After releasing positive clinical data, ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) is making a run for the top in the market this morning. The data came from the company’s Phase 2 CLARITY study, assessing pimavanserin as an option for patients with MDD. With the positive data in mind, excited investors are pushing the stock upward. Today, we’ll talk about:
- The data;
- what we’re seeing from ACAD stock as a result; and
- what we’ll be watching for ahead.
ACAD Announces Positive Clinical Data
As mentioned above, ACADIA Pharmaceuticals is climbing in the pre-market hours this morning after the company announced positive clinical results from the CLARITY study. During the Phase 2 study, 207 adult patients with a confirmed inadequate response to the existing first line therapy for MDD were provided with 34 mg pimavanserin or placebo. Patients that did not show a response to placebo in stage 1 were re-randomized to receive either pimavanserin or placebo for a second five-week period.
In the release, ACAD said that pimavanserin met the primary endpoint. This endpoint was a significant reduction in the Hamilton Depression Rating Scale (HAMD-17) score compared to placebo. Also, the company said that stage 1 patients on pimavanserin demonstrated a highly significant improvement in the HAMD-17 score. The company said that this group of patients saw benefit over placebo in the first week of treatment. Stage 2 results did not demonstrate a significant separation in a small set of placebo non-responders.
The company also said that the study met its secondary endpoint, showing statistically significant reductions compared to placebo in the Sheehan Disability Scale score. Finally, the company said that the study showed the treatment to be safe and well-tolerated. In a statement, Serge Stankovic, M.D., M.S.P.H., EVP and Head of R&D at ACAD, had the following to offer:
We are pleased with the robustness of the data from our Phase 2 CLARITY trial, which shows significant promise for patients with MDD, including early and sustained antidepressant response over placebo, decreased daytime sleepiness, no meaningful weight gain, and improved sexual function. This is important because most people with MDD do not respond to initial antidepressant therapies and experience significant unwanted side effects… Pimavanserin is a selective serotonin inverse agonist, or SSIA, that shows great potential as an antidepressant. We look forward to engaging with the FDA and initiating a Phase 3 program in the first half of 2019.
What We’re Seeing From the Stock
With the positive clinical data in mind, excited investors are grabbing hold of ACADIA Pharmaceuticals, sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:58), ACAD is tradin gat $22.33 per share after a gain of $1.24 per share or 5.88% thus far today.
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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 continued work to develop pimavanserin as the treatment seems to be showing promise in the clinic. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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