Analysts Remain Bullish on Acadia Pharma Despite Drug Approval Delay

ACADIA Pharmaceuticals Inc (NASDAQ:ACAD) is making headlines with the sudden announcement of the CEO’s retirement and an application delay for the company’s leading drug. Acadia focuses on developing treatment for neurological and central nervous system disorders.

On March 11, CEO Uli Hacksell abruptly retired after 16 years with the company. He will also be retiring from his position on the board of directors. Acadia applauded Hacksell’s tenure in a press release, noting that Acadia “has grown from a small startup to a fast growing biopharmaceutical company with innovative drug candidates” under his leadership. CFO Steve David will take over immediately as the interim CEO.

Also on March 11, Acadia announced a delay in submitting the New Drug Application for Nuplazid. The application was scheduled for submission in the first quarter of 2015 but is being pushed back to the second half of 2015. Nuplazid is intended to treat Parkinson’s disease psychosis and is Acadia’s primary pipeline drug. The drug already reported successful results in a Phase III clinical trial. Acadia noted that the prudent delay is necessary to complete the application and emphasized that the “change in submission timing is not a result of any change to NUPLAZID’s clinical or safety profile, nor is it a result of any interaction with or request for information from the FDA.”

On March 12, analyst Alan Carr of Needham & Company reiterated a Buy rating on Acadia Pharmaceuticals and lowered his price target from $40 to $38. Carr made the rating in light of Hacksell’s retirement and Nuplazid’s delay. In response to Nuplazid’s delay, he noted, “[Management] admitted that preparations for FDA review were inadequate. Changes have been made to address the matter, including hiring additional staff and external consultants as well as shifts in senior management responsibilities.” Carr emphasized that the delay “is not tied to any new communication from the FDA or any new safety data… Our enthusiasm for the drug and its commercial potential as an antipsychotic is unchanged.”

Alan Carr has rated Acadia Pharma 10 times since March 2012 with a 100% success rate recommending the pharmaceutical company and an impressive +91.5% average return per ACAD recommendation. Overall, Carr has a 76% success rate recommending stocks with a +44.3% average return per recommendation.



Separately on March 12, analyst Andrew S. Fein of H.C. Wainright maintained a Buy rating on Acadia Pharmaceuticals with a price target of $50. Fein was not fazed by Nuplazid’s delay because the drug still has “Breakthrough Therapy designation from the FDA,” which will allows for “rolling NDA submission with communication/feedback at every step.” Furthermore, Fein noted that “since there are no changes to the formulation or safety and efficacy data of the drug, nothing has changed with the agency’s regard for the drug, and in our view, its approvability.” The analyst concluded, “We look forward to further granularity on such potential developments, which would remind everyone that none of the fundamental components of the bull thesis have changed.”

Andrew Fein has rated Acadia once before and earned a +22.6% return. Overall, Fein has a 69% success rate recommending stocks with a +36.5% average return per recommendation.



On average, the top analyst consensus for Acadia Pharmaceuticals on TipRanks is Strong Buy.