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Acadia (ACAD) Rises 35% on Positive Patent Ruling for Nuplazid
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Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that the U.S. District Court in Delaware passed a judgment strongly in favor of the company in its litigation against MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals, Inc. and other abbreviated new drug application filers.
The court granted summary judgment to Acadia confirming the validity of the '740 composition of matter patent for its lead drug for Nuplazid (pimavanserin).
The ruling prevents generic drug manufacturers, like MSN Laboratories, from making low-cost generic versions of Acadia’s lead-marketed drug, Nuplazid.
The ‘740 composition of matter patent protects Nuplazid exclusivity into 2030.
Acadia’s stock surged 34.5% in the last trading session as investors expect Nuplazid sales to maintain its growth trajectory in the absence of any generic alternatives available in the market. Year to date, the shares of Acadia have surged 78.8% against the industry’s 19.2% loss.
Image Source: Zacks Investment Research
Acadia believes that the favorable judgment from the court reaffirms its innovation in developing new treatments for disorders with high unmet needs.
Nuplazid is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. It 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 in the U.S. market and has shown strong uptake since. In the nine months ended Sep 30, 2023, revenues generated from Nuplazid sales, accounting for 82% of Acadia’s total revenues, were recorded at $405 million, representing a 6% increase over the year-ago figure.
Acadia markets two forms of Nuplazid, a 34mg capsule and a 10mg tablet, which are also protected by issued patents. The 34mg capsule is protected by multiple issued formulation patents until 2038, while the 10mg tablet is protected by an issued method of use patent until 2037.
Notably, Acadia is also evaluating Nuplazid in schizophrenia-negative symptoms. Label expansion of the drug, subject to successful development and commercialization, will further boost revenues for the company.
In a separate press release, Acadia announced a second positive ruling from the U.S. District Court in Delaware. The court has also issued a claim construction order in favor of the company regarding its ‘721 formulation patent for Nuplazid.
A claim construction order is a process in which courts interpret the meaning and scope of a patent’s claims. Per the outcomes of the proceedings, the court ruled in favor of Acadia on all the disputed claim construction points, adopting the company’s interpretation of key disputed terms of the patent.
Acadia also reported that, following the recent proceedings, a pre-scheduled claims construction hearing had been canceled by the court. The next hearing date is scheduled for December 2024.
Acadia also currently markets another drug, Daybue (trofinetide), in the United States, which was approved by the FDA in May 2023 to treat Rett syndrome in adult and pediatric patients two years of age and older.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 5.4%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 3.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 65.7%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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Acadia (ACAD) Rises 35% on Positive Patent Ruling for Nuplazid
Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that the U.S. District Court in Delaware passed a judgment strongly in favor of the company in its litigation against MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals, Inc. and other abbreviated new drug application filers.
The court granted summary judgment to Acadia confirming the validity of the '740 composition of matter patent for its lead drug for Nuplazid (pimavanserin).
The ruling prevents generic drug manufacturers, like MSN Laboratories, from making low-cost generic versions of Acadia’s lead-marketed drug, Nuplazid.
The ‘740 composition of matter patent protects Nuplazid exclusivity into 2030.
Acadia’s stock surged 34.5% in the last trading session as investors expect Nuplazid sales to maintain its growth trajectory in the absence of any generic alternatives available in the market. Year to date, the shares of Acadia have surged 78.8% against the industry’s 19.2% loss.
Image Source: Zacks Investment Research
Acadia believes that the favorable judgment from the court reaffirms its innovation in developing new treatments for disorders with high unmet needs.
Nuplazid is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. It 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 in the U.S. market and has shown strong uptake since. In the nine months ended Sep 30, 2023, revenues generated from Nuplazid sales, accounting for 82% of Acadia’s total revenues, were recorded at $405 million, representing a 6% increase over the year-ago figure.
Acadia markets two forms of Nuplazid, a 34mg capsule and a 10mg tablet, which are also protected by issued patents. The 34mg capsule is protected by multiple issued formulation patents until 2038, while the 10mg tablet is protected by an issued method of use patent until 2037.
Notably, Acadia is also evaluating Nuplazid in schizophrenia-negative symptoms. Label expansion of the drug, subject to successful development and commercialization, will further boost revenues for the company.
In a separate press release, Acadia announced a second positive ruling from the U.S. District Court in Delaware. The court has also issued a claim construction order in favor of the company regarding its ‘721 formulation patent for Nuplazid.
A claim construction order is a process in which courts interpret the meaning and scope of a patent’s claims. Per the outcomes of the proceedings, the court ruled in favor of Acadia on all the disputed claim construction points, adopting the company’s interpretation of key disputed terms of the patent.
Acadia also reported that, following the recent proceedings, a pre-scheduled claims construction hearing had been canceled by the court. The next hearing date is scheduled for December 2024.
Acadia also currently markets another drug, Daybue (trofinetide), in the United States, which was approved by the FDA in May 2023 to treat Rett syndrome in adult and pediatric patients two years of age and older.
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 worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 each 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 remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 5.4%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 3.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 65.7%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.