Welcome to our dedicated page for Acadia Pharmaceuticals news (Ticker: ACAD), a resource for investors and traders seeking the latest updates and insights on Acadia Pharmaceuticals stock.
Acadia Pharmaceuticals (NASDAQ: ACAD) generates news flow typical of a commercial-stage biopharmaceutical company focused on central nervous system disorders. As a CNS-focused biotech, Acadia's announcements span FDA regulatory decisions, clinical trial results, quarterly earnings reports, and pipeline development updates.
Clinical trial readouts represent significant news events for Acadia, as Phase 2 and Phase 3 study results determine whether drug candidates advance toward potential approval. COMPASS and LOTUS studies exemplify the types of clinical programs that generate data presentations at medical conferences and subsequent news coverage analyzing implications for the company's pipeline.
FDA interactions produce material announcements including new drug application submissions, complete response letters, and approval decisions. For a company concentrated in CNS therapeutics, regulatory milestones carry particular weight given the complexity of developing treatments for neurological and psychiatric conditions.
Quarterly earnings reports reveal commercial product performance, pipeline investment levels, and cash position updates. As Acadia balances commercial revenue against research and development spending, earnings calls provide insight into the sustainability of this business model and management's capital allocation priorities.
Executive appointments and governance changes reflect Acadia's organizational development as it expands commercial and clinical capabilities. R&D Day events and investor presentations offer deeper visibility into scientific strategy and long-term pipeline direction.
Bookmark this page to follow Acadia's clinical development progress, regulatory interactions, and commercial performance in the CNS therapeutics space.
Acadia Pharmaceuticals (NASDAQ: ACAD) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for trofinetide to treat Rett syndrome in patients two years and older. If approved, it would be the first therapy for Rett syndrome in the EU. The drug is already approved in the US and Canada.
The application is supported by positive results from the Phase 3 LAVENDER study of 187 participants. The study met its co-primary endpoints, showing statistically significant improvements in both the Rett Syndrome Behaviour Questionnaire (RSBQ) total score and Clinical Global Impression-Improvement (CGI-I) scale score at week 12. The key secondary endpoint measuring communication and social behavior was also met.
Rett syndrome affects approximately 1 in 10,000-15,000 female births worldwide. It's a rare neurodevelopmental disorder typically caused by a MECP2 gene mutation, characterized by normal early development followed by regression in communication skills and purposeful hand use.
Acadia Pharmaceuticals (ACAD) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. CEO Catherine Owen Adams will present on January 14, 2025, at 9:00 a.m. PT / 12:00 p.m. ET. The presentation will be available via live webcast on Acadia.com's investor section, with a recording accessible for approximately one month afterward.
Acadia is a neuroscience company that has developed pioneering treatments, including the first FDA-approved drug for Parkinson's disease psychosis-related hallucinations and delusions, and the first approved treatment for Rett syndrome in the US and Canada. The company's clinical-stage pipeline focuses on Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Acadia Pharmaceuticals (NASDAQ: ACAD) has granted inducement awards to thirteen new employees on December 4, 2024. The awards include non-qualified stock options to purchase 38,568 shares at $17.17 per share and 22,264 restricted stock units (RSUs). The stock options will vest over four years, with 25% vesting after one year and the remainder monthly over 36 months. The RSUs will vest over four years, with 50% vesting at the second anniversary and the remaining in two annual installments.
The awards were approved by the Compensation Committee under Acadia's 2024 Inducement Plan, complying with Nasdaq Listing Rule 5635(c)(4). The company focuses on neuroscience breakthroughs and has developed FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome.
Acadia Pharmaceuticals (ACAD) has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million before fees and expenses. Per a previous agreement announced on November 5, 2024, Neuren Pharmaceuticals will receive one-third of the net proceeds. The company plans to utilize the funds to support its commercial operations, R&D programs in central nervous system and rare disease, and future business development.
Acadia specializes in neuroscience breakthroughs and has developed FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. Their clinical-stage pipeline includes programs for Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Acadia Pharmaceuticals (NASDAQ: ACAD) has appointed Thomas Andrew Garner as Chief Commercial Officer, effective immediately. Garner brings over 25 years of pharmaceutical industry experience and will lead Acadia's commercial strategy and operations, focusing on growth and portfolio expansion across U.S. and international markets.
Garner joins from Lexicon Pharmaceuticals, where he served as SVP and CCO. Previously, he spent 21 years at Bristol Myers Squibb in various senior roles, including leading their U.S. Cardiovascular unit with revenues exceeding $10 billion. The company also announced Holly Valdiviez's promotion to SVP, Neuropsychiatric Franchise, overseeing NUPLAZID sales and marketing.
Acadia Pharmaceuticals (NASDAQ: ACAD) has secured an exclusive worldwide license agreement with Saniona for SAN711, a first-in-class GABAA-α3 positive allosteric modulator. The company plans to develop SAN711 for essential tremor treatment, with Phase 2 studies expected to begin in 2026. Under the agreement, Saniona will receive a $28 million upfront payment plus potential milestone payments up to $582 million and tiered royalties ranging from mid-single digits to low double digits on net sales. The milestone payments include up to $147 million for development achievements and up to $435 million tied to annual sales thresholds.
Acadia Pharmaceuticals (Nasdaq: ACAD) has announced its participation in two major investor conferences in December 2024. The company will present at Citi's 2024 Global Healthcare Conference in Miami on December 3 at 10:15 a.m. ET, and the 7th Annual Evercore HealthCONx Conference in Coral Gables on December 4 at 2:35 p.m. ET. Both fireside chats will be available via webcast on Acadia.com.
Acadia specializes in neuroscience breakthroughs and has developed FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. Their current clinical-stage research focuses on Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Acadia Pharmaceuticals (Nasdaq: ACAD) announced that its Compensation Committee granted inducement awards to 23 new employees on November 8, 2024. The awards include 70,571 non-qualified stock options at $17.66 per share and 40,731 restricted stock units (RSUs). The stock options will vest over four years, with 25% vesting after one year and the remainder monthly over 36 months. The RSUs will vest over four years, with 50% vesting after two years and the remaining in two annual installments, all subject to continued employment.
Acadia Pharmaceuticals announced its third quarter 2024 financial results, reporting total revenues of $250.4 million, an 18% increase year-over-year. NUPLAZID net product sales were $159.2 million, up 10% year-over-year, while DAYBUE net product sales reached $91.2 million, a 36% increase. CEO Catherine Owen Adams highlighted the company's path to achieving over $1 billion in annualized sales by 2025. Research and development expenses decreased to $66.6 million, primarily due to reduced business development payments. Selling, general, and administrative expenses rose to $133.3 million, driven by marketing costs. The company reported a net income of $32.8 million, or $0.20 per share, compared to a net loss of $65.2 million in the same period last year. Acadia's cash and investments totaled $565.3 million. The company updated its 2024 guidance, expecting total revenues between $940 to $960 million, NUPLAZID sales of $600 to $610 million, and DAYBUE sales of $340 to $350 million.
Acadia Pharmaceuticals (Nasdaq: ACAD) has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million. The PRV was granted in March 2023 following FDA approval of DAYBUE™ for Rett syndrome treatment. Under a previous license agreement with Neuren Pharmaceuticals, Acadia must pay one-third of the net proceeds to Neuren. The company plans to use the proceeds to support commercial operations, R&D programs in central nervous system and rare disease, and future business development. The transaction is subject to customary closing conditions, including HSR Antitrust Act requirements.
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