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FDA Panel Votes Against Acadia (ACAD) sNDA for Nuplazid

·3 min read

Acadia Pharmaceuticals Inc. ACAD announced that the FDA’s Psychopharmacologic Drugs Advisory Committee (“PDAC”) has not voted in favor of the supplemental new drug application (sNDA) for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer's disease psychosis (“ADP”).

The PDAC voted nine to three, thus not supporting the claim that pimavanserin is effective in the treatment of hallucinations and delusions for the ADP patient population. Earlier, the FDA had asked the committee for advice and recommendations regarding the evidence that pimavanserin is effective for the given indication.

The FDA’s decision date for the sNDA is Aug 4. Though the FDA is not completely bound by the PDAC’s recommendations, it usually follows the same.

Shares of Acadia have lost 16.4% so far this year compared with the industry’s decline of 28.1%.

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In a separate press release, Acadia announced that the Nasdaq halted trading ACAD’s common shares on Jun 17, ahead of the PDAC’s review of the resubmitted sNDA for Nuplazid for the treatment of hallucinations and delusions associated with ADP.

Acadia shares are expected to be down when it resumes trading on Monday, Jun 20.

Last week, shares of Acadia gained briefly after the FDA issued the briefing documents ahead of its Advisory Committee meeting on Jun 17.

We remind investors that the FDA had issued a complete response letter ("CRL") to the sNDA for Nuplazid in April 2021.

The CRL indicated that the FDA had decided that Nuplazid could not be approved in its then-present form as it lacked statistical significance in some of the subgroups of dementia. Moreover, there was an insufficient number of patients with certain less common dementia subtypes, which was considered as a lack of substantial evidence of effectiveness to support approval. The CRL also stated that the phase II Alzheimer’s disease psychosis study, a supportive study in the sNDA filing, was inadequate and not well controlled.

Nuplazid is currently approved in the United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The drug generated sales worth $115.5 million in the first quarter of 2022, reflecting an increase of 8% year over year. A potential label expansion is likely to boost sales of the drug in the days ahead.

Zacks Rank & Stocks to Consider

Acadia currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. LPTX, Aeglea BioTherapeutics, Inc. AGLE and Precision BioSciences, Inc. DTIL, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.

Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.

Aeglea BioTherapeutics’ loss per share estimates narrowed 19.4% for 2022 and 37.5% for 2023 in the past 60 days.

Earnings of Aeglea BioTherapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average

Precision BioSciences’ loss per share estimates narrowed 21.7% for 2022 and 31.4% for 2023 in the past 60 days.

Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.


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