Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Corporate Update (April 2021)
13 slides from Acadia Pharmaceuticals's corporate update, Apr 5, 2021
Slide 1: Regulatory Update on DRP sNDA
Exhibit 99.2 Regulatory Update on DRP sNDA April 5, 2021Exhibit 99.2 Regulatory Update on DRP sNDA April 5, 2021
Slide 2: Agenda
Agenda Introduction Mark Johnson | Vice President, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Discussion Serge Stankovic, M.D., M.S.P.H | President CEO Closing Remarks Steve Davis | Chief Executive Officer Steve Davis | Chief Executive Officer Q&A Serge Stankovic, M
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future r
Slide 4: Opening Remarks
Opening Remarks Steve Davis Chief Executive Officer Opening Remarks Steve Davis Chief Executive Officer
Slide 5: Opening Remarks: Prior Agreements with the Division of Psychiatry
Opening Remarks Prior Agreements between Acadia and the Division of Psychiatry: • Agreement on pivotal HARMONY Phase 3 study design • Agreement on primary endpoint of HARMONY as risk of relapse of psychosis of pimavanserin compared to placebo in the broad DRP patient population to be analyzed as a s
Slide 6: Pivotal HARMONY Study for DRP
Pivotal HARMONY Study for DRP Highly statistically significant results in pivotal Phase 3 HARMONY study 1 Clinically meaningful results in pivotal Phase 3 HARMONY study 2 Delivered persuasive results from the agreed upon pivotal study design 3 targeting a broad DRP patient population analyzed as a s
Slide 7: Discussion
Discussion Serge Stankovic PresidentDiscussion Serge Stankovic President
Slide 8: Pivotal HARMONY Study Results
Pivotal HARMONY Study Results “If you wish to rely on a single well-controlled study for your sNDA filing, the findings must be very persuasive. This means statistically significant with a very small probability of Type I error and a finding that is clinically meaningful.” – FDA, End-of-Phase 2 Meet
Slide 9: Agreement on Pivotal Study Design
Agreement on Pivotal Study Design Agreed with the Division Pivotal Study Results CRL Response “…the Division agreed that the “The sNDA submission does not Highly statistically significant and randomized withdrawal trial as provide substantial evidence of clinically meaningful study results described
Slide 10: Agreement on Target Patient Population
Agreement on Target Patient Population Agreed with the Division Pivotal Study Results CRL Response “We agree that treatment of “Findings from Study -045 Highly statistically significant and hallucinations and delusions in suggest a differential response to clinically meaningful study results dementi
Slide 11: Closing Remarks
Closing Remarks Steve Davis Chief Executive Officer Closing Remarks Steve Davis Chief Executive Officer
Slide 12: Conclusion and Next Steps
Conclusion and Next Steps 1. Agreed with the Division of Psychiatry that a single, positive, randomized withdrawal study with very persuasive efficacy would be sufficient for approval in DRP 2. Delivered the highly statistically significant and clinically meaningful results from the agreed upon pivo
Slide 13: Q&A Session
Q&A SessionQ&A Session
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