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ACAD Signs License Deal With Saniona for Rights to Neurology Drug
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Acadia Pharmaceuticals (ACAD - Free Report) announced that it has signed an exclusive worldwide license agreement with Saniona, a Denmark-based clinical-stage biopharmaceutical company, to develop and commercialize SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator.
As its first indication, Acadia plans to study SAN711 for essential tremor, a neurological condition that includes shaking or trembling movements in one or more parts of the body. The company is gearing up to initiate a mid-stage study of the candidate for the essential tremor indication in 2026.
This strategic move aligns with ACAD’s longstanding commitment to delivering innovative therapies for patients with central nervous system disorders. Per the company, essential tremor has lacked innovative treatment options for decades, highlighting a significant unmet need. Leveraging Acadia’s extensive expertise in developing and commercializing advanced therapies for neurological disorders, the company aims to address this gap through its work with SAN711.
Year to date, shares of Acadia have plunged 48.2% compared with the industry’s 7.8% decline.
Image Source: Zacks Investment Research
Per the terms of the licensing agreement, ACAD is liable to pay Saniona an upfront payment of $28 million in consideration for the exclusive worldwide rights to SAN711, along with potential milestone payments of up to $582 million. The potential milestone payments figure comprises up to $147 million tied to the development and commercialization of SAN711 for its first and second indications and up to $435 million based on global annual net sales thresholds.
Additionally, Acadia is liable to make tiered royalty payments of mid-single digits to low double digits on net sales of commercial products that may result from the development of SAN711.
ACAD will oversee further clinical development, regulatory submissions and worldwide commercialization of SAN711 while funding Saniona’s ongoing early-stage study of the candidate and phase II study preparations.
ACAD’s Marketed Portfolio of Drugs
Acadia’s commercial portfolio currently comprises two marketed drugs — Nuplazid (pimavanserin) and the newly launched Daybue (trofinetide).
Acadia’s first drug, Nuplazid, is the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. Its second product, Daybue, received approval last year for treating 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 nine months ended Sept. 30, 2024, Nuplazid sales generated $446.5 million in revenues, up 10% year over year, driven by volume growth. Daybue sales, on the other hand, help generate incremental revenues for the company.
ACAD’s Key Pipeline Programs
Besides the performance of its marketed portfolio of drugs, Acadia’s efforts to expand its portfolio beyond Nuplazid are commendable.
Acadia is evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS) in the phase III COMPASS study. Subject to the success of the 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 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.
Over the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 21.5% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
Over the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.92. PFE shares have lost 10.6% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
Over the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024 while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 12.8% year to date.
Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.
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ACAD Signs License Deal With Saniona for Rights to Neurology Drug
Acadia Pharmaceuticals (ACAD - Free Report) announced that it has signed an exclusive worldwide license agreement with Saniona, a Denmark-based clinical-stage biopharmaceutical company, to develop and commercialize SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator.
As its first indication, Acadia plans to study SAN711 for essential tremor, a neurological condition that includes shaking or trembling movements in one or more parts of the body. The company is gearing up to initiate a mid-stage study of the candidate for the essential tremor indication in 2026.
This strategic move aligns with ACAD’s longstanding commitment to delivering innovative therapies for patients with central nervous system disorders. Per the company, essential tremor has lacked innovative treatment options for decades, highlighting a significant unmet need. Leveraging Acadia’s extensive expertise in developing and commercializing advanced therapies for neurological disorders, the company aims to address this gap through its work with SAN711.
Year to date, shares of Acadia have plunged 48.2% compared with the industry’s 7.8% decline.
Image Source: Zacks Investment Research
Per the terms of the licensing agreement, ACAD is liable to pay Saniona an upfront payment of $28 million in consideration for the exclusive worldwide rights to SAN711, along with potential milestone payments of up to $582 million. The potential milestone payments figure comprises up to $147 million tied to the development and commercialization of SAN711 for its first and second indications and up to $435 million based on global annual net sales thresholds.
Additionally, Acadia is liable to make tiered royalty payments of mid-single digits to low double digits on net sales of commercial products that may result from the development of SAN711.
ACAD will oversee further clinical development, regulatory submissions and worldwide commercialization of SAN711 while funding Saniona’s ongoing early-stage study of the candidate and phase II study preparations.
ACAD’s Marketed Portfolio of Drugs
Acadia’s commercial portfolio currently comprises two marketed drugs — Nuplazid (pimavanserin) and the newly launched Daybue (trofinetide).
Acadia’s first drug, Nuplazid, is the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. Its second product, Daybue, received approval last year for treating 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 nine months ended Sept. 30, 2024, Nuplazid sales generated $446.5 million in revenues, up 10% year over year, driven by volume growth. Daybue sales, on the other hand, help generate incremental revenues for the company.
ACAD’s Key Pipeline Programs
Besides the performance of its marketed portfolio of drugs, Acadia’s efforts to expand its portfolio beyond Nuplazid are commendable.
Acadia is evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS) in the phase III COMPASS study. Subject to the success of the 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 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.
ACADIA Pharmaceuticals Inc. Price and Consensus
ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote
Zacks Rank and Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold).
Some better-ranked pharma stocks are Allogene Therapeutics (ALLO - Free Report) , Pfizer (PFE - Free Report) and Gilead Sciences (GILD - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 21.5% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
Over the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.92. PFE shares have lost 10.6% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
Over the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024 while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 12.8% year to date.
Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.