Shares in a Pittsburgh-based biotech company fell sharply on Monday after the firm reported that a key decision date from the Food and Drug Administration for the company's experimental rare skin condition treatment drug had been delayed by three months.
Krystal Biotech Inc. (NASDAQ: KRYS) saw its stock decline by about 8.5% as of 1 p.m. on Monday following its discloser that the FDA delayed the Prescription Drug User Fee Act (PFDUA) date for a topical, redosable gene therapy called B-VEC, Krystal's candidate to treat dystrophic epidermolysis bullosa candidate, which is sometimes referred to as "butterfly child" due to the fragile-like conditions that become of the skin as a result of the disease.
The new PDUFA date has been pushed to May 19, and proposed labeling discussions are to occur "no later than" April 20, the company said in a release. It also noted that the FDA notified the company of this delay due to manufacturing information that Krystal had submitted as part of the regulatory process.
According to Krystal, this additional information included details about a replaced hardware unit in the "concentration step of the manufacturing process" of the drug and relevant comparability data supporting the use of this unit. Krystal claimed these changes did not affect processing parameters or product contact materials but that the FDA "considered this new information as a major amendment to the application that will require additional time for review."
"While we are disappointed that this change was viewed as a major amendment, we are committed to working with the FDA as it completes its review of the B-VEC application," Krish S. Krishnan, chairman & CEO at Krystal Biotech, said in a press release. "We will continue our commercial readiness efforts and upon approval bring this important treatment to DEB patients as soon as possible."
