ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
ACADIA Pharmaceuticals is having an incredible day in the market today after announcing that the United States Food and Drug Administration has accepted the review of its new drug application for its leading candidate for the treatment of psychosis associated with Parkinson’s disease. Today, we’ll talk about the treatment and NDA acceptance, how the market reacted to the news, and what we can expect to see from ACAD moving forward.
FDA Accepts Review Of ACADIA’s NUPLAZID
ACADIA Pharmaceuticals announced today that it has received word from the FDA with regard to its New Drug Application for NUPLAZID; the FDA has accepted the NDA for review. More importantly, the FDA has granted the application a Priority Review. This means that it will be reviewed faster as a result of the overwhelming need for the treatment in the medical field. Ultimately, Priority Review is only granted to treatments for ailments which have no adequate therapy at the moment. This reduces the approval time from 10 months to 6 months. NUPLAZID is a drug designed to treat psychosis in patients with Parkinson’s disease. In 2014, ACADIA was granted Breakthrough Therapy designation for the treatment by the FDA. In a statement, Steve Davis, ACAD President and CEO had the following to say:
“The FDA Priority Review designation underscores the potential for NUPLAZID to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy… We look forward to working with the FDA During the review.”
How ACAD Reacted To The News In The Market
As we’ve come to expect any time a biotechnology company releases positive news with regard to an experimental treatment, ACAD is climbing in the market today. Currently (10:44), the stock is trading at $37.52 per share after a gain of 7.75% so far today.
What We Can Expect To See Moving Forward
Moving forward, I’m expecting to see overwhelmingly positive news out of ACAD. First and foremost, let’s talk about the treatment at hand. It is rare that the FDA accepts the review of a new drug application to decline the application down the road; it does happen, but it’s rare. Adding to the strength of this application, ACADIA’s treatment is a first-in-class treatment offering a much needed therapy to patients. As a result, last year it received Breakthrough Therapy designation and now it has it has received a Priority Review. The reality is that, in this particular case, all signs point to an approval. As we’ve come to expect, any time a new drug is approved, it acts as a catalyst for the stock. That’s exactly what I’m expecting to see when the FDA approves NUPLAZID. So, ACAD investors have plenty to look forward to.
What Do You Think?
Where do you think ACAD is headed and why? Let us know in the comments below!