FDA reviews Biofrontera's sNDA for Ameluz dosage increase

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WOBURN, MA – Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplementary New Drug Application (sNDA) for reviewing an increased dosage of its drug Ameluz®. The FDA has set a target action date of October 4, 2024, to decide on the application which proposes to raise the maximum approved dosage from one to three tubes per treatment for actinic keratosis (AK), a pre-cancerous skin condition.

The sNDA (supplementary New Drug Application) is backed by two Phase 1 safety studies that evaluated the impact of using up to three tubes of Ameluz® in one session. The studies aimed to demonstrate that the increased dosage does not lead to significantly higher systemic exposure or adverse events compared to the current single-tube dosage.

According to Hermann Luebbert, CEO of Biofrontera Inc., the studies showed “robust safety parameters” and the systemic and application site adverse events were equivalent to those observed with one tube.

Actinic keratosis is caused by long-term sun exposure and can potentially progress to squamous cell carcinoma, a type of skin cancer, if left untreated. In the United States, an estimated 58 million people were affected by AK in 2020, with 13 million treatments administered annually.

The safety studies evaluated the blood levels of 5-aminolevulinic acid, the active ingredient in Ameluz®, and its metabolite after treatment. The results indicated that the increase in blood concentrations of these compounds was transient and well below levels associated with side effects.

The application of three tubes was also linked to a manageable inflammatory response and pain during illumination, which was treated with a cooling air stream.

Biofrontera Inc. specializes in the commercialization of products for dermatologic conditions, particularly photodynamic therapy (PDT) and topical antibiotics. The company’s licensed products are primarily used for treating AK and impetigo, a bacterial skin infection.

InvestingPro Insights

As Biofrontera Inc. (NASDAQ:BFRI) anticipates the FDA’s decision on its increased dosage sNDA for Ameluz®, investors may be keen on understanding the financial health and market sentiment surrounding the company. The InvestingPro data reveals a market cap of a modest 2.37M USD, reflecting the small size of the biopharmaceutical player. Despite a notable revenue growth over the last twelve months as of Q1 2023, standing at 21.38%, the company has shown an operating income margin of -65.25%, indicating significant challenges in translating top-line growth into operational profitability.

One of the InvestingPro Tips points out that Biofrontera holds more cash than debt on its balance sheet, which could provide a cushion against operational headwinds. However, another tip suggests the stock is in oversold territory, indicating that the market may have overly punished the stock price. With the company’s stock experiencing a significant price drop over the last year, investors might see potential for a rebound if the FDA’s decision turns favorable and the company manages to improve its operational efficiency.

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