Biofrontera Seeks FDA Nod to Expand Ameluz Use to Full-Body Actinic Keratoses
BFRI sits 75% above its 52-week low of $0.555.
Summary
Biofrontera has submitted a supplemental New Drug Application to the FDA seeking approval to expand Ameluz red light photodynamic therapy to treat actinic keratoses on the full body. Currently Ameluz is approved for actinic keratoses on the face and scalp, so this would broaden the addressable patient population. The company received FDA approval in September for Ameluz to treat superficial basal cell carcinoma, and this new filing extends the franchise further. Given the company's small market cap and going concern warning, any regulatory expansion is material to its commercial outlook. The FDA's decision timeline has not been disclosed.
At the time of this announcement, BFRI was trading at $0.97 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $13.9M. The 52-week trading range was $0.55 to $1.66. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Reuters.