Biofrontera Inc. (BFRI) stock plummeted 8.85% in the pre-market trading session at the price of $4.52 following FDA approval of cGMP laboratory in Leverkusen.
BFRI is a biopharmaceutical firm that develops and commercializes pharmaceutical products to treat dermatological conditions. The company’s approved products control and treat actinic keratoses, impetigo, and other skin conditions.
Laboratory Approval for Ameluz
On 13th April 2022, BFRI announced the approval of Biofrontera Pharma’s cGMP laboratory in Leverkusen by the U.S. FDA. The contract laboratory had developed for stability testing and batch controlling of Ameluz. The FDA allowed the cGMP laboratory to employ a process of impurity testing, which is an essential feature of the gel’s solidity assurance.
This recognition by FDA brings substantial advancements in product efficiency, supply reliability, and quality control. The license allows the execution of necessary testing of product batches in the Leverkusen plant. Resultantly, this new facility will lower reliance on other suppliers and the hazard of product delays and production downtime.
BFRI Market Outlook
The management claims that 2021 was a prosperous year for Biofrontera as the company completed its IPO in October, which laid the groundwork for extending Ameluz pipeline. BFRI stock initiated 2022 with high commercial momentum, working capital, and a strategic plan to create more shareholder value. Moreover, the current license and supply deal with Biofrontera AG has granted BFRI exclusive rights to commercialize Ameluz and RhodoLED XL across the United States.
BFRI stock expects to continue the momentum established in 2021. It will drive revenue growth from client’s budget and boost the opportunity to earn shares from cryotherapy. The company has focused on optimizing the scale and supply of quality products given the raising demand. BFRI’s goal is to enhance the market position of Ameluz as a leading PDT drug to treat actinic keratosis in the United States.