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Acadia (ACAD) Stock Up on FDA's Action Date for Nuplazid sNDA

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Acadia Pharmaceuticals Inc. ACAD announced that it has received the action date from the FDA related to its resubmitted supplemental New Drug Application (sNDA) for pimavanserin to treat hallucinations and delusions associated with Alzheimer’s disease psychosis (“ADP”).

The regulatory body has set a target action date of Aug 4, 2022. The FDA’s Division of Psychiatry plans to hold an advisory committee meeting owing to its review of the sNDA.

Shares of Acadia were up 10.2% on Wednesday following the announcement of the above news. In fact, the stock has rallied 10.5% so far this year against the industry’s decline of 19.4%.

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Last month, Acadia resubmitted the sNDA to the FDA for pimavanserin for the treatment of hallucinations and delusions associated with ADP.

The resubmitted sNDA was based on positive data from two placebo-controlled studies — the pivotal phase III HARMONY study and the -019 study. Both studies have prospectively met their primary endpoints.

In April 2021, the FDA issued a complete response letter (“CRL”) to the sNDA for Nuplazid for the treatment of hallucinations and delusions associated with dementia-related psychosis or DRP.

The CRL indicated that the FDA had completed its review of the application and had decided that it 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.

Pimavanserin is currently approved under the trade name Nuplazid in the United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

In 2021, Nuplazid recorded sales worth $484.1 million, reflecting an increase of 10% year over year. A potential label expansion is likely to boost sales of the drug in 2022 and beyond.

Zacks Rank & Stocks to Consider

Acadia currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Athersys, Inc. ATHX, Kaleido Biosciences, Inc. KLDO and Vertex Pharmaceuticals Incorporated VRTX, 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.

Athersys’ earnings estimates have been revised 21.7% upward for 2022 over the past 60 days.

Earnings of Athersys have surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.

Kaleido Biosciences’ loss per share estimates have narrowed 11.3% for 2022 over the past 60 days.

Earnings of Kaleido Biosciences have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

Vertex’s earnings estimates have been revised 8.4% upward for 2022 over the past 60 days. The VRTX stock has gained 9% year to date.

Vertex’s earnings have surpassed estimates in each of the trailing four quarters.


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