Zealand Pharma Faces FDA Setback on Dasiglucagon Approval

Zealand Pharma A/S received a Complete Response Letter from the FDA concerning its NDA for dasiglucagon, used for treating congenital hyperinsulinism in pediatric patients, due to inspection timing issues at a third-party manufacturing facility. The company plans to address this by submitting additional analyses by the end of 2024.

Date: 09-10-2024

AI Rating: 5

Zealand Pharma A/S (ZEAL) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Part 1 of its New Drug Application (NDA) for dasiglucagon. This medication is intended for the prevention and treatment of hypoglycemia in pediatric patients suffering from congenital hyperinsulinism. The issuance of the CRL signifies a challenge for the company's drug approval process.

The CRL was not due to concerns about the drug's clinical data or its safety; rather, it was related to the timing of a reinspection at a third-party contract manufacturing facility. While prior inspections noted deficiencies unrelated to dasiglucagon, they have since been resolved, yet the manufacturer has not received its inspection classification post-reinspection. This delay might cause uncertainty in the market regarding the future availability of dasiglucagon and its potential revenue generation.

The company is required to provide additional analyses based on existing continuous glucose monitoring (CGM) data from the Phase 3 clinical program, with an expected submission by the end of 2024. This means that the approval process may be extended, which could influence investor sentiment negatively and affect stock prices.

Overall, the delay in regulatory approval without any concerns about safety or clinical data gives a slightly mixed outlook for investors. The resolution of manufacturing deficiencies is a positive sign, yet the CRL could still cause concern among stakeholders and lead to stock price volatility.

Stocks: ZEAL