Cosmo shares surge over 20% after Breezula Phase III trials hit key goals

Investing.com -- Cosmo Pharmaceuticals’ shares jumped more than 20% on Wednesday after the Swiss drugmaker reported that two Phase III trials of its hair-loss treatment Breezula met their co-primary endpoint, showing large relative improvements in hair count and a favorable safety profile.

The company released topline six-month data from its SCALP Phase III program in men with androgenetic alopecia. 

The report said both studies showed statistically significant gains on target area hair count, recording over 539% and above 168% relative improvements over vehicle. 

A pooled analysis showed a over 252% increase with p<0.05. Patient-reported outcomes were described as aligned with the clinical findings, which the analysts at Kepler Cheuvreux said supported “the robustness of the signal at six months.”

Cosmo, which develops therapies in dermatology, gastrointestinal diseases and health-technology applications, reported a safety profile that the report described as favorable. 

Treatment-emergent adverse events were 5.1% in the clascoterone arms compared with 6.1% in the placebo group. 

The brokerage said the results were consistent with the drug’s local, non-systemic activity and noted that “no systemic androgen-related events were reported,” a detail highlighted as maintaining a differentiation from oral finasteride .

The trials, which enrolled 1,465 participants across two studies, represent the first full topline dataset publicly disclosed from the six-month analysis. 

Cosmo said it “remains on track to complete the 12-month safety follow-up in spring 2026, after which parallel FDA/EMA filings are planned.”

Absolute hair-count values were not released, and the note stated that cross-trial comparisons were difficult to establish at this stage, citing the limits of early datasets.

Kepler referenced the magnitude of separation from vehicle, stating it was “notably higher than what has historically been observed with topical minoxidil/finasteride over similar timeframes,” while emphasizing that the observation was restricted to the disclosed relative data. 

The brokerage also described the safety findings as central, stating that “tolerability (was) comparable to vehicle and no evidence of systemic exposure” was identified. 

It said this characteristic positioned Breezula within a category that has not seen a topical androgen-receptor inhibitor advance this far in development in more than three decades.

Cosmo has identified Breezula as one of its key programs, and the note said the update “offers a clear step forward for the equity story,” with the 12-month readout labeled the final major element before regulatory submission. 

The company’s broader business includes commercialized dermatology and gastrointestinal products, and the brokerage described Breezula as a mid-term growth driver within its pipeline.

The Phase III results were presented as materially reducing risk for the program ahead of the upcoming safety dataset. “We now look forward to the 12-month dataset expected in spring 2026,” the brokerage said, outlining the next expected milestone for the clascoterone development path.