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ACADIA (ACAD) Falls as FDA Finds Deficiencies in Nuplazid sNDA
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ACADIA Pharmaceuticals Inc. (ACAD - Free Report) announced that the FDA has identified deficiencies in the supplemental new drug application (sNDA) seeking approval of Nuplazid (pimavanserin) for a new indication.
Please note that Nuplazid is currently under review in the United States for treating hallucinations and delusions associated with dementia-related psychosis (“DRP”). The FDA’s decision is expected on Apr 3, 2021.
The regulatory body has not yet specified the deficiencies which prevent discussion of labeling and post-marketing requirements on Nuplazid for the given indication. ACADIA is looking to work with the FDA authorities to learn the nature of the deficiencies and rectify them.
However, such a notification from the FDA could imply that the PDUFA action date might get extended in due course, which means a delay in approval for the expanded use.
Shares of ACADIA were down 6.5% on Monday following the announcement of the news. In fact, the stock has declined 13.9% so far this year compared with the industry’s decrease of 1.7%.
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.
In 2020, Nuplazid recorded sales worth $441.7 million, reflecting an increase of 30.3% year over year. A potential label expansion is likely to boost sale of the drug in 2021 and beyond.
Other studies on Nuplazid include the phase III ADVANCE study for treating negative symptoms of schizophrenia. Nuplazid is also being evaluated in the phase III CLARITY study as an adjunctive treatment of major depressive disorder.
Stoke Therapeutics’ loss per share estimates have narrowed 2.1% for 2021 over the past 60 days.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 over the past 60 days.
Nabriva’s loss per share estimates have narrowed 8.9% for 2021 over the past 60 days.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
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ACADIA (ACAD) Falls as FDA Finds Deficiencies in Nuplazid sNDA
ACADIA Pharmaceuticals Inc. (ACAD - Free Report) announced that the FDA has identified deficiencies in the supplemental new drug application (sNDA) seeking approval of Nuplazid (pimavanserin) for a new indication.
Please note that Nuplazid is currently under review in the United States for treating hallucinations and delusions associated with dementia-related psychosis (“DRP”). The FDA’s decision is expected on Apr 3, 2021.
The regulatory body has not yet specified the deficiencies which prevent discussion of labeling and post-marketing requirements on Nuplazid for the given indication. ACADIA is looking to work with the FDA authorities to learn the nature of the deficiencies and rectify them.
However, such a notification from the FDA could imply that the PDUFA action date might get extended in due course, which means a delay in approval for the expanded use.
Shares of ACADIA were down 6.5% on Monday following the announcement of the news. In fact, the stock has declined 13.9% so far this year compared with the industry’s decrease of 1.7%.
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.
In 2020, Nuplazid recorded sales worth $441.7 million, reflecting an increase of 30.3% year over year. A potential label expansion is likely to boost sale of the drug in 2021 and beyond.
Other studies on Nuplazid include the phase III ADVANCE study for treating negative symptoms of schizophrenia. Nuplazid is also being evaluated in the phase III CLARITY study as an adjunctive treatment of major depressive disorder.
Zacks Rank & Stocks to Consider
ACADIA currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Stoke Therapeutics, Inc. (STOK - Free Report) , Repligen Corporation (RGEN - Free Report) and NabrivaTherapeutics AG , 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.
Stoke Therapeutics’ loss per share estimates have narrowed 2.1% for 2021 over the past 60 days.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 over the past 60 days.
Nabriva’s loss per share estimates have narrowed 8.9% for 2021 over the past 60 days.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>