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Acadia (ACAD) Rises More Than 14% in 3 Months: Here's Why
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Shares of Acadia Pharmaceuticals Inc. (ACAD - Free Report) have risen 14.9% in the past three months against the industry’s decrease of 8.4%.
Last month, the FDA accepted for review Acadia's new drug application (“NDA”) seeking approval of its pipeline candidate, trofinetide, for the treatment of patients with Rett syndrome.
With the FDA granting priority review to the NDA, a decision from the regulatory body is expected on Mar 12, 2023.
This might be a reason for ACAD’s shares to have witnessed an upside during this time frame.
ACAD submitted the NDA for trofinetide to treat Rett Syndrome in July 2022. Rett syndrome is a rare neurological disorder for girls aged between five and 20 years.
Image Source: Zacks Investment Research
Currently, Acadia’s top line solely comprises sales of its only marketed drug, Nuplazid (pimavanserin), in the United States. The drug is approved for treating hallucinations and delusions associated with Parkinson’s disease psychosis.
In August 2022, Acadia received a complete response letter (“CRL”) from the FDA for its resubmitted supplemental new drug application (“sNDA”) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The latest CRL was expected, as in June 2022, the FDA’s Psychopharmacologic Drugs Advisory Committee voted (nine-three) against the sNDA for pimavanserin for treating hallucinations and delusions associated with ADP.
Earlier, the FDA had asked the committee for advice and recommendations regarding the evidence that pimavanserin is effective for the given indication.
We remind investors that the FDA issued a CRL to the Nuplazid sNDA in April 2021.
Upon potential approval, trofinetide can become the second approved drug in Acadia’s portfolio of marketed drugs and lend a significant boost to the company as well as lower its sole dependence on Nuplazid for revenues.
However, competition remains stiff as several other companies, including Axsome Therapeutics (AXSM - Free Report) , are also developing treatments to address various CNS disorders.
In August, the FDA approved Axsome’s lead pipeline candidate AXS-05, with the trade name Auvelity, for the treatment of adults with major depressive disorder.
Axsome also has several other CNS product candidates, namely, AXS-07, AXS-09, AXS-12 and AXS-14, which are being developed for multiple CNS indications. A prospective approval for any of these candidates will induce competition for Acadia and its products.
Estimates for Atara Biotherapeutics’ loss per share have narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
Estimates for ORIC Pharmaceuticals’ loss per share have narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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Acadia (ACAD) Rises More Than 14% in 3 Months: Here's Why
Shares of Acadia Pharmaceuticals Inc. (ACAD - Free Report) have risen 14.9% in the past three months against the industry’s decrease of 8.4%.
Last month, the FDA accepted for review Acadia's new drug application (“NDA”) seeking approval of its pipeline candidate, trofinetide, for the treatment of patients with Rett syndrome.
With the FDA granting priority review to the NDA, a decision from the regulatory body is expected on Mar 12, 2023.
This might be a reason for ACAD’s shares to have witnessed an upside during this time frame.
ACAD submitted the NDA for trofinetide to treat Rett Syndrome in July 2022. Rett syndrome is a rare neurological disorder for girls aged between five and 20 years.
Image Source: Zacks Investment Research
Currently, Acadia’s top line solely comprises sales of its only marketed drug, Nuplazid (pimavanserin), in the United States. The drug is approved for treating hallucinations and delusions associated with Parkinson’s disease psychosis.
In August 2022, Acadia received a complete response letter (“CRL”) from the FDA for its resubmitted supplemental new drug application (“sNDA”) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The latest CRL was expected, as in June 2022, the FDA’s Psychopharmacologic Drugs Advisory Committee voted (nine-three) against the sNDA for pimavanserin for treating hallucinations and delusions associated with ADP.
Earlier, the FDA had asked the committee for advice and recommendations regarding the evidence that pimavanserin is effective for the given indication.
We remind investors that the FDA issued a CRL to the Nuplazid sNDA in April 2021.
Upon potential approval, trofinetide can become the second approved drug in Acadia’s portfolio of marketed drugs and lend a significant boost to the company as well as lower its sole dependence on Nuplazid for revenues.
However, competition remains stiff as several other companies, including Axsome Therapeutics (AXSM - Free Report) , are also developing treatments to address various CNS disorders.
In August, the FDA approved Axsome’s lead pipeline candidate AXS-05, with the trade name Auvelity, for the treatment of adults with major depressive disorder.
Axsome also has several other CNS product candidates, namely, AXS-07, AXS-09, AXS-12 and AXS-14, which are being developed for multiple CNS indications. A prospective approval for any of these candidates will induce competition for Acadia and its products.
Acadia Pharmaceuticals Inc. Price
Acadia Pharmaceuticals Inc. price | Acadia Pharmaceuticals Inc. Quote
Zacks Rank & Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Atara Biotherapeutics, Inc. (ATRA - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Atara Biotherapeutics’ loss per share have narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
Estimates for ORIC Pharmaceuticals’ loss per share have narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.