Krystal Biotech, Inc. (KRYS) has disclosed a new risk, in the Demand category.
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Krystal Biotech, Inc. faces significant risks related to scaling up its FDA-approved manufacturing process for VYJUVEK to meet rising demand and improve efficiencies. The company has designed and validated a new process intended to increase production output, but it must secure FDA approval for these changes through a Prior Approval Supplement (PAS) before implementation. This process carries inherent risks such as cost overruns, design flaws, and issues with consistency and stability, which could delay or prevent FDA approval. Any delay in obtaining approval may impede VYJUVEK’s market availability and negatively impact Krystal Biotech’s business operations and financial health.
The average KRYS stock price target is $211.14, implying 23.58% upside potential.
To learn more about Krystal Biotech, Inc.’s risk factors, click here.
