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Acadia's (ACAD) Nuplazid Drives Growth, Pipeline Setbacks a Woe
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Acadia Pharmaceuticals (ACAD - Free Report) is a commercial-stage company focused on developing innovative medicines to address unmet medical needs in central nervous system (CNS) disorders and rare diseases. ACAD’s commercial portfolio comprises two marketed drugs — Nuplazid (pimavanserin) and Daybue (trofinetide).
Acadia’s first drug, Nuplazid, is the first and the only FDA-approved treatment for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. Its second product, Daybue, was approved by the FDA in March 2023 for the treatment of Rett syndrome in adult and pediatric patients aged two years and older.
Daybue is the first and only drug to be approved by the FDA for the given indication. The drug was launched in the United States in April 2023.
Revenues generated from the sales of Nuplazid are the majority contributor to Acadia’s top line. In the first quarter of 2024, Nuplazid sales increased 10% year over year to $129.9 million, driven by improvements in new patient starts and higher price benefits.
Daybue sales help generate incremental revenues for the company, which is expected to reduce the burden on Nuplazid sales for revenues. This is a huge boost for Acadia. Daybue recorded net product sales of $75.9 million in its third full quarter since its launch.
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 of 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.
Year to date, shares of ACAD have plunged 42.4% compared with the industry’s 2.7% decline.
Image Source: Zacks Investment Research
In late 2023, the 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.
Besides the performance of its marketed portfolio of drugs, Acadia’s efforts to expand its portfolio beyond Nuplazid have also been commendable.
Acadia has 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 that it has initiated 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, creating additional streams of revenues for the company, while further reducing dependency on Nuplazid sales. Acadia’s commercial portfolio will also have expanded in the event of more drugs getting approved.
However, we would like to remind the investors that the company recently suffered a massive setback after the failure of its phase III ADVANCE-2 study evaluating pimavanserin for the treatment of negative symptoms of schizophrenia. Based on the disappointing outcome of the study, the company has decided not to pursue any further clinical studies with pimavanserin. Such setbacks do not bode well for the company and are detrimental to the stock.
Moreover, it is not be noted that although Acadia now markets Daybue for Rett Syndrome, its uptake will take time, thus, creating heavy dependence on Nuplazid for the time being. Having stopped clinical studies with pimavanserin, the company is now focusing on its pipeline candidates, which are quite some time away from commercialization. In the meantime, any setbacks in their developmental process will adversely affect the stock.
Acadia 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 are 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 Arcutis Biotherapeutics’ 2024 loss per share has remained constant at $1.60. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.14. Year to date, shares of ARQT have skyrocketed 233.4%.
Arcutis Biotherapeutics beat estimates in three of the trailing four quarters and missed once, delivering an average earnings surprise of 14.93%.
In the past 30 days, the Zacks Consensus Estimate for Adaptive’s 2024 loss per share has remained constant at $1.29. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.02. Year to date, shares of ADPT have plunged 17.8%.
Adaptive beat estimates in two of the trailing four quarters, matched once and missed on the remaining occasion, delivering an average surprise of 0.65%.
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Acadia's (ACAD) Nuplazid Drives Growth, Pipeline Setbacks a Woe
Acadia Pharmaceuticals (ACAD - Free Report) is a commercial-stage company focused on developing innovative medicines to address unmet medical needs in central nervous system (CNS) disorders and rare diseases. ACAD’s commercial portfolio comprises two marketed drugs — Nuplazid (pimavanserin) and Daybue (trofinetide).
Acadia’s first drug, Nuplazid, is the first and the only FDA-approved treatment for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. Its second product, Daybue, was approved by the FDA in March 2023 for the treatment of Rett syndrome in adult and pediatric patients aged two years and older.
Daybue is the first and only drug to be approved by the FDA for the given indication. The drug was launched in the United States in April 2023.
Revenues generated from the sales of Nuplazid are the majority contributor to Acadia’s top line. In the first quarter of 2024, Nuplazid sales increased 10% year over year to $129.9 million, driven by improvements in new patient starts and higher price benefits.
Daybue sales help generate incremental revenues for the company, which is expected to reduce the burden on Nuplazid sales for revenues. This is a huge boost for Acadia. Daybue recorded net product sales of $75.9 million in its third full quarter since its launch.
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 of 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.
Year to date, shares of ACAD have plunged 42.4% compared with the industry’s 2.7% decline.
Image Source: Zacks Investment Research
In late 2023, the 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.
Besides the performance of its marketed portfolio of drugs, Acadia’s efforts to expand its portfolio beyond Nuplazid have also been commendable.
Acadia has 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 that it has initiated 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, creating additional streams of revenues for the company, while further reducing dependency on Nuplazid sales. Acadia’s commercial portfolio will also have expanded in the event of more drugs getting approved.
However, we would like to remind the investors that the company recently suffered a massive setback after the failure of its phase III ADVANCE-2 study evaluating pimavanserin for the treatment of negative symptoms of schizophrenia. Based on the disappointing outcome of the study, the company has decided not to pursue any further clinical studies with pimavanserin. Such setbacks do not bode well for the company and are detrimental to the stock.
Moreover, it is not be noted that although Acadia now markets Daybue for Rett Syndrome, its uptake will take time, thus, creating heavy dependence on Nuplazid for the time being. Having stopped clinical studies with pimavanserin, the company is now focusing on its pipeline candidates, which are quite some time away from commercialization. In the meantime, any setbacks in their developmental process will adversely affect the stock.
Acadia 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 are 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 Other Stocks to Consider
Acadia currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the drug/biotech industryare Arcutis Biotherapeutics (ARQT - Free Report) and Adaptive Biotechnologies Corporation (ADPT - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Arcutis Biotherapeutics’ 2024 loss per share has remained constant at $1.60. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.14. Year to date, shares of ARQT have skyrocketed 233.4%.
Arcutis Biotherapeutics beat estimates in three of the trailing four quarters and missed once, delivering an average earnings surprise of 14.93%.
In the past 30 days, the Zacks Consensus Estimate for Adaptive’s 2024 loss per share has remained constant at $1.29. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.02. Year to date, shares of ADPT have plunged 17.8%.
Adaptive beat estimates in two of the trailing four quarters, matched once and missed on the remaining occasion, delivering an average surprise of 0.65%.