FDA slaps CRL on TransCon PTH in hypoparathyroidism NDA

Shares of Danish biotech Ascendis Pharma (Nasdaq: ASND) leapt, despite the company revealing that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the TransCon PTH (palopegteriparatide) New Drug Application (NDA) for the treatment of adults with hypoparathyroidism.

In the letter, the FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product.

On a positive point, the FDA did not express concern about the clinical data submitted as part of the NDA package and no new pre-clinical studies, or Phase III clinical trials to evaluate safety or efficacy, were requested in the letter.