AMRX - Amneal receives Complete Response Letter for Parkinson's candidate

2023-07-03 14:34:31 ET

• The US FDA has issued a Complete Response Letter to Amneal Pharmaceuticals ( NYSE: AMRX ) for Parkinson's disease candidate IPX203.
• The stock is down ~5% in after-hours trading Monday.
• The agency said that an adequate scientific bridge was not established for the safety of one of the drug's two active ingredients, carbidopa. It was established for levodopa.
• Amneal ( AMRX ) noted that the letter did not find any issues with efficacy or manufacturing.
• The company said it will work with the FDA to address its concerns. It added the letter doesn't impact its 2023 financial guidance .
• IPX203 is novel, oral, extended-release formulation of carbidopa and levodopa, two of the most commonly used medicines for Parkinson's.
• Seeking Alpha's Quant Rating views Amneal ( AMRX ) as a hold.

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