Acadia Pharmaceuticals Inc. (ACAD) stock declined by 14.42% in the pre market trading session after Acadia Pharmaceuticals has received a response letter from FDA for its supplement new drug application (sNDA). Acadia is breaking new ground in neuroscience to improve people’s lives. ACAD has been at the forefront of healthcare for over 25 years, bringing critical ideas to those who need them most. We developed and marketed the first and only FDA-approved treatment for hallucinations and delusions associated with psychosis caused by Parkinson’s disease.
What is happening?
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Acadia Pharmaceuticals addressing its supplementary New Drug Application (sNDA) for NUPLAZID, which is used to treat hallucinations and delusions associated with dementia-related psychosis. In their response, FDA mentioned that they had finished reviewing the application and sent a CRL, while concluded that it could not be accepted in its current state.
According to the previous agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design, which sought to examine a large DRP patient population as a single group, the Division identified a lack of statistical significance in some dementia subgroups and inadequate numbers of patients with some less common dementia subtypes as lack of significant evidence of efficacy in order to support the approval.
The pivotal HARMONY trial for the DRP reached its preset primary and secondary endpoints, demonstrating pimavanserin’s clinical and statistical superiority over placebo, which was a prerequisite for the DRP indication. The predefined criteria did not include statistical separation by dementia subgroups or a minimum number of patients with distinct subtypes.
With ACAD’s new drug application sNDA not getting approved, it is quite possible that the stock price has declined following this disapproval. Although ACAD is working to find its way out with the cooperation of FDA to get the approval but for now it has become a matter of disinterest for investors and therefore they are not making any bets in ACAD stock.