Goldman Sachs Downgrades Acadia Pharmaceuticals (ACAD) to Neutral, 'Looking for clarity on forward path from Type A meeting'
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Goldman Sachs analyst Salveen Richter downgraded Acadia Pharmaceuticals (NASDAQ: ACAD) from Buy to Neutral with a price target of $25.00 (from $73.00).
The analyst comments "This morning, ACAD announced that it had received a complete response letter (CRL) from the FDA for its sNDA for Nuplazid in dementia related psychosis (DRP), which was unsurprising given the prior announcement on unidentified deficiencies with the application. Despite prior alignment with the agency on the trial design and proposed study population, the FDA cited a lack of benefit demonstrated for Nuplazid across the various dementia subtypes (the trial was not powered to detect statistical changes; details within). We await clarity regarding next steps (ACAD has stated that it is planning to request a Type A meeting to understand the rationale for the decision and to make a case for the strong benefit/risk profile in the broader DRP population); however, we expect the base case is now for an additional pivotal trial which could delay commercial launch by about three years, while noting the evolving competitive landscape that could limit ACAD's first-mover advantage. Given the setback, we now see a lack of meaningful near-term value drivers and downgrade ACAD to Neutral, lowering our 12-month PT to $25 from $73."
Shares of Acadia Pharmaceuticals closed at $25.59 yesterday.
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Create E-mail Alert Related CategoriesAnalyst Comments, Analyst PT Change, Downgrades
Related EntitiesGoldman Sachs, FDA
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