Biofrontera shares surge 14.68% premarket after filing sNDA for Ameluz-PDT in sBCC treatment.

Biofrontera Inc. (Nasdaq: BFRI) surged 14.68% in premarket trading following the announcement of a supplemental New Drug Application (sNDA) for Ameluz®-PDT to treat superficial Basal Cell Carcinoma (sBCC). The submission to the FDA, based on a Phase 3 trial, demonstrated highly statistically significant results (p<0.0001), with 65.5% complete clearance of target lesions in the Ameluz® arm versus 4.8% in the placebo group. The filing also highlights favorable one-year recurrence rates and strong patient-reported outcomes, supporting potential label expansion for cutaneous oncology indications. The news underscores Biofrontera’s progress in broadening Ameluz®’s therapeutic applications, positioning it to address a large market with over 3 million annual sBCC cases in the U.S.