Ascendis Pharma files NDA for hypoparathyroidism candidate TransCon PTH

Danish biotech firm Ascendis Pharma (Nasdaq: ASND) saw its shares gain 2.6% to $ 2.22 late-morning, as it moved a step closer to bringing second commercial product to market.

Ascendis today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism. TransCon PTH has been granted Orphan designation in the USA and European Union.

“We believe the best way to treat hypoparathyroidism is to replace the missing endogenous hormone at stable, physiological levels 24 hours a day. Accordingly, our data support that TransCon PTH, if approved, could become the first-in-class therapy to address the underlying cause of disease and address the urgent needs of patients in the US, who today have no such treatment options available,” said Dana Pizzuti, Ascendis Pharma’s senior vice president and chief medical officer.