Biofrontera shares surge 22.22% after-hours after submitting sNDA for Ameluz-PDT in sBCC treatment with strong Phase 3 data.

Biofrontera Inc. (NASDAQ: BFRI) surged 22.22% in after-hours trading following the announcement of a supplemental new drug application (sNDA) for Ameluz®-PDT to treat superficial basal cell carcinoma (sBCC). The sNDA, submitted to the FDA on November 28, 2025, includes robust Phase 3 data demonstrating 65.5% primary endpoint clearance in the Ameluz®-PDT arm versus 4.8% in placebo (p<0.0001), with favorable one-year recurrence outcomes and high patient satisfaction. The filing seeks label expansion for sBCC treatment using BF-RhodoLED® or RhodoLED® XL lamps, positioning Ameluz® as a potential market-leading photodynamic therapy option. The CEO highlighted the milestone as a strategic step to broaden the drug’s oncology indications. This regulatory progress, coupled with statistically significant clinical results, likely drove the sharp post-market rally, overshadowing conflicting Q3 financial results.