Vyne Hit With Downgrades After Repibresib Misses Endpoints In Vitiligo Trial; Traders Still Eye Rebound

BTIG and H.C. Wainwright downgraded Vyne Therapeutics following topline results from the company’s Phase 2b trial of repibresib gel in nonsegmental vitiligo, which failed to meet both primary and secondary endpoints.

BTIG analyst Julien Harrison downgraded the stock to ‘Neutral’ from ‘Buy’ and said the company will analyze the full dataset to guide next steps. He also noted that Vyne intends to seek a development and commercialization partner for repibresib. 

Harrison added that an update is expected in the coming weeks on both repibresib and VYN202, which is currently under partial clinical hold by the U.S. Food and Drug Administration.

H.C. Wainwright analyst Joseph Pantginis also downgraded the stock to ‘Neutral’ from ‘Buy’ and removed the firm’s $4.5 price target, calling the trial outcome “a surprise” that “puts the company in a precarious position.” 

He said the firm will remain on the sidelines pending further clarity on repibresib, additional VYN202 data, or potential new asset acquisitions.

Vyne said that the Phase 2b trial was a randomized, double-blind, vehicle-controlled study conducted at 45 sites across North America, enrolling 177 participants. The trial evaluated the once-daily topical administration of repibresib gel at 1%, 2%, and 3% concentrations compared to vehicle. 

The primary endpoint, defined as the proportion of patients achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24, was not met. The trial also missed a key secondary endpoint (F-VASI75).

However, the company stated that the highest dose group showed a nominally statistically significant treatment effect in percent change from baseline (CFB) in both F-VASI and T-VASI scores at week 24. 

Vyne stated that the outcome was likely affected by a high vehicle effect and a higher-than-expected dropout rate in the active arms. As a result, the company has discontinued treatment in the extension phase and will terminate the trial.

The company reported approximately $39.6 million in cash, cash equivalents, and investments as of June 30. 

Treatment-emergent adverse events (TEAEs) were more frequent in the repibresib arms, with application site pain being the most common. Eight subjects in the treatment group discontinued due to AEs, compared to none in the vehicle group. Most TEAEs were mild and resolved during the study.

CEO David Domzalski said the company was disappointed by the outcome but remains confident in the potential of its InhiBET BET inhibitor platform.

On Stocktwits, retail sentiment for Vyne was ‘extremely bullish’ late Wednesday amid an 11,800% surge in 24-hour message volume.

One user said they went long on Vyne at $0.4189, calling the selloff part of the biotech cycle. “Every setback is a setup for a comeback,” they wrote, adding that while the vitiligo trial missed, the underlying science still showed promise. 

They also pointed to the FDA's recent move regarding the company’s psoriasis program and noted that Vyne has sufficient cash to operate into late 2026.

Another user highlighted Vyne’s $39 million cash position, suggesting the stock could attract activist investors like Tang Capital Management. “If they step in, we could see a bounce,” the user wrote.

Vyne’s stock has declined 88.1% so far in 2025.

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