Biofrontera (BFRI) shares closed more than 16% higher, easing from a 27% advance soon after the company said on Tuesday that a propylene glycol-free version of its Ameluz nonoemulsion gel was added by the US Food and Drug Administration's Orange Book.
Inclusion of Ameluz in the agency's Approved Drug Products with Therapeutic Equivalence Evaluations publication, more commonly known as the Orange Book, significantly broadens the drug's potential reach with doctors and other prescribers who use it to find detailed information about approved medications, their composition and exclusivity details.
Ameluz is used together with the company's RhodoLED lamps to treat pre-cancerous skin lesions, with the patent for the revised formulation of Ameluz issued on April 22, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024, the company said.
Price: 0.65, Change: +0.08, Percent Change: +14.01
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