ACADIA Pharma (ACAD) Trades Strong as Pimavanserin Met Primary Endpoint in Phase III
Get Alerts ACAD Hot Sheet
Join SI Premium – FREE
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) is popping higher Thursday following positive data tied to its pimavanserin phase III. The company said that pimavanserin met its primary endpoint in -020 Study with pimavanserin.
Shares are up about 25 percent with heavy volume.
The release is below:
ACADIA Pharmaceuticals Inc. announced that Jeffrey Cummings, M.D., Sc.D., Director of Cleveland Clinic Lou Ruvo Center for Brain Health, presented detailed results today from ACADIA’s pivotal Phase III -020 Study with pimavanserin in patients with Parkinson’s disease psychosis at the Emerging Science session of the 65th American Academy of Neurology (AAN) Annual Meeting. The analysis of the full data set from the Phase III -020 Study showed robust and consistent efficacy of pimavanserin across a wide array of study measures and confirmed the positive top-line results previously reported.
Pimavanserin met the primary endpoint in the -020 Study by demonstrating highly significant antipsychotic efficacy on the 9-item SAPS-PD scale (p=0.001). Pimavanserin also met the key secondary endpoint for motoric tolerability as measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale, or UPDRS. Dr. Cummings presented new data from the -020 Study showing highly significant improvements in all secondary efficacy measures, including the Clinical Global Impression Severity, or CGI-S, scale (p<0.001), the Clinical Global Impression Improvement, or CGI-I, scale (p=0.001), and a CGI-I responder analyses (p=0.002). The CGI-I responder results showed that approximately twice as many subjects in the pimavanserin treatment arm, as compared to placebo, were rated as very much improved or much improved at the conclusion of the study. In addition, pimavanserin demonstrated significant improvements using the full 20-item SAPS scale and each of the separate hallucinations and delusions domains in supportive analyses. Statistically significant benefits were also observed in exploratory measures of nighttime sleep, daytime wakefulness, and caregiver burden.
Shares are up about 25 percent with heavy volume.
The release is below:
ACADIA Pharmaceuticals Inc. announced that Jeffrey Cummings, M.D., Sc.D., Director of Cleveland Clinic Lou Ruvo Center for Brain Health, presented detailed results today from ACADIA’s pivotal Phase III -020 Study with pimavanserin in patients with Parkinson’s disease psychosis at the Emerging Science session of the 65th American Academy of Neurology (AAN) Annual Meeting. The analysis of the full data set from the Phase III -020 Study showed robust and consistent efficacy of pimavanserin across a wide array of study measures and confirmed the positive top-line results previously reported.
Pimavanserin met the primary endpoint in the -020 Study by demonstrating highly significant antipsychotic efficacy on the 9-item SAPS-PD scale (p=0.001). Pimavanserin also met the key secondary endpoint for motoric tolerability as measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale, or UPDRS. Dr. Cummings presented new data from the -020 Study showing highly significant improvements in all secondary efficacy measures, including the Clinical Global Impression Severity, or CGI-S, scale (p<0.001), the Clinical Global Impression Improvement, or CGI-I, scale (p=0.001), and a CGI-I responder analyses (p=0.002). The CGI-I responder results showed that approximately twice as many subjects in the pimavanserin treatment arm, as compared to placebo, were rated as very much improved or much improved at the conclusion of the study. In addition, pimavanserin demonstrated significant improvements using the full 20-item SAPS scale and each of the separate hallucinations and delusions domains in supportive analyses. Statistically significant benefits were also observed in exploratory measures of nighttime sleep, daytime wakefulness, and caregiver burden.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- PTC Therapeutics (PTCT) Provides Regulatory Updates
- Nexa Resources (NEXA) Provides Update on Morro Agudo Complex
- Keurig Dr Pepper Inc. (KDP) to Outline Strategy and Value-creation Opportunities
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!