07:34 AM EDT, 08/12/2024 (MT Newswires) -- Ascendis Pharma ( ASND ) said Monday the US Food and Drug Administration has approved Yorvipath, the company's treatment for hypoparathyroidism, a rare endocrine disease, in adults.

The approval is based on data from the global phase 2 and 3 trials.

The company said it is finalizing the manufacturing of a commercial product for the US market and expects the availability of an initial supply in Q1 2025. It also said it is planning to seek FDA approval for existing manufactured products and aim for a US launch this Q4.

At launch, Ascendis will provide patient support and financial assistance through its Ascendis Signature Access Program.

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