Shares of Acadia Pharmaceuticals Inc. ACAD,
fell 42.1% to dampen all premarket declines Tuesday, in the wake of the company’s announcement that the Food and Drug Administration found undisclosed flaws in its additional New Drug Application (NDA) for pimavanserin, a treatment for hallucinations and delusions associated with dementia-related psychosis. The company said late Monday that the FDA’s identification of deficiencies precluded discussion of labeling and post-marketing requirements. But the FDA has not specified the deficiencies it identified, Acadia said. That prompted Raymond James analyst Danielle Brill to downgrade Acadia to outperform a strong buy and drop the price target from $ 65 to $ 35. The thing is clear: the regulation prospects for DRP suddenly seem pretty dire, “Brill wrote in a note to customers. Paul Matteis of Stifel Nicolaus downgraded his buy rating and price target from $ 68 to $ 27. “Don’t defend the stock based on weakness; the outlook for DRP looks bleak, it’s hard for us to be confident”, wrote Matteis. The stock, which is on track to open at its lowest price since September 2019 during regular session hours, has lost 12.5% in the past three months through Monday, while the S&P 500 SPX,
has gained 4.0%.