ACADIA Pharmaceuticals ACAD Stock News

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) is rocketing in the market this morning, and for good reason. The company said that it stopped a late-stage clinical trial early because it had already met its primary endpoint. Here’s the scoop:

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ACAD Stock Rockets On Study Update

In a press release issued early this morning, ACADIA Pharmaceuticals said that a key late-stage trial met its primary endpoint. The trial, known as HARMONY was a Phase 3 study of pimavanserin.

The trial was designed to assess the potential of pimavanserin as a potential option for patients with dementia-related psychosis. In the release, ACAD said that the study demonstrated a highly statistically significant longer time to relapse of psychosis in pimavanserin-treated patients, meeting its primary endpoint.

While the trial wasn’t planned to be completed this early, the company said that at the reconmmendation of the study’s indepentdent data monitoring committe, the trial will be stopped immediately. The stoppage was based on pre-specified stopping criteria requiring a one-sided p-value less than 0.0033 on the study’s primary endpoint.

In lamens terms, the drug proved to be so effective early on that further study would only lead to redundant data. As such, the company believes that it has all that it needs to move forward with development and regulatory submission.

Talking about regulatory submission, ACAD said that it plans on meeting with the FDA in soon. The meeting will be to discuss a sumpplemental NDA submission of the treatment, planned for 2020 based on the results of the HARMONY trial.

In a statement, Serge Stankovic, M.D., M.S.P.H., President at ACADIDA Pharmaceuticals, had the following to offer:

We are very excited that today’s results bring us one step closer to the potential of offering patients with dementia-related psychosis a critically needed treatment option. We look forward to speaking with the FDA about a supplemental new drug application to support pimavanserin for the treatment of dementia-related psychosis. I want to thank all of the patients, their families, and the investigators for their participation in this important study.

This News Is Huge!!!

The news announced by ACAD today is massive for the company and its investors. First and foremost, it’s important to keep in mind that pimavanserin was granted Breakthrough Therapy Designation by the FDA.

This is important as this designation provides the company with further support from the FDA in the regulatory submission of the drug, and faster approval times. Considering the strong results, an application for approval is likely coming soon, opening the door to a compelling revenue opportunity.

Speaking of revenue, should the drug be approved by the FDA, the opportunity for ACAD here is a tremendous one. By the year 2026, Coherent Market Insights predicts that, the dementia drugs market will grow to be worth more than $28 billion annually. For a company with a market cap of just over $155 million, tapping into such a large market could be game changing!

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