Biofrontera Gains FDA Approval for Ameluz to Treat Superficial Basal Cell Carcinoma

Key Facts

In a move reflecting the ongoing expansion of innovative dermatological treatments, Biofrontera announced it has received FDA approval for Ameluz in combination with the RhodoLED lamp for the treatment of superficial basal cell carcinoma (sBCC). According to reports, this marks the first and only photodynamic therapy approved in the United States to treat this specific type of skin cancer. The approval follows clinical evaluations demonstrating the efficacy of the platform, providing a critical new option for patients with multiple lesions or those in cosmetically sensitive locations.

This regulatory milestone is significant for Biofrontera as it addresses a market with an estimated 540,000 to 720,000 sBCC cases annually in the U.S. Clinical data showed that 83% of Ameluz-treated subjects achieved complete clinical clearance of all target lesions, compared to just 21% in the placebo group. These robust results, per market data and clinical reports, underscore the potential for Ameluz to become a primary growth driver for the company’s clinical portfolio.

Regarding market performance, BFRI shares stood at $1.55 at the close of September 11, 2026, having reached a day high of $1.62. With no major upcoming healthcare-specific catalysts in the immediate economic calendar, investors will focus on how this market expansion translates into future revenue growth. Traders may watch the $1.50 level, the day low from September 11, as a potential immediate support zone.