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BioWorld - Saturday, July 11, 2026
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Home » Zealand gets a second CRL in ultra-rare disease
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Zealand gets a second CRL in ultra-rare disease

Oct. 9, 2024
By Lee Landenberger
The U.S. FDA has issued yet another complete response letter (CRL) for dasiglucagon, a glucagon receptor agonist, being developed by Zealand Pharma A/S for treating congenital hyperinsulinism, an ultra-rare disease that is also being targeted by at least two other companies. This CRL is pegged to the timing of a third-party manufacturing facility reinspection that was done in August and September. The agency also wants some additional clinical analysis from the phase III study.
BioWorld Regulatory Endocrine/metabolic Peptide U.S. FDA

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