--- title: "Biofrontera gets FDA approval for Ameluz in superficial basal cell carcinoma" url: "https://aibio.space/news/biofrontera-gets-fda-approval-ameluz-superficial-basal-cell-carcinoma/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-09-14" section: "Company Updates" tickers: "NASDAQ:BFRI" source: "https://www.sec.gov/Archives/edgar/data/1858685/000149315226042508/ex99-1.htm" summary: "The company says Ameluz with the RhodoLED lamp is the first and only photodynamic therapy approved in the United States to treat a skin cancer. It plans a" --- By the aibio.space news desk. Sources - [Biofrontera Inc. Form 8-K](https://www.sec.gov/Archives/edgar/data/1858685/000149315226042508/ex99-1.htm) - [Biofrontera Inc. 10-K (2026-03-19): business](https://www.sec.gov/Archives/edgar/data/1858685/000149315226011625/form10-k.htm) - [Biofrontera Inc. financial data (SEC XBRL)](https://www.sec.gov/Archives/edgar/data/1858685/000149315226011625/) [BFRI](https://aibio.space/companies/biofrontera-bfri/) 2026-09-14 # Biofrontera gets FDA approval for Ameluz in superficial basal cell carcinoma Tickers [BFRI](https://aibio.space/companies/biofrontera-bfri/) The company says Ameluz with the RhodoLED lamp is the first and only photodynamic therapy approved in the United States to treat a skin cancer. It plans a launch from late fourth quarter 2026 through first quarter 2027. ## Key facts - **Company**: Biofrontera Inc. (NASDAQ: BFRI) - **News type**: Company Updates - **Primary source**: [Biofrontera Inc. Form 8-K](https://www.sec.gov/Archives/edgar/data/1858685/000149315226042508/ex99-1.htm) *A gloved hand holding a blood collection tube. CC0, via rawpixel. The picture shows the field, not the companies named.* Biofrontera Inc. (NASDAQ: [BFRI](https://aibio.space/companies/biofrontera-bfri/)) said on September 14, 2026 that the U.S. Food and Drug Administration has approved its supplemental New Drug Application for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with photodynamic therapy (PDT) and the BF-RhodoLED lamp series, for the treatment of superficial basal cell carcinoma (sBCC) in adults. The company furnished the press release in a Form 8-K dated the same day. The company says Ameluz is now the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical PDT in the United States indicated to treat both a pre-cancerous skin condition, actinic keratosis (AK), and a skin cancer. Hermann Luebbert, the company's Chief Executive Officer and Chairman, said: "FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera." ## The trial behind the approval The approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed sBCC. The primary endpoint was a composite of clinical and histological complete response of a main target lesion 12 weeks after the start of the last PDT cycle. The company says that target was reached in 66% of subjects treated with Ameluz PDT (95 of 145), compared with 5% of subjects treated with placebo-PDT (2 of 42). Histological clearance of the main target lesion was seen in 76% of Ameluz PDT patients, compared with 19% with placebo-PDT. Of Ameluz-treated subjects, 83% achieved complete clinical clearance of all target lesions, compared with 21% for placebo-PDT. The most common adverse reactions were application-site reactions, which the company describes as consistent with the known safety profile of Ameluz PDT. The release gives no p-values, no rates for those reactions, and no follow-up beyond 12 weeks after the last treatment cycle, so it does not show how long the clearances last. The efficacy figures are the company's own summary of the trial. ## Market, launch and the company Basal cell carcinoma is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, according to the Skin Cancer Foundation. Published estimates suggest the superficial subtype accounts for approximately 15%-20% of BCC cases, or an estimated 540,000 to 720,000 sBCC cases annually in the U.S. The company says the new indication uses the same topical product and the same red-light device as its AK indication, so existing customers can adopt it quickly. The company plans an official launch of the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027, using its existing commercial organization and installed lamp base. Luebbert said the approval gives new dermatology practices a reason to purchase a RhodoLED lamp and begin using Ameluz PDT. Biofrontera Inc. formed in 2015 as a subsidiary of Biofrontera AG and completed its initial public offering in 2021. On October 20, 2025, it acquired all rights in the United States to Ameluz and RhodoLED under an asset purchase agreement and an earnout agreement with the Biofrontera Group. Its annual report filed March 19, 2026 reports revenue of $41.7 million for 2025, compared with $37.3 million for 2024. Research and development expense was $3.7 million for 2025 and $2.1 million for 2024. The net loss was $10.5 million for 2025 and $17.8 million for 2024. Cash from operations was negative $13.4 million for 2025 and negative $10.3 million for 2024. Cash and cash equivalents were $6.4 million at December 31, 2025, and $4.7 million at June 30, 2026, according to the company's quarterly report. The release does not give a revenue or cash figure for the approval itself. The new indication earns nothing until launch, which is months away, and cash of $4.7 million at June 30, 2026 compares with $13.4 million used in operations in 2025. The company's own risk list includes patent infringement claims against it and its ability to market, commercialize and sell its products. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story BFRI Biofrontera Inc. 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Cite as: aibio.space, "Biofrontera gets FDA approval for Ameluz in superficial basal cell carcinoma", 2026-09-14, https://aibio.space/news/biofrontera-gets-fda-approval-ameluz-superficial-basal-cell-carcinoma/