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WOBURN, Mass. - Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company with a market capitalization of $5.4 million and revenue growth of 14.28% in the last twelve months, has recently announced that its patent for a propylene glycol-free formulation of Ameluz®, a photodynamic therapy (PDT) gel, has been listed in the U.S. Food and Drug Administration’s (FDA) Orange Book. This inclusion signifies FDA acknowledgment of the formulation’s safety, efficacy, quality, and intellectual property protection. According to InvestingPro analysis, the company maintains a healthy gross profit margin of 53.26%, though it faces near-term profitability challenges.
The revised formulation of Ameluz®, which is free from propylene glycol—an allergen for some patients—aims to improve patient experience by reducing potential allergic reactions without compromising treatment effectiveness. The patent for this formulation was issued on April 22, 2025, and extends its protection until December 8, 2043. The product itself has been FDA-approved and in use since 2024. InvestingPro data reveals that while the company’s stock has faced recent challenges, analysts maintain optimistic price targets, with comprehensive analysis available in the Pro Research Report, part of InvestingPro’s coverage of over 1,400 US stocks.
Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed pride in the Orange Book inclusion, highlighting the company’s commitment to innovation and patient-centric development. The listing in the Orange Book also serves to prevent generic competition for Ameluz® while the patent remains valid.
Biofrontera specializes in the treatment of dermatological conditions and commercializes Ameluz® in combination with the RhodoLED® lamp series for the treatment of actinic keratosis (AK), pre-cancerous skin lesions that may progress to invasive skin cancers. The company also conducts clinical trials to extend the use of its products for treating non-melanoma skin cancers and moderate to severe acne.
This development is based on a press release statement from Biofrontera Inc. and does not include any forward-looking statements or promotional content. The information provided is strictly factual, based on the company’s recent announcement regarding its patent listing in the FDA’s Orange Book.
In other recent news, Biofrontera reported its first-quarter 2025 earnings, revealing a 9% increase in revenue to $8.6 million. Despite this growth, the earnings fell short of expectations set by Benchmark, which had projected $10.6 million. The company’s net loss improved significantly to $4.2 million, compared to a loss of $10.4 million in the previous year. Benchmark analyst Bruce Jackson responded by lowering the price target for Biofrontera shares to $2.75 from $7.00, although he maintained a Buy rating on the stock. Biofrontera’s management remains optimistic about future growth, citing a new patent for Ameluz that extends protection until 2043 and plans to expand its treatment indications. The company is also preparing to file a supplemental New Drug Application for the treatment of superficial Basal Cell Carcinoma, with approval expected by mid-2026. Biofrontera aims to achieve breakeven through cost control and revenue growth, focusing on expanding the use of Ameluz. These developments are part of Biofrontera’s strategy to strengthen its position in the dermatology market.
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