Raymond James Downgrades Acadia Pharmaceuticals (ACAD) to Outperform
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Raymond James analyst Danielle Brill downgraded Acadia Pharmaceuticals (NASDAQ: ACAD) from Strong Buy to Outperform with a price target of $35.00 (from $65.00).
The analyst comments "We are downgrading ACAD from Strong Buy to Outperform following today’s disclosure that the FDA found deficiencies in their sNDA filing that preclude labeling discussions for Nuplazid in dementia related psychosis (DRP). We have no good guesses as to what “deficiencies” the FDA found, but one thing is quite clear – the regulatory outlook for DRP suddenly appears quite dire. We believe ACAD management was as transparent as possible in tonight’s update, but given the lack of feedback from the agency to their multiple inquiries (since being notified on March 3), it unfortunately looks like a CRL is now the most likely outcome for Nuplazid by its April 3 PDUFA date. Considering Nuplazid was granted breakthrough therapy designation (BTD), and nothing major was ever discussed/ highlighted by the agency in prior interactions throughout the review process, we remain hopeful that the deficiencies are minor and will only result in an approval delay. Still, it is possible that the deficiency is something more substantial (requiring another study)."
Shares of Acadia Pharmaceuticals closed at $29.40 yesterday.
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Create E-mail Alert Related CategoriesAnalyst Comments, Analyst PT Change, Downgrades
Related EntitiesRaymond James, PDUFA, FDA
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