Biofrontera shares surge 20.83% premarket after filing sNDA for Ameluz-PDT in sBCC with robust Phase 3 trial results.

Biofrontera Inc. surged 20.83% in premarket trading following the announcement of filing a Supplemental New Drug Application (sNDA) with the FDA for Ameluz®-PDT to treat superficial Basal Cell Carcinoma (sBCC). The sNDA includes robust Phase 3 trial data showing 65.5% complete clearance of target lesions in the Ameluz®-PDT group versus 4.8% in placebo, with key secondary endpoints also met at high statistical significance (p <0.0001). The submission, which incorporates one-year follow-up data demonstrating durable efficacy and favorable cosmetic outcomes, seeks to expand Ameluz®’s label to include sBCC treatment using the company’s BF-RhodoLED® or RhodoLED® XL devices. This milestone could significantly broaden the product’s market application, aligning with the stock’s sharp premarket gain.