Biofrontera

The FDA has approved an expanded indication for the topical gel Ameluz (10% aminolevulinic acid hydrochloride) for photodynamic therapy of superficial basal cell carcinoma in combination with BF‑RhodoLED lamps. Ameluz is thus the first drug approved by the FDA for photodynamic therapy of a type of skin cancer. In the phase‑3 study, 66% of patients treated with Ameluz‑PDT met the primary endpoint versus 5% with placebo; histological clearance was 76% versus 19%. Biofrontera plans to launch the product for this indication in late Q4 2026 to Q1 2027 through its existing sales organization. » More on de.investing.com

Biofrontera reports a 17% revenue increase in Q1 2026 to $10.1 million and a gross margin of 80% versus 62% a year earlier, driven by higher Ameluz sales and price increases. Operating loss narrowed slightly; net loss was $4.8 million, or $0.41 per share. Management attributes the margin improvement to a strategic transaction and a new earn-out structure and expects 2026 revenue to reach $46.76 million with positive EPS in Q4 2026. » More on de.investing.com

Biofrontera reports record revenue of USD 17.1 million in Q4 2025 (+36% year-on-year) and its first net profit of USD 5.6 million. The cost structure improved markedly following a strategic transaction with Biofrontera AG, reducing COGS by 45% and lifting the gross margin to 82%; adjusted EBITDA was USD 4.9 million (29% margin). The pre-market share price rose 7.07% to USD 0.93. Management expects further revenue growth and full realization of the cost benefits in 2026, as well as upside potential from product developments and possible FDA approvals. » More on de.investing.com