Biofrontera Inc. announced that the U.S. Food and Drug Administration accepted its supplemental New Drug Application for Ameluz® photodynamic therapy in the treatment of superficial basal cell carcinoma (sBCC) on February 11 2026. The acceptance removes the final regulatory hurdle before the company can seek approval for this new indication and positions Ameluz as the first and only PDT photosensitizer approved for sBCC in the United States.
Ameluz® is a topical gel containing aminolevulinic acid hydrochloride that, when paired with the RhodoLED® red‑light lamp, generates reactive oxygen species to destroy targeted cells. Biofrontera acquired full U.S. rights to Ameluz and RhodoLED on October 23 2025, and the transaction introduced a royalty‑based cost structure that reduces the payment rate to 12‑15 % of U.S. net sales from the previous 25‑35 %. The lower royalty rate is expected to lift gross margins as the product scales beyond its current actinic keratosis niche.
Superficial basal cell carcinoma accounts for 10‑25 % of the approximately 3.6 million new BCC cases reported annually in the United States. If approved, Ameluz could capture a share of this sizable market, potentially adding hundreds of millions of dollars in addressable sales. The FDA’s PDUFA target action date of September 28 2026 gives Biofrontera a clear timeline to launch the expanded indication within 9–10 months.
The Phase 3 study that underpins the sNDA met its primary endpoint of complete clearance at 12 weeks, achieving a 94 % clearance rate in the treatment group versus 0 % in the control group. The study also reported a 98 % recurrence‑free rate at 12 months, underscoring the durability of the response and supporting the safety profile of Ameluz in this patient population.
Current sBCC treatments rely on surgical excision, Mohs micrographic surgery, or destructive modalities such as cryotherapy and radiation. Ameluz offers a non‑invasive alternative that can be administered in an outpatient setting, potentially reducing procedural costs and improving patient convenience. No other PDT products have received FDA approval for sBCC, giving Biofrontera a first‑mover advantage in a largely untapped segment.
CEO Dr. Hermann Luebbert said the FDA’s acceptance “confirms the strength of our clinical data and the robustness of our manufacturing platform.” He added that the new royalty structure “will accelerate margin expansion and support the company’s path to profitability.”
The sNDA acceptance is a pivotal step that could transform Biofrontera’s revenue mix, broaden its market reach, and reinforce its competitive position in dermatology photodynamic therapy. With the PDUFA target in place, the company is poised to bring a first‑in‑class treatment to patients and investors alike within the next year.
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