ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that it has received an FDA approval. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The FDA approval;
- what we’re seeing from ACAD as a result; and
- what we’ll be watching for ahead.
ACAD Heads For The Top On FDA Approval
As mentioned above, ACADIA Pharmaceuticals is having an incredibly strong start to the trading session this morning after announcing an FDA approval. In a press release issued early this morning, the company announced that the United States Food and Drug Administration (FDA) has approved a new capsule dose formulation and a new tablet strength of NUPLAZID (pimavanserin). The new dose and formulation are designed to help in the treatment of patients living with hallucinations and delusions associated with Parkinson’s disease psychosis.
In the release, ACAD announced that the FDA approval of a 34 mg NUPLAZID capsule formulation will provide patients with the recommended 34 mg once daily dose in a single, small capsule, reducing patient pill burden. Previously, patients were provided with two 17 mg tablets. Also, the 10 mg tablet provides an optimized lower dose strength in patients who are concomitantly receiving strong cytochrome 3A4 inhibitors. These inibitors can inhibit the metabolism of NUPLAZID. In a statement, Steve Davis, President and CEO at ACAD, had the following to offer:
We are very pleased with the FDA approval of the NUPLAZID 34 mg capsule and 10 mg tablet, underscoring ACADIA’s continued dedication to advancing safe and effective treatment options for patients living with hallucinations and delusions associated with Parkinson’s disease psychosis.
The above statement was followed up by Dr. Joseph H. Friedman from the Butler Hospital and Warren Alpert Medical School of Brown University. Here’s Dr. Friedman had to offer:
NUPLAZID is a significant advance in our treatments for the hallucinations and delusions in Parkinson’s disease… The replacement of two 17 mg tablets with a single 34 mg capsule provides a simpler and more straightforward approach for the 34 mg once daily NUPLAZID dosing regimen, while also reducing the overall pill burden for my Parkinson’s disease patients who often also take multiple other medications concomitantly.
What We’re Seeing From The Stock
One of the firstlessons that we learn when we start to dig into the market is that the news causes moves. When it comes to ACADIA Pharmaceuticals, the news proved to be overwhelmingly positive. It is believed that the new FDA dose and formulation approvals will help to increase sales surrounding NUPLAZID. So, it’s no surprise that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:05), ACAD is trading at $16.39 per share after a gain of $1.32 per share or 8.76% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ACAD. In particular, we’re interested in following the story surrounding the company’s ongoing work to ramp up sales of NUPLAZID following the news of the FDA approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!