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Biofrontera wins FDA nod for Ameluz in superficial BCC as Q3 revenue rises 30%

🇺🇸 Biofrontera Inc. (BFRI) · Fri 13 Nov 2026

The US dermatology company also reports a customs ruling on its redesigned RhodoLED XL-C lamp and a new sNDA to widen the actinic keratosis label.

Biofrontera Inc. reported third-quarter 2026 results on 13 November, citing net product revenue of $9.1m, a gross margin of 74.4% and a net loss of $6.4m for the quarter ended 30 September. The company's announcement describes revenue growth of 30%.

The US Food and Drug Administration approved Ameluz photodynamic therapy (PDT) for superficial basal cell carcinoma (sBCC) on 9 September 2026. Biofrontera plans to launch the new indication in late Q4 2026, running into Q1 2027.

On 14 September, US Customs and Border Protection (CBP) ruled that the redesigned RhodoLED XL-C lamp is not covered by the exclusion order issued by the US International Trade Commission (ITC). The summary of the company's report does not give further detail on the ruling or the device changes.

In October, Biofrontera also submitted a supplemental new drug application (sNDA) to expand Ameluz's actinic keratosis label to the extremities, neck and trunk. An sNDA is the route by which a sponsor asks the FDA to approve changes to an already-authorised product, such as a new use or treatment area. No decision date was given in the material available.

What it means for your team

  • Ameluz PDT now has an FDA-approved sBCC indication, with a US launch planned from late Q4 2026 into Q1 2027. Market-access teams tracking dermatology oncology should watch payer coverage as that launch approaches.
  • The CBP ruling that the redesigned XL-C lamp falls outside the ITC exclusion order bears on device availability. Quality and supply-chain teams should confirm how the redesign affects import and labelling status.
  • The October sNDA seeks to extend the actinic keratosis label to extremities, neck and trunk. It is pending, so regulatory teams should not assume approval or a timeline.

Company's press release (SEC filing): Biofrontera Inc. ↗

Article written by VigiEye from the official source (Biofrontera Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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