Tag Archive for: hypoparathyroidism

Following an initial rejection in 2023, Ascendis Pharma on Tuesday said it faces another regulatory bump in the road for TransCon PTH with a three-month delay in the ongoing FDA review.

Revenue from AstraZeneca’s rare diseases portfolio, boosted by the $39 billion acquisition of Alexion in 2021, has swelled in recent years, to nearly $7.8 billion in 2023.

Ascendis Pharma A/S said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker’s experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination.

The funds, coupled with earlier Series A financing, provide the Indiana-based company with about $150 million in total funding that will support its clinical asset and other developmental programs, according to CEO Kent Hawryluk.