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Shares of Acadia Pharma (NASDAQ:ACAD) are seeing heavy action Wednesday morning after the publication of FDA briefing documents on the company’s pimavanserin ADP submission.
Commenting on the news, Stifel analyst Paul Matteis notes that the published documents “align with our expectations”.
He elaborates: “FDA is critical of the ph2 ADP results for pimavanserin, bringing up all the bear cases: (1) validity of the primary endpoint, (2) placebo possibly driving the effect at week-6, (3) lack of secondary-endpoint corroboration and (4) various protocol deviations. The agency also reiterated their view that the DRP positive outcome at the interim was driven by a robust response in the Parkinson’s population, whereas the ADP subgroup, though directional, had a nominal p-value of 0.28 with other noted confounds to various post-hoc analyses. On the more positive side that does arguably leave the door open some: the questions posed to the panel are pretty boilerplate, and at the very least, aren’t negatively weighted or inherently biased.”
The analyst is therefore “confused by stock reaction” and believes “stock bounce reflects low expectations going in, and no unexpected surprises” but reiterates that “we do not view these documents as supportive”
Shares of ACAD are trading around $18 on Wednesday, up over 10%.
