On Friday, an FDA review of the biopharmaceutical company's Nuplazid drug found that it "minimally" improved hallucinations and delusions caused by Parkinson's disease, while also exposing patients to a "substantial safety" risk, TheStreet's Adam Feuerstein wrote earlier this morning.
San Diego-based Acadia said the drug "provides clinically meaningful benefit, with robust improvements observed across multiple measures of psychosis that were achieved without causing adverse effects on motor function."
Nuplazid also demonstrated an "acceptable tolerability profile and well characterized safety risks," Acadia wrote in a brief on Friday.
A panel of outside experts chosen by the FDA will meet on Tuesday to discuss the conflicting characterizations of the drug, Feuerstein added.
At the end of the meeting, the panel will vote on whether or not Nuplazid should be approved for the treatment of psychosis in Parkinson's patients.
A positive decision would likely compel the FDA to approve the drug by its decision date of May 1, Feuerstein noted.
Parkinson's is a progressive disorder of the nervous system, which affects movement.
About 5.78 million of Acadia's shares were traded by this morning, well above its average volume of 2.19 million shares per day.
Separately, TheStreet Ratings Team has a Sell with a ratings score of D on the stock.
This is driven by some concerns, which should have a greater impact than any strengths, and could make it more difficult for investors to achieve positive results compared to most of the stocks covered by the team.
The company's weaknesses can be seen in multiple areas, such as its feeble growth in its earnings per share, deteriorating net income, disappointing return on equity, weak operating cash flow and generally disappointing historical performance in the stock itself.
Recently, TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this articles's author.
You can view the full analysis from the report here: ACAD