Krystal Biotech’s Battle to Scale VYJUVEK Production Amid Regulatory Hurdles and Soaring Demand

Krystal Biotech, Inc. (KRYS) has disclosed a new risk, in the Demand category.

Krystal Biotech, Inc. faces significant challenges as it contemplates scaling up the production of VYJUVEK to meet soaring demand and improve cost efficiencies. The company must navigate the complex process of submitting and obtaining approval for a Prior Approval Supplement from the FDA, a task fraught with regulatory, financial, and operational risks. Potential hurdles include process scale-up design issues, stability problems, and batch consistency, which could delay or even prevent FDA approval. Until the new process is approved, Krystal Biotech must rely on its current FDA-approved manufacturing capabilities, which may impede the company’s ability to promptly satisfy market demand for VYJUVEK, potentially harming their business and financial outlook.

Overall, Wall Street has a Strong Buy consensus rating on KRYS stock based on 7 Buys.

To learn more about Krystal Biotech, Inc.’s risk factors, click here.