BTIG reiterates Buy rating on VYNE Therapeutics stock ahead of vitiligo trial data

Investing.com - BTIG has reiterated its Buy rating and $5.00 price target on VYNE Therapeutics (NASDAQ:VYNE), currently trading at $1.51 with a market cap of $25.2 million. InvestingPro data shows analysts maintain a strong buy consensus with price targets ranging from $4.50 to $10.00, noting the stock has risen approximately 65% since the estimated primary completion of its Phase 2b trial for repibresib in vitiligo on June 23, 2025.

The research firm expects topline 24-week Phase 2b repibresib data, anticipated in July or August 2025, to support the topical BET inhibitor as a preferred first-line targeted treatment for vitiligo. With a current ratio of 4.47 and more cash than debt on its balance sheet, VYNE appears well-positioned to advance its clinical programs. Repibresib is being positioned as a potential competitor to Opzelura, a topical JAK inhibitor from Incyte (NASDAQ:INCY) that is currently the only approved vitiligo therapy.

Previous Phase 1b results for repibresib’s 2% dose showed greater efficacy than Opzelura, with a 39% versus 38% mean F-VASI reduction from baseline at 16 weeks versus 24 weeks, respectively. The Phase 2b trial features a longer treatment course of 24 weeks and a 50% higher maximum dose of 3%, which BTIG believes strengthens the odds of achieving at least parity efficacy compared to Opzelura.

BTIG highlights that repibresib’s clean safety profile could be a key differentiator from Opzelura, which has safety concerns and access issues according to the firm’s key opinion leader checks. Despite these challenges, Opzelura’s run rate in vitiligo is likely exceeding $175 million.

The research firm believes repibresib could command significant market share and potentially grow the overall vitiligo market if confirmed to have parity or better efficacy versus Opzelura, with upside in VYNE shares expected to be unlocked at parity efficacy. InvestingPro subscribers can access 8 additional key insights about VYNE’s financial health, growth prospects, and market performance to make more informed investment decisions.

In other recent news, VYNE Therapeutics announced that the U.S. Food and Drug Administration has partially lifted a clinical hold on its Phase 1b trial of VYN202 for moderate-to-severe plaque psoriasis, allowing testing to resume in female patients at specific dose levels. The clinical hold was initially placed due to testicular toxicity observed in dogs during a non-clinical study. Despite the setback, preliminary results from the trial showed no serious adverse events among participants, and improvements in disease symptoms were noted. VYNE has decided to discontinue enrollment in the trial, which is expected to extend its cash runway into late 2026. Meanwhile, the company’s ongoing Phase 2b trial of repibresib gel for nonsegmental vitiligo remains unaffected, with top-line results anticipated mid-year. Analysts at H.C. Wainwright have adjusted the price target for VYNE stock to $4.50, maintaining a Buy rating, following the FDA’s clinical hold announcement. The firm remains optimistic about VYNE’s prospects, particularly with the distinct nature of the repibresib compound. VYNE’s leadership continues to engage with the FDA to address the clinical hold on VYN202.

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