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ACADIA Pharmaceuticals Inc

ACADIA Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing medicines for neurological and rare diseases in North America. Its products include NUPLAZID (pimavanserin), a selective serotonin inverse agonist/antagonist for hallucinations and delusions associated with Parkinson's disease psychosis, and DAYBUE, a synthetic analog of the amino-terminal tripeptide of insulin-like growth factor 1 for Rett syndrome symptoms. The company also develops remlifanserin in Phase 2 for Alzheimer's disease psychosis and Lewy body dementia psychosis, ACP-211 in Phase 2 for major depressive disorder, ACP-711 in Phase 1 for essential tremor, and ACP-271, a GPR88 agonist in Phase 1 for tardive dyskinesia and Huntington's disease. Additionally, it develops ACP-2591, a cGP analogue in Phase 1 for Rett syndrome and fragile X syndrome, and the STOKE Antisense Oligonucleotide Program in discovery for SYNGAP1 syndrome. It has a license agreement with Neuren Pharmaceuticals Limited for trofinetide and a license and collaboration agreement with Stoke Therapeutics, Inc. for RNA-based medicines for severe and rare genetic neurodevelopmental diseases of the CNS. Formerly known as Receptor Technologies, Inc., it changed its name to ACADIA Pharmaceuticals Inc. in 1997, was incorporated in 1993, and is headquartered in San Diego, California.

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United States
Biotech & Genomic Medicine▼

ACADIA Pharmaceuticals Falls 13% After Remlifanserin Phase 2 Miss, Goldman Reiterates Sell

ACADIA Pharmaceuticals shares fell 12.78 percent to close at $22.18 on Thursday, a fifth straight daily decline, after Goldman Sachs reiterated its sell rating and $17 price target on the stock following a Phase 2 trial miss. The trial of remlifanserin, a 5-HT2A inverse agonist, failed its primary endpoint in treating hallucinations and delusions in patients with Alzheimer's disease psychosis, and the $17 target implies a 23 percent discount to the latest close. The study will still advance to Phase 3, but ACADIA plans to drop the 30 mg dosage arm because of a lack of efficacy improvement in the completed trial, and detailed safety and efficacy data are set for an oral presentation at the Clinical Trials on Alzheimer's Disease conference in Boston on November 16 to 19, 2026. Citigroup kept its buy rating while cutting its price target to $33 from $40, and BMO Capital maintained an outperform rating while lowering its target to $34 and trimming its probability-of-success estimate for the drug to 35 percent from 40 percent. Insider Monkey data show 38 hedge funds held the stock in the second quarter, down from 39, but their combined holdings rose 13.67 percent to $1.58 billion from $1.39 billion quarter over quarter.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative Technology
ACAD · Technology · Negative Remlifanserin failed its Phase 2 primary endpoint in Alzheimer's disease psychosis and the 30 mg arm is being dropped for lack of efficacy.
ACAD · Capital · Negative Goldman Sachs reiterated its sell rating and $17 price target, while Citigroup and BMO cut their targets after the trial miss.
C · Capital · Neutral Citigroup kept its buy rating but cut its ACADIA price target to $33 from $40; no impact on Citigroup itself.
GS · Capital · Neutral Goldman Sachs reiterated its sell rating and $17 price target on ACADIA; no impact on Goldman itself.
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Biotech & Genomic Medicine▲

Acadia Gets European Commission Nod for Daybu in Rett Syndrome

Acadia Pharmaceuticals announced that the European Commission has granted marketing authorization for Daybu, also known as trofinetide, to treat neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. The approval makes Daybu the first and only treatment approved for this indication in the European Union, covering all 27 EU member states plus Iceland, Liechtenstein and Norway. Acadia will now begin pricing and reimbursement negotiations with national authorities to bring the therapy to patients across the EU. The decision follows a positive opinion from the European Medicines Agency's advisory committee in June 2026 and is supported by data from the pivotal phase III LAVENDER study, which met its co-primary endpoints. In the United States, the drug is marketed as Daybue and was approved by the FDA in 2023 for patients aged two years and older; it is also available in Canada and Israel. Acadia raised its 2026 Daybue sales projection to $480-$510 million from the previous range of $460-$490 million, while maintaining Nuplazid sales guidance of $760-$790 million.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▲Regulation
ACAD · Regulation · Positive European Commission approval for Daybu in Rett syndrome, first in EU, expands market and raises sales guidance.
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United States
Biotech & Genomic Medicine▲2

Acadia Pharmaceuticals Raises 2026 DAYBUE Sales Guidance to $480-$510 Million

Acadia Pharmaceuticals raised its full-year 2026 net sales guidance for DAYBUE to $480 million to $510 million, up from the prior range of $460 million to $490 million, driven by strong second-quarter performance and rapid uptake of the new DAYBUE STIX powder formulation. Total second-quarter revenues reached $308 million, a 17% adjusted year-over-year increase, with DAYBUE net sales of $125 million growing 30% and NUPLAZID net sales of $183 million up 10% on an adjusted basis. The company reaffirmed its 2026 NUPLAZID sales guidance of $760 million to $790 million and updated its total revenue outlook to $1.24 billion to $1.30 billion, while lowering R&D expense guidance to $355 million to $380 million due to a business development milestone shifting to 2027. Management also highlighted the upcoming Phase II readout for remlifanserin in Alzheimer's disease psychosis, expected in September to October 2026, with peak sales potential estimated at $4 billion across Alzheimer's disease psychosis and Lewy body dementia psychosis.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▲Demand
ACAD · Demand · Positive Raises 2026 DAYBUE sales guidance on strong Q2 performance and rapid uptake of new STIX formulation.
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United States
ACAD▲

Acadia Pharmaceuticals Fair Value Raised to $33.25 as Analysts Back Daybue Growth

Acadia Pharmaceuticals' fair value estimate has been raised from $31.80 to $33.25 per share, reflecting updated assumptions around its business outlook. Revenue growth assumption adjusts from 13.61% to 13.54%, net profit margin assumption shifts from 18.26% to 19.03%, future P/E multiple changes from 24.51 times to 23.28 times, and discount rate moves from 7.10% to 7.25%. Several analysts have raised price targets, with BofA, Deutsche Bank, Canaccord, Citi, Citizens and BMO now clustered in the mid $30s range, citing Daybue's second-quarter revenue of $308 million versus a $296 million consensus and updated fiscal 2026 Daybue guidance of $480 million to $510 million. The positive CHMP opinion for trofinetide in Europe is seen as important for the Daybue story, while upcoming Phase 2 remlifanserin data is viewed as a major potential catalyst, with Citi placing the stock on an upside 90-day catalyst watch tied to the Alzheimer's disease psychosis readout. Stifel maintains a Hold rating with a $25 target, describing remlifanserin as high risk and high reward, and Oppenheimer keeps a Perform rating despite stronger Daybue trends.
ACAD · Capital · Positive Analysts raise price targets and fair value estimate on Daybue revenue beat and guidance.
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Global
Biotech & Genomic Medicine▲

Alzheimer's Disease Market Projected to Reach USD 4 Billion in 2025 with 22.7% CAGR Through 2036

The Alzheimer's disease market across the seven major markets was valued at approximately USD 4 billion in 2025 and is projected to expand at a CAGR of 22.7% through 2036, according to DelveInsight. The growth is driven by increasing disease prevalence, broader adoption of disease-modifying therapies, advancements in biomarker-based diagnosis, and a robust late-stage pipeline. Key emerging therapies include Masupirdine from Suven Life Sciences, Roche's Trontinemab, Annovis Bio's Buntanetap, AB Science's Masitinib, Eli Lilly's Remternetug, Axsome Therapeutics' AUVELITY, Biovie's Bezisterim, ALZHEON's Valiltramiprosate, TauRx Therapeutics' Hydromethylthionine mesylate, Bristol Myers Squibb's COBENFY, AriBio's AR1001, Acadia Pharmaceuticals' Remlifanserin, and Cerecin's Tricaprilin. The report highlights six late-stage candidates poised to enter the market, including Masupirdine, Trontinemab, AXS-05, COBENFY, Remternetug, and Buntanetap, each with distinct mechanisms of action and anticipated clinical milestones.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▲Demand
LLY · Demand · Positive Eli Lilly's Remternetug is listed as a key emerging therapy in a growing Alzheimer's market.
ROP.SW · Demand · Positive Roche's Trontinemab is highlighted as a late-stage candidate in an expanding market.
AB.PA · Demand · Positive AB Science's Masitinib is mentioned as a key emerging therapy in the Alzheimer's market.
Alzheon, Inc. · Demand · Positive Alzheon's Valiltramiprosate is listed among key emerging therapies in the growing market.
Suven Life Sciences Ltd · Demand · Positive Suven Life Sciences' Masupirdine is a late-stage candidate in the expanding Alzheimer's market.
ANVS · Technology · Positive Buntanetap is highlighted as a late-stage candidate with anticipated clinical milestones.
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Biotech & Genomic Medicine▲

Dementia-related psychosis market projected to grow at 26.2% CAGR through 2036

The dementia-related psychosis market across the seven major markets is forecast to expand at a compound annual growth rate of 26.2% from 2026 to 2036, according to a new report from DelveInsight. The market was valued at 690 million US dollars in 2025, with the United States accounting for approximately 77% of that total. More than 5 million diagnosed prevalent cases were reported across the seven major markets in 2025, including over 2 million in the US, where Alzheimer's disease dementia represented the largest share. Key therapies in development include ACP-204 from Acadia Pharmaceuticals, COBENFY from Bristol Myers Squibb, Zervimesine from Cognition Therapeutics, ML-007C-MA from Maplight Therapeutics, ITI-1284 from Johnson & Johnson, and low-dose levetiracetam from AgeneBio.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative ▲Demand
ACAD · Demand · Positive ACP-204 is a key therapy in development for dementia-related psychosis, a market projected to grow at 26.2% CAGR.
CGTX · Demand · Positive Zervimesine is a key therapy in development for dementia-related psychosis, a market with strong projected growth.
MPLT · Demand · Positive ML-007C-MA is a key therapy in development for dementia-related psychosis, a market with high growth forecast.
BMY · Demand · Positive COBENFY is listed as a key therapy in development for the growing dementia-related psychosis market.
JNJ · Demand · Positive ITI-1284 is a key therapy in development for dementia-related psychosis, a market projected to grow significantly.
AgeneBio · Demand · Positive Low-dose levetiracetam is listed as a key therapy in the growing dementia-related psychosis market.
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ACAD▲2

Zacks Highlights Five Biotech Stocks Poised for Q2 Earnings Beats

Zacks Equity Research has identified five biotech companies that are expected to beat earnings estimates in their upcoming second-quarter 2026 reports. The stocks are Harmony Biosciences, Acadia Pharmaceuticals, Biogen, Insmed, and Agios Pharmaceuticals, each combining a positive Earnings ESP with a Zacks Rank of 1, 2, or 3. Harmony Biosciences carries an Earnings ESP of +14.14% and a Zacks Rank #1, with a consensus estimate of 97 cents per share, and reports on August 4 before the open. Acadia Pharmaceuticals has an Earnings ESP of +25.00% and a Zacks Rank #2, with a consensus of 6 cents per share, reporting after the close on August 4. Biogen shows an Earnings ESP of +220.79% and a Zacks Rank #3, with a consensus of 94 cents per share, and reports on July 29 before the open. Insmed has an Earnings ESP of +22.32% and a Zacks Rank #3, with a consensus loss of 69 cents per share, reporting on August 6 before the open. Agios Pharmaceuticals has an Earnings ESP of +12.67% and a Zacks Rank #3, with a consensus loss of $1.86 per share, and reports on July 30 before the open.
ACAD · Capital · Positive Zacks identifies Acadia as likely to beat Q2 earnings estimates with a positive Earnings ESP and Zacks Rank #2.
AGIO · Capital · Positive Zacks identifies Agios as likely to beat Q2 earnings estimates with a positive Earnings ESP and Zacks Rank #3.
BIIB · Capital · Positive Zacks identifies Biogen as likely to beat Q2 earnings estimates with a positive Earnings ESP and Zacks Rank #3.
HRMY · Capital · Positive Zacks identifies Harmony Biosciences as likely to beat Q2 earnings estimates with a positive Earnings ESP and Zacks Rank #1.
INSM · Capital · Positive Zacks identifies Insmed as likely to beat Q2 earnings estimates with a positive Earnings ESP and Zacks Rank #3.
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Zacks Research Flags Four Medical Stocks Poised for Q2 Earnings Beats

Zacks Investment Research has identified four medical-sector companies with the right setup to beat second-quarter earnings expectations. The picks are CVS Health, Cardinal Health, Humana, and ACADIA Pharmaceuticals, each combining a positive Earnings ESP with a Zacks Rank of 1 or 2. Humana carries a Zacks Rank of 1 and an Earnings ESP of plus 1.71 percent, with consensus revenue estimates of 40.65 billion dollars implying 25.5 percent growth. CVS Health holds a Zacks Rank of 2 and an Earnings ESP of plus 1.42 percent, with consensus revenue of 100.18 billion dollars. Cardinal Health also has a Zacks Rank of 2 and an Earnings ESP of plus 1.24 percent, with fiscal fourth-quarter revenue pegged at 65.61 billion dollars. ACADIA Pharmaceuticals rounds out the list with a Zacks Rank of 2 and an Earnings ESP of plus 25.00 percent, driven by expected growth from Daybue and Nuplazid.
ACAD · Capital · Positive Zacks identifies ACADIA as having a positive Earnings ESP of 25% and strong Rank, indicating likely earnings beat.
CAH · Capital · Positive Zacks identifies Cardinal Health as having a positive Earnings ESP and strong Rank, indicating likely earnings beat.
CVS · Capital · Positive Zacks identifies CVS Health as having a positive Earnings ESP and strong Rank, indicating likely earnings beat.
HUM · Capital · Positive Zacks identifies Humana as having a positive Earnings ESP and strong Rank, indicating likely earnings beat.
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Biotech & Genomic Medicine▲

FDA Grants Fast Track Designation to Acadia Pharma's Remlifanserin for Alzheimer's Psychosis

The U.S. Food and Drug Administration has granted Fast Track designation to Acadia Pharmaceuticals' remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis. Acadia also announced that enrollment in the Phase 2 portion of its RADIANT program evaluating remlifanserin for ADP has been completed, with topline results expected between September and October 2026. Acadia shares rose nearly 2% in pre-market trading after closing at $25.60 on Friday.
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Biotech & Genomic Medicine › Neuroscience & Neurodegenerative Regulation
ACAD · Regulation · Positive FDA Fast Track designation accelerates development and review for remlifanserin in Alzheimer's psychosis.
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Acadia Pharmaceuticals Insider Sold 46.6% of Direct Holdings

Acadia Pharmaceuticals Principal Accounting Officer James Kihara sold 11,421 shares on June 26, 2026, representing 46.60% of his direct holdings. The transaction was valued at approximately $298,000 and reduced his direct ownership to 13,088 shares. The sale was executed under a pre-established Rule 10b5-1 trading plan adopted in December 2025. It occurred as Acadia shares neared a 52-week high following a positive European regulatory recommendation for its Daybue drug. The company reported first-quarter 2026 revenue of $268.1 million, up from $244.3 million a year earlier.
ACAD · Capital · Neutral Insider sold 46.6% of direct holdings under a 10b5-1 plan, but shares neared 52-week high on positive EU regulatory recommendation for Daybue and revenue growth.
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ACAD

Acadia Pharmaceuticals Appoints Carl Segerstrom as Chief People Officer

Acadia Pharmaceuticals has appointed Carl Segerstrom as Chief People Officer, effective July 6. Segerstrom will lead the company's global people and culture strategy and serve on the executive leadership team. He brings more than 25 years of global human resources leadership experience, most recently as Senior Vice President of Human Resources at Merck's Human Health Division, supporting a $50+ billion business across 80 countries. His background includes roles as Chief Talent Officer at Merck and HR leadership positions at Pharmacia, Schering-Plough, and Pfizer. Acadia is focused on advancing therapies for neurological and rare diseases, with a commercial portfolio that includes the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome.
ACAD · · Neutral Appointment of a new Chief People Officer is a routine corporate change; no clear impact on business performance.
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CHMP recommends DAYBU for Rett syndrome neurobehavioral symptoms in EU

The European Medicines Agency's CHMP has recommended marketing authorization for DAYBU (trofinetide) to treat neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five and older. If approved by the European Commission, DAYBU would become the first therapy for this indication in the European Union. The positive opinion follows a re-examination procedure and is based on Phase 3 LAVENDER study results showing significant improvements on the Rett Syndrome Behaviour Questionnaire and Clinical Global Impression-Improvement scale. A final decision from the European Commission is expected in the coming months, and approval would apply to all 27 EU member states plus Iceland, Liechtenstein, and Norway.
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Biotech & Genomic Medicine › Rare Disease ▲Regulation
ACAD · Regulation · Positive CHMP positive opinion for DAYBU (trofinetide) in EU, first therapy for Rett syndrome neurobehavioral symptoms.
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