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ACADIA (ACAD) Gets CRL From FDA for Nuplazid sNDA, Shares Down

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ACADIA Pharmaceuticals Inc. (ACAD - Free Report) announced that the FDA has issued a complete response letter (“CRL”) to its supplemental new drug application (sNDA) for Nuplazid (pimavanserin). The sNDA sought approval for label expansion of Nuplazid for the treatment of hallucinations and delusions associated with dementia-related psychosis (“DRP”).

The CRL was issued to indicate that the regulatory body has completed its review of the application and decided that it cannot be approved in its present form as it lacks statistical significance in some of the subgroups of dementia. Moreover, there were insufficient numbers of patients with certain less common dementia subtypes, which was considered as lack of substantial evidence of effectiveness to support approval.

Further, the phase II Alzheimer’s disease psychosis study -019, which was a supportive study in the sNDA filing, was not adequate and well controlled.

Shares of ACADIA were down 17.2% following the announcement of the news on Monday. In fact, the stock has plunged 60.4% so far this year compared with its industry’s decrease of 4.1%.

price chart for ACAD


Meanwhile, ACADIA management stated that it will immediately request a Type A meeting with the FDA to address the CRL and determine an expeditious path forward for the approval of Nuplazid in DRP.

The above CRL from the FDA was expected, as last month, the federal agency identified deficiencies in the sNDA seeking approval of Nuplazid for DRP, which meant a delay in approval for the expanded use. The FDA’s decision was expected on Apr 3, 2021.

We remind investors that ACADIA’s only marketed drug, Nuplazid, is the first and the only FDA-approved treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Nuplazid recorded sales worth $441.7 million in 2020, reflecting an increase of 30.3% year over year. The company is developing Nuplazid to treat other neuropsychiatric conditions. A potential label expansion is likely to boost sale of the drug in 2021 and beyond.

Zacks Rank & Stocks to Consider

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

Better-ranked stocks in the biotech sector include Celldex Therapeutics, Inc. (CLDX - Free Report) , Repligen Corporation (RGEN - Free Report) and Nabriva Therapeutics AG (NBRV - Free Report) , 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.

Celldex’s loss per share estimates have narrowed 3.4% for 2021 and 15.4% for 2022 over the past 60 days. The stock has rallied 27.9% year to date.

Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has increased 4.6% year to date.

Nabriva’s loss per share estimates have narrowed 45.8% for 2021 and 50.9% for 2022 over the past 60 days.

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