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Key Catalysts for ACADIA Pharmaceuticals

06/03/2020 5:00 am EST

Focus: HEALTHCARE

John McCamant

Editor, Medical Technology Stock Letter

ACADIA Pharmaceuticals (ACAD) is doing a very good job of executing during the COVID-19 crisis with solid Nuplazid sales, FDA timelines intact and a nice pipeline deal, notes John McCamant, editor of The Medical Technology Stock Letter — and a participating speaker at MoneyShow's Virtual Event on June 10-12.

ACADIA reported first quarter 2020 results including Nuplazid net sales of $90.1 million, which was right at the consensus estimate. The company lowered previous FY20 guidance slightly from $440-470 million to $420-450 million reflecting anticipated COVID-19 impact. 

Importantly, the dementia-related psychosis (DRP) sNDA submission is still anticipated this summer following FDA discussions in the first half of 2020, with potential approval by year-end thanks to being granted Priority Review.

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DRP is key to future Nuplazid growth. We expect ACADIA to seek a broad label based on consistently positive Phase III HARMONY results across multiple dementia subtypes. ACAD expects priority review and remains committed to launch by year end.

Meanwhile, the firm announced that following positive feedback from the FDA, it plans to combine its CLARITY-2 and CLARITY-3 Phase III studies evaluating pimavanserin for the adjunctive treatment of major depressive disorder (MDD) into one study with a pre-specified statistical analysis plan.

If positive, the results from the combined study, along with the positive results from the previously announced pivotal CLARITY study, would form the basis for a supplemental new drug application for pimavanserin in the adjunctive treatment of MDD.

Business development remains an ACAD priority to build out the early-stage pipeline, and the lead candidate from Vanderbilt is in Phase I trials. The DRP sNDA submission and subsequent approval represents a significant catalyst for the company. The stock is rated a buy.

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