Specialty pharmaceuticals company, Amneal Pharmaceuticals (NYSE: AMRX) tanked in pre-market trading at the time of writing on Wednesday after the company announced that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). This was in relation to AMRX’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease.
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The letter indicated that based on pharmacokinetic studies, while an “adequate scientific bridge” was established for the safety of one ingredient, levodopa (LD), “it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information.” The company’s press release stated that the FDA’s letter “did not identify any issues with respect to the efficacy or manufacturing of IPX203. Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward.”
This news came even as Amneal launched an authorized generic for Xyrem (sodium oxybate) in the U.S. and received the FDA’s approval for five new complex generics in Q2 and is well on track to launch more than 30 new generic products this year.
Analysts are bullish about AMRX stock with a Strong Buy consensus rating based on four Buys and one Hold.
