Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) saw its shares on the rise again this week following an incredibly positive U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) vote. The company announced that the FDA’s PDAC voted 12 to two that the benefits of Nuplazid (pimavanserin) for the treatment of Parkinson’s disease psychosis (PDP) outweigh the risks of treatment.
Previously, 24/7 Wall St. pointed out how Merrill Lynch sees Acadia growing another 60%, in relation to this study.
The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the Nuplazid New Drug Application (NDA) is May 1. The FDA has granted the Nuplazid NDA Priority Review status and designated Nuplazid for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.
About one million people in the United States and around four to six million people worldwide suffer from Parkinson’s disease. An estimated 40% of these patients have PDP, which is characterized by hallucinations and delusions, a diminished quality of life and significant caregiver burden.
Steve Davis, president and CEO of Acadia, commented:
We are very encouraged by the Committee’s positive vote today and look forward to working with the FDA as it completes its review of Nuplazid. If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease.
Shares of Acadia closed Tuesday up 17% at $23.81, with a consensus analyst price target of $44.80 and a 52-week trading range of $16.64 to $51.99. Following the release of this vote, the stock jumped another 24% to $29.60 in early trading indications on Wednesday.
Take Charge of Your Retirement: Find the Right Financial Advisor For You in Minutes (Sponsor)
Retirement planning doesn’t have to feel overwhelming. The key is finding professional guidance—and we’ve made it easier than ever for you to connect with the right financial advisor for your unique needs.
Here’s how it works:
1️ Answer a Few Simple Questions
Tell us a bit about your goals and preferences—it only takes a few minutes!
2️ Get Your Top Advisor Matches
This tool matches you with qualified advisors who specialize in helping people like you achieve financial success.
3️ Choose Your Best Fit
Review their profiles, schedule an introductory meeting, and select the advisor who feels right for you.
Why wait? Start building the retirement you’ve always dreamed of. Click here to get started today!
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
Our expert who first called NVIDIA in 2009 is predicting 2025 will see a historic AI breakthrough.
You can follow him investing $500,000 of his own money on our top AI stocks for free.