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

Biofrontera has completed the pharmacokinetic phase‑1 study of Ameluz in actinic keratoses on the neck, trunk and extremities; 17 patients received treatment and blood samples were analyzed over 10 hours. The data will feed into the planned supplemental new drug application (sNDA) to the FDA, which the company expects in summer 2026, to expand the indication beyond the face and scalp. In parallel, the approval plan includes results from a recently completed phase‑3 study; financially, Biofrontera reported declining revenue and a higher net loss, while Benchmark maintained its buy recommendation with a target price of USD 3.00. » More on de.investing.com

Biofrontera has submitted a supplemental new drug application (sNDA) to the FDA for Ameluz‑PDT to treat superficial basal cell carcinoma. The submission is based on a phase‑3 study of 187 patients that showed a cure rate of 65.5% versus 4.8% in the placebo group and complete histological clearance in 75.9% versus 19%; one‑year follow‑up also documented low recurrence rates. The goal is to expand approval into cutaneous oncology and to use the treatment with the BF‑RhodoLED and RhodoLED XL red‑light lamps. Despite annual sales of $37.16 million and a high gross margin, Biofrontera is not yet profitable; the company recently reported declining revenue and higher net losses, although analysts continue to maintain buy recommendations. » More on de.investing.com