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Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) is a biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders. Established with a commitment to scientific excellence and leadership in CNS research, Acadia's proprietary drug discovery platform has enabled the creation of a robust portfolio targeting conditions such as Parkinson's disease psychosis, Alzheimer's disease psychosis, Rett syndrome, and schizophrenia.
Acadia's pivotal achievements include the development and commercialization of NUPLAZID, the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis, and DAYBUE, the first and only FDA-approved drug for the treatment of Rett syndrome. The company's clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Situated in San Diego, one of the largest biotechnology hubs in the United States, Acadia benefits from proximity to over 400 companies and renowned research institutions like the Salk Institute for Biological Studies. This strategic location supports Acadia's mission to bring groundbreaking therapies to patients in need.
Financially, Acadia has shown significant growth, with total revenues reaching $205.8 million for the first quarter of 2024, reflecting a 74% year-over-year increase, largely due to the strong market performance of NUPLAZID and the addition of DAYBUE. The company continues to invest in its pipeline and commercial operations, maintaining a solid cash position with $470.5 million in cash, cash equivalents, and investment securities as of March 31, 2024.
Recent highlights include participation in major healthcare conferences, strategic appointments to enhance leadership in research and development, and ongoing efforts to expand the reach of DAYBUE beyond the U.S. market. Acadia’s unwavering dedication to advancing neuroscience and improving patient outcomes underscores its long-term growth potential and commitment to innovation in the biopharmaceutical landscape.
Acadia Pharmaceuticals announced that Health Canada has approved DAYBUE™ (trofinetide) for the treatment of Rett syndrome in patients two years and older. This marks the first and only therapy approved in Canada for this rare neurodevelopmental disorder, which affects an estimated 600 to 900 patients in the country.
The approval was based on positive results from the Phase 3 LAVENDER™ study, which showed statistically significant improvements in the co-primary endpoints: the Rett Syndrome Behaviour Questionnaire (RSBQ) total score and the Clinical Global Impression-Improvement (CGI-I) scale score at week 12.
Rett syndrome primarily affects females and is characterized by regression following normal development in the first two years of life. Symptoms include loss of communication skills, purposeful hand use, and gait abnormalities. The approval of DAYBUE represents a significant milestone for patients and their families, offering a specific therapy for a condition that previously only had symptomatic management options.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has announced inducement grants to thirteen new employees under its 2024 Inducement Plan. The Compensation Committee approved non-qualified stock options to purchase 111,631 shares of common stock and 30,484 restricted stock units (RSUs). The stock options have an exercise price of $14.72 per share, based on Acadia's closing price on October 3, 2024. Both stock options and RSUs will vest over four years, subject to continued employment. This grant aligns with Nasdaq Listing Rule 5635(c)(4).
Acadia Pharmaceuticals is known for developing the first FDA-approved drug for hallucinations and delusions in Parkinson's disease psychosis and for Rett syndrome treatment. The company is currently focusing on clinical-stage development for Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced on September 23, 2024, that its Board of Directors granted Catherine Owen Adams, the new Chief Executive Officer, a one-time sign-on equity award. The award consists of:
1. 353,261 options to purchase Acadia's common stock at $16.29 per share, vesting 25% on the first anniversary and monthly over the next three years.
2. 160,763 performance stock units, earnable based on relative total shareholder return metrics over three years (0-150% of target).
These Inducement Awards were approved under Acadia's 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4). Acadia is known for developing the first FDA-approved drugs for Parkinson's disease psychosis and Rett syndrome, with ongoing clinical-stage efforts in Prader-Willi syndrome and Alzheimer's disease psychosis.
Acadia Pharmaceuticals (Nasdaq: ACAD) has announced that Catherine Owen Adams has succeeded Steve Davis as Chief Executive Officer and joined the company's Board of Directors. Ms. Owen Adams brings over 25 years of pharmaceutical industry experience, including senior commercial leadership roles at Bristol Myers Squibb and Johnson & Johnson.
Ms. Owen Adams most recently served as Senior Vice President and General Manager, U.S., at Bristol Myers Squibb, where she led a $20 billion commercial business. Her extensive experience includes overseeing major product launches and leading large teams across multiple countries. The Board of Directors expressed confidence in her ability to guide Acadia through its next phase of growth, capitalizing on the company's strengths in treating central nervous system disorders and rare diseases.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has announced its participation in two upcoming investor conferences in New York, NY:
- Morgan Stanley 22nd Annual Global Healthcare Conference on September 4, 2024, at 4:50 p.m. Eastern Time
- Baird 2024 Global Healthcare Conference on September 11, 2024, at 9:40 a.m. Eastern Time
Both events will feature fireside chats, which will be livestreamed on Acadia's website and archived for approximately one month. Acadia, a neuroscience-focused company, has developed FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. Their ongoing clinical research targets Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Ryan Reynolds and Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) have launched the 'More to Parkinson's®' campaign to raise awareness about Parkinson's-related hallucinations and delusions. These non-motor symptoms affect around 50% of Parkinson's patients, but up to 90% don't report them to their doctors. Reynolds and his mother Tammy share their experiences caring for Ryan's late father, who had Parkinson's disease, to educate others about these under-recognized symptoms.
The campaign aims to encourage open discussions between patients, caregivers, and healthcare providers about managing these symptoms. It includes videos and resources on MoretoParkinsons.com, covering topics such as risk factors, symptom identification, and treatment options. The initiative seeks to address the significant gap in awareness and understanding of these non-motor symptoms, which can be more distressing than motor symptoms associated with Parkinson's disease.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has announced its participation in a fireside chat at the Canaccord Genuity 44th Annual Growth Conference on August 14, 2024 at 10:00 a.m. Eastern Time. The event will be webcast live on Acadia's website and archived for approximately one month.
Acadia is a neuroscience company with a 30-year history of developing breakthrough treatments. They have FDA-approved drugs for Parkinson's disease psychosis and Rett syndrome. Their current clinical-stage efforts focus on Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.
Acadia Pharmaceuticals (NASDAQ: ACAD) reported Q2 2024 financial results, highlighting a 46% YoY increase in total net product sales, reaching $242 million. Key contributors included a 11% YoY rise in NUPLAZID sales and an 11% sequential increase in DAYBUE sales. The company is progressing with Phase 3 trials for Prader-Willi syndrome and Phase 2/3 trials for Alzheimer’s disease psychosis.
Q2 net income was $33.4 million ($0.20 per share), a significant increase from $1.1 million the previous year. For the six months, net income was $49.9 million ($0.30 per share), reversing a loss of $41.9 million in H1 2023. R&D expenses rose to $76.2 million due to new projects. SG&A expenses were $117.1 million, primarily due to marketing initiatives.
Acadia updated its 2024 guidance, increasing NUPLAZID sales forecast to $590-$610 million but lowering DAYBUE sales projection to $340-$370 million. Total revenue guidance is now $930-$980 million.
Acadia Pharmaceuticals (Nasdaq: ACAD) announced it will report its second quarter financial results on August 6, 2024, post market close. The management team will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day to discuss the financial results and operations. The call will be accessible via Acadia's website under the investors section and archived until September 6, 2024. Participants can register online to receive a dial-in number and unique PIN for the call. Acadia Pharmaceuticals specializes in developing treatments for neuropsychiatric conditions and has FDA-approved drugs for Parkinson’s disease psychosis and Rett syndrome. The company is also conducting clinical-stage research on Prader-Willi syndrome and Alzheimer’s disease psychosis.
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has published results from two open-label extension studies, LILAC-1™ and LILAC-2™, evaluating the long-term safety and efficacy of DAYBUE™ (trofinetide) in patients with Rett syndrome. The studies showed continued improvements in RSBQ and CGI-I scores with long-term DAYBUE treatment. LILAC-1 was a 40-week extension of the 12-week Phase 3 LAVENDER™ trial, while LILAC-2 was a 32-month study. Both studies demonstrated a safety profile consistent with the LAVENDER trial, with diarrhea and vomiting as the most common side effects. These findings contribute to a growing body of research on DAYBUE's potential ongoing impact for Rett syndrome patients, with some patients being on treatment for over two years.
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