Trade with Eva: Analytics in action >>

Thursday, September 20, 2018

-=Acadia Pharmaceuticals (ACAD): FDA finds drug has no additional safety problems


Acadia Pharmaceuticals (ACAD) stock spiked 19.3% in extremely heavy Thursday afternoon trade after the U.S. Food and Drug Administration found that its drug, Nuplazid, continued to have more benefits than risks for patients. Nuplazid is an antipsychotic medication used for the hallucinations and delusions connected to Parkinson's disease psychosis, but concerns had been raised by caregivers, health care providers and health watchdogs that the drug wasn't helping and might even be hurting patients, according to a CNN report. The FDA based its determination on postmarketing reports -- the drug was first launched in the U.S. in May 2016 -- as well as other data, and said it did not find "any new or unexpected safety findings." More than 8,000 cases of side effects have been reported by individuals taking Nuplazid to the FDA's Adverse Events Reporting System (FAERS), which was one of the sources reviewed by the regulator, including around 2,700 serious cases and nearly 1,150 death cases. But the FDA said that Nuplazid and others of its kind already have warnings on their boxes indicating a higher risk of death in elderly patients, and the agency considered that individuals with Parkinson's disease psychosis are more at risk of death due to their age, disease and other medical conditions. Nuplazid brought in net sales of around $125 million last year, according to Acadia's financial filings. Company shares have surged nearly 6% over the last three months, compared with a 6% rise in the S&P 500 SPX, +0.75% and a 8.2% rise in the Dow Jones Industrial Average DJIA, +0.91%

No comments:

Post a Comment