ACADIA Pharmaceuticals Inc

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.

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.

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.

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.

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.

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.

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.

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.

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.