Acadia Pharmaceuticals shares lead first-market losers after FDA detects undisclosed “deficiencies” in NDA

Shares of Acadia Pharmaceuticals Inc. ACAD,
-47.68%
fell 42.1% at the pace of all pre-market declines on Tuesday, following the company’s announcement that the Food and Drug Administration found undisclosed deficiencies in its supplemental application for new drugs ( NDA) for pimavanserin, a treatment for hallucinations and delusions associated with dementia-related psychosis. . The company said Monday afternoon that the FDA’s identification of deficiencies prevented the debate on labeling and post-marketing requirements. But the FDA did not specify the deficiencies it identified, Acadia said. This led Raymond James analyst Danielle Brill to downgrade Acadia to surpass its strong buy and lower the price target to $ 35 from $ 65. “We don’t have good guesswork about what‘ deficiencies ’the FDA found, but one thing is clear: the regulatory prospects for DRP suddenly seem serious,” Brill wrote in a note to customers. Paul Matteis of Stifel Nicolaus reduced his rating to keep the purchase and its target price to $ 27 from $ 68. “Not defending action out of weakness; DRP’s prospects seem bleak and difficult to trust,” Matteis wrote. Shares, which are on track to open at the lowest price observed during regular sessions since September 2019, have lost 12.5% ​​in the last three months to Monday, while the S&P 500 SPX,
+ 1.85%
has gained 4.0%.

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