Amneal Pharma Faces Parkinson's Candidate Setback with FDA's CRL
- July 03rd, 2023
- 416 views
Shares of Amneal Pharmaceuticals, Inc. (NYSE: AMRX) dropped over 10% in after-hours trading due to a Complete Response Letter from the FDA regarding the company's New Drug Application for IPX203 to treat Parkinson's disease, a neurological condition characterized by involuntary and uncontrolled movements, including tremors, rigidity, and challenges with balance and coordination.
According to Amneal, the FDA requested additional information on the ingredient carbidopa, and no issues were identified in the letter regarding the efficacy or manufacturing of IPX203.
The company stated that it will work with the FDA to address the comments and move forward, and the financial guidance for 2023 remains unaffected by this development.
$AMRX was trading at $2.65 (-13.11%) in the extended session after the announcement.
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