ACAD Stock Soars as US Court Rules in Favor of Key Nuplazid Patent

Acadia Pharmaceuticals ACAD shares surged 26.5% on Friday after the company announced that the U.S. District Court in Delaware had ruled in its favor concerning the ‘721 formulation patent for its lead drug, Nuplazid (pimavanserin). The Court upheld Acadia’s position on both infringement and validity in its patent litigation against Aurobindo Pharma Limited and other abbreviated new drug application filers.

Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States.

The judgment issued by the Delaware Court provides patent protection for the Nuplazid 34 mg capsule formulation until 2038. This is a huge win for Acadia. It protects the company’s Nuplazid sales from generic erosion in the U.S. market for the Parkinson’s disease indication while enabling it to focus on other strategic priorities. The drug generated $159.7 million in revenues in the first quarter of 2025, representing an increase of 23% year over year, driven primarily by volume growth.

Year to date, shares of Acadia have gained 21.3% against the industry’s decline of 6.9%.

The company also has another marketed drug in its commercial portfolio, Daybue (trofinetide), which is FDA-approved 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.

Daybue sales generate incremental revenues for ACAD. In the first quarter of 2025, the drug generated $84.6 million in revenues, up 11% year over year, driven by the growth in the drug’s unit sales as Acadia shipped to more unique patients. Per the company, ACAD reached a record high in first-quarter 2025, with 954 unique patients receiving a Daybue shipment.

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.

A regulatory filing for trofinetide to treat Rett syndrome in adults and pediatric patients aged two years and above is currently under review in the EU. An approval in the EU is expected in the first quarter of 2026.

ACAD is also witnessing favorable enrollment trends in the phase III COMPASS PWS study of ACP-101 for Prader-Willi Syndrome (PWS). As a result, the company now expects top-line results from the COMPASS PWS study early in the fourth quarter of 2025. Subject to positive results, Acadia plans to submit a regulatory application to the FDA, seeking the approval of ACP-101 for PWS in the first quarter of 2026.

Additionally, Acadia anticipates completing enrollment in the phase II RADIANT study of ACP-204 for Alzheimer’s disease psychosis in the first quarter of 2026. Top-line data is expected in mid-2026. Furthermore, the company is also gearing up to initiate a separate mid-stage study of ACP-204 for a second indication (Lewy Body dementia psychosis) in the third quarter of 2025.

Acadia and its partner, Saniona, have completed the two planned cohorts in the phase I multiple-ascending-dose study of ACP-711 in healthy volunteers. The drug demonstrated a strong safety and tolerability profile, with no serious adverse events reported and all participants completing the study. Most adverse events were mild, and no significant concerns related to safety labs, cardiovascular health, or neurological function were observed.

With these positive results, the companies are now focusing on essential tremor as the lead indication for ACP-711. They plan to seek regulatory approval to expand the study to elderly healthy volunteers and test higher repeated doses. Thus, the study has been temporarily paused until approval is granted for this next phase.

ACADIA Pharmaceuticals Inc. Price and Consensus

ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote

ACAD's Zacks Rank & Stocks to Consider

Acadia currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Bayer BAYRY, Halozyme Therapeutics HALO and Intellia Therapeutics NTLA, 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.

In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 30.5%. 

BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. 

In the past 60 days, estimates for Halozyme’s earnings per share have increased from $5.02 to $5.23 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.56 to $6.77. Year to date, shares of HALO have risen 8.8%.

HALO’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 17.60%.

In the past 60 days, estimates for Intellia Therapeutics’ loss per share have narrowed from $4.65 to $4.26 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.68 to $4.26. Year to date, shares of NTLA have plunged 27.1%.

NTLA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.17%.

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