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Ascendis Pharma Says US FDA Extends Review Period on Hypoparathyroidism Treatment; Shares Drop
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Ascendis Pharma Says US FDA Extends Review Period on Hypoparathyroidism Treatment; Shares Drop
May 14, 2024 12:43 PM

03:20 PM EDT, 05/14/2024 (MT Newswires) -- Ascendis Pharma ( ASND ) said Tuesday the US Food and Drug Administration postponed its decision on the company's new drug application for TransCon PTH, or palopegteriparatide, for adults with hypoparathyroidism,

The regulator plans to make a decision by Aug. 14, three months later than the previous target date, after the company submitted additional information for the review that constituted a major amendment to the application, according to a statement.

Ascendis Pharma ( ASND ) shares fell 6.7% in recent Tuesday trading.

Price: 123.19, Change: -8.83, Percent Change: -6.69

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