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Acadia Pharmaceuticals Inc. (ACAD - Free Report) is a biopharmaceutical company focused on developing innovative medicines to address unmet medical needs in central nervous system (CNS) disorders.
The company’s lead marketed product, Nuplazid (pimavanserin), is the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. The drug was launched in May 2016. The drug has shown strong uptake since its launch. Nuplazid sales have been witnessing consistent year-over-year growth.
In March 2023, Acadia received FDA approval for its second drug, trofinetide, or the treatment of Rett syndrome in adult and pediatric patients aged two years and older. The drug is marketed in the United States under the brand name, Daybue.
The approval of Daybue was a huge boost for the company. In the first full quarter of commercialization following the April 2023 launch, Daybue recorded net product sales of $66.9 million. Incremental revenues from Daybue sales are expected to reduce the burden on Nuplazid sales for revenues.
Acadia had initially received exclusive rights to develop and commercialize trofinetide in North America from Neuren in 2018. However, Neuren had retained rights to develop and commercialize trofinetide for all indications outside North America.
Following the deal to expand the current licensing agreement with Neuren in July 2023, Acadia acquired rights to market trofinetide outside North America along with exclusive global rights to Neuren’s development candidate, NNZ-2591, in Rett syndrome and Fragile X syndrome.
Over the past year, shares of Acadia have skyrocketed 97.1% against the industry’s 14.1% decline.
Image Source: Zacks Investment Research
Recently a U.S. District Court in Delaware issued two rulings strongly in favor of Acadia for its patent for Nuplazid.
The favorable judgments from the court reaffirm the innovation in developing new treatments for disorders with high unmet needs. Together, these judgments are expected to preserve Nuplazid’s sales growth potential in the future due to the absence of generic alternatives in the market.
The company is currently evaluating Nuplazid in schizophrenia-negative symptoms.
A potential approval of the expanded indication of Nuplazid will further boost the drug’s sales.
Besides its marketed portfolio of drugs, ACAD’s efforts to expand its portfolio beyond Nuplazid have also been commendable.
Acadia recently initiated a phase III COMPASS study evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS). Subject to the success of the phase III COMPASS PWS study, the company plans to submit a new drug application for the treatment of hyperphagia in PWS to the FDA. ACAD acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022.
Acadia is also developing ACP-204, another investigational candidate, as a potential treatment for Alzheimer’s disease psychosis (ADP). In the fourth quarter of 2023, ACAD announced initiating a mid-stage study to evaluate the safety and efficacy of its investigational candidate, ACP-204, in the treatment of hallucinations and delusions associated with ADP.
Possible approvals of any of these drugs in the future will be a massive boost to the company’s revenues, significantly reducing the current dependence on Nuplazid for income generation. The company’s commercial portfolio will also have expanded in the event of more drugs getting approved.
Despite the encouraging performance of Acadia’s marketed products along with a strong pipeline, the company’s sole dependence on Nuplazid for growth is a concern.
Although the company now markets Daybue for Rett Syndrome, its uptake will take time, thus, creating heavy dependence on Nuplazid for the time being. Any regulatory setback for Nuplazid will hurt the company’s prospects in future quarters. Other pipeline candidates are also still quite some time away from commercialization.
Moreover, the company faces serious competition from other players in the market developing therapies for CNS indications, an example being Axsome Therapeutics (AXSM - Free Report) . Axsome has a core CNS product candidates portfolio, comprising AXS-05, AXS-07, AXS-12 and AXS-14, which is being developed for multiple CNS indications.
Last year, the FDA approved Axsome's Auvelity (AXS-05) for the treatment of adults with major depressive disorder. A prospective approval for Axsome’s other candidates will create significant competition for Acadia’s Nuplazid and other products.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. Over the past year, shares of PBYI have risen 2.8%.
PBYI’s earnings beat estimates in three of the last four quarters and missed the same once, delivering an average surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have risen 16.5%.
ADMA's earnings beat estimates in three of the trailing four quarters and met the mark once, delivering an average surprise of 63.57%.
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Acadia's (ACAD) Nuplazid Sales Drive Growth Amid Competition
Acadia Pharmaceuticals Inc. (ACAD - Free Report) is a biopharmaceutical company focused on developing innovative medicines to address unmet medical needs in central nervous system (CNS) disorders.
The company’s lead marketed product, Nuplazid (pimavanserin), is the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. The drug was launched in May 2016. The drug has shown strong uptake since its launch. Nuplazid sales have been witnessing consistent year-over-year growth.
In March 2023, Acadia received FDA approval for its second drug, trofinetide, or the treatment of Rett syndrome in adult and pediatric patients aged two years and older. The drug is marketed in the United States under the brand name, Daybue.
The approval of Daybue was a huge boost for the company. In the first full quarter of commercialization following the April 2023 launch, Daybue recorded net product sales of $66.9 million. Incremental revenues from Daybue sales are expected to reduce the burden on Nuplazid sales for revenues.
Acadia had initially received exclusive rights to develop and commercialize trofinetide in North America from Neuren in 2018. However, Neuren had retained rights to develop and commercialize trofinetide for all indications outside North America.
Following the deal to expand the current licensing agreement with Neuren in July 2023, Acadia acquired rights to market trofinetide outside North America along with exclusive global rights to Neuren’s development candidate, NNZ-2591, in Rett syndrome and Fragile X syndrome.
Over the past year, shares of Acadia have skyrocketed 97.1% against the industry’s 14.1% decline.
Image Source: Zacks Investment Research
Recently a U.S. District Court in Delaware issued two rulings strongly in favor of Acadia for its patent for Nuplazid.
The favorable judgments from the court reaffirm the innovation in developing new treatments for disorders with high unmet needs. Together, these judgments are expected to preserve Nuplazid’s sales growth potential in the future due to the absence of generic alternatives in the market.
The company is currently evaluating Nuplazid in schizophrenia-negative symptoms.
A potential approval of the expanded indication of Nuplazid will further boost the drug’s sales.
Besides its marketed portfolio of drugs, ACAD’s efforts to expand its portfolio beyond Nuplazid have also been commendable.
Acadia recently initiated a phase III COMPASS study evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS). Subject to the success of the phase III COMPASS PWS study, the company plans to submit a new drug application for the treatment of hyperphagia in PWS to the FDA. ACAD acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022.
Acadia is also developing ACP-204, another investigational candidate, as a potential treatment for Alzheimer’s disease psychosis (ADP). In the fourth quarter of 2023, ACAD announced initiating a mid-stage study to evaluate the safety and efficacy of its investigational candidate, ACP-204, in the treatment of hallucinations and delusions associated with ADP.
Possible approvals of any of these drugs in the future will be a massive boost to the company’s revenues, significantly reducing the current dependence on Nuplazid for income generation. The company’s commercial portfolio will also have expanded in the event of more drugs getting approved.
Despite the encouraging performance of Acadia’s marketed products along with a strong pipeline, the company’s sole dependence on Nuplazid for growth is a concern.
Although the company now markets Daybue for Rett Syndrome, its uptake will take time, thus, creating heavy dependence on Nuplazid for the time being. Any regulatory setback for Nuplazid will hurt the company’s prospects in future quarters. Other pipeline candidates are also still quite some time away from commercialization.
Moreover, the company faces serious competition from other players in the market developing therapies for CNS indications, an example being Axsome Therapeutics (AXSM - Free Report) . Axsome has a core CNS product candidates portfolio, comprising AXS-05, AXS-07, AXS-12 and AXS-14, which is being developed for multiple CNS indications.
Last year, the FDA approved Axsome's Auvelity (AXS-05) for the treatment of adults with major depressive disorder. A prospective approval for Axsome’s other candidates will create significant competition for Acadia’s Nuplazid and other products.
ACADIA Pharmaceuticals Inc. Price and Consensus
ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote
Zacks Rank and Stocks to Consider
Acadia currently has a Zacks Rank #3 (Hold).
Some better-ranked drug/biotech stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. Over the past year, shares of PBYI have risen 2.8%.
PBYI’s earnings beat estimates in three of the last four quarters and missed the same once, delivering an average surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have risen 16.5%.
ADMA's earnings beat estimates in three of the trailing four quarters and met the mark once, delivering an average surprise of 63.57%.