Biofrontera shares surge 19.05% after-hours after filing sNDA for Ameluz-PDT in sBCC with robust Phase 3 trial results.

Biofrontera Inc. surged 19.05% in after-hours trading following the announcement that it submitted a supplemental new drug application (sNDA) to the FDA for Ameluz®-PDT to treat superficial basal cell carcinoma (sBCC). The sNDA includes robust Phase 3 trial data demonstrating 65.5% complete clearance of target lesions in the Ameluz®-PDT arm versus 4.8% in the placebo group, with statistically significant results (p<0.0001). The filing also incorporates favorable one-year follow-up data showing low recurrence rates and strong aesthetic outcomes, supporting the therapy’s potential to expand into cutaneous oncology. This milestone aligns with the company’s strategy to establish leadership in photodynamic therapy (PDT) and could significantly broaden Ameluz®’s market application, driving investor optimism.