50 to $10.00, with the stock currently trading at $1.43, down over 20% in the past week. The revision follows VYNE’s announcement on April 25 that the U.S. Food and Drug Administration (FDA) has verbally communicated a clinical hold on the company’s Phase 1b study of VYN202, which is being evaluated for moderate-to-severe plaque psoriasis.
The clinical hold was initiated subsequent to the discovery of testicular toxicity in dogs during a non-clinical toxicology study of VYN202. As a result, VYNE has halted all screening, enrollment, and dosing of patients in the Phase 1b trial. The company has expressed its intention to collaborate with the FDA to address the clinical hold promptly. Despite recent challenges, InvestingPro data shows VYNE maintains a strong liquidity position with a current ratio of 4.35 and more cash than debt on its balance sheet.
It is pertinent to note that there have been no serious adverse events reported among the subjects enrolled in the Phase 1b study thus far. Additionally, the clinical hold is specific to the VYN202 program and does not impact VYNE’s other ongoing trials. The company’s Phase 2b trial of repibresib gel for nonsegmental vitiligo is proceeding without any issues. Repibresib, a different compound from VYN202, is a locally applied pan-BD BET inhibitor, contrasting with VYN202’s oral, systemic BD2-selective BET inhibition approach.
H.C. Wainwright remains optimistic about VYNE’s prospects, citing the distinct nature of the repibresib compound and its unrelated mechanism of action, which suggests that the preclinical toxicity findings for VYN202 should not affect the repibresib studies. The firm anticipates further updates on both the VYN202 program, including progress towards resolving the clinical hold, and the expected mid-year top-line results from the repibresib Phase 2b trial’s 24-week double-blind, vehicle-controlled segment. With a market capitalization of just $21.21 million, InvestingPro analysis suggests the stock is currently undervalued, though investors should note that analysts expect sales to decline in the current year.
In other recent news, VYNE Therapeutics announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Phase 1b trial of VYN202, a treatment candidate for moderate-to-severe plaque psoriasis. This decision was made following the discovery of testicular toxicity in dogs during a non-clinical toxicology study. Despite this setback, no serious adverse events have been reported in human subjects enrolled in the trial thus far. VYNE has halted all screening, enrollment, and dosing of patients in the affected study but remains committed to resolving the issue promptly in discussions with the FDA. Meanwhile, the company’s Phase 2b trial of repibresib gel for nonsegmental vitiligo continues unaffected, with top-line results expected by mid-year.
In light of these developments, H.C. Wainwright analyst Joseph Pantginis maintained a Buy rating on VYNE stock but reduced the price target from $5.75 to $4.50, citing potential hurdles such as inconclusive trials and funding challenges. VYNE had recently initiated the Phase 1b trial for VYN202, marking a significant step in its development, with the first subject dosed and plans to enroll up to 80 patients. The trial aims to evaluate the safety of VYN202, with results anticipated by the end of 2025. The company is also exploring the potential initiation of a parallel trial for rheumatoid arthritis or other inflammatory diseases.
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