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Biofrontera Inc.Bullish
Biofrontera Inc. has received FDA approval for its supplemental New Drug Application for Ameluz topical gel in combination with the BF-RhodoLED lamp series to treat superficial basal cell carcinoma (sBCC) in adults. Ameluz is now the first and only photodynamic therapy approved in the U.S. for skin cancer treatment, with an official product launch scheduled between late Q4 2026 and Q1 2027.…more
Biofrontera Inc.
Biofrontera Inc. reported its financial results for the second quarter of 2026. As of August 11, 2026, the company had 14,852,359 shares of common stock outstanding, and it held 4,659,000 USD in cash and cash equivalents as of June 30, 2026.…more
Biofrontera Inc.
Biofrontera reported second-quarter 2026 revenue of $12.0 million, a 32.9% increase year-over-year, with a net loss narrowing significantly to $0.6 million ($0.05 per share) from $5.3 million in the prior-year period. The improved financial performance was driven by a restructured cost base and steady demand for Ameluz, as the company continues to target cash flow breakeven in 2026.…more
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Biofrontera Submits sNDA to FDA to Expand Ameluz® PDT Indications
Biofrontera has submitted a supplemental New Drug Application to the FDA to expand the use of its Ameluz® photodynamic therapy to the extremities, neck, and trunk. This move aims to broaden the treatment indication beyond the currently approved face and scalp areas.…more
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Biofrontera's photodynamic therapy, Ameluz, has received FDA approval for the treatment of superficial basal cell carcinoma. This label expansion allows the company to offer a non-surgical treatment option, potentially driving future revenue growth.…more
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The FDA has approved a label update for Biofrontera's Ameluz gel to include specific warnings regarding hypersensitivity. This regulatory update aims to enhance safety information for healthcare providers and patients.…more
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