Six months after disappointing investors with the latest delay in their FDA application for a new Parkinson's drug, San Diego-based biotech Acadia says it's handed over the package to regulators and decided to give interim CEO Steve Davis the top job on a permanent basis.
San Diego-based Acadia Pharmaceuticals put out word on Wednesday evening that it is delaying its expected NDA for pimavanserin from Q1 back to some time in the second half of this year. And the company says its CEO is out the door.
Acadia Pharmaceuticals' shares rocketed up nearly 20% on Tuesday based on some news tied to two investor conferences. But the market wasn't reacting to anything the company said, instead reading into a pair of cancellations and deducing that a buyout might be in the offing.
The FDA has just added a fresh boost to Acadia Pharmaceuticals, naming its late-stage Parkinson's drug pimavanserin a "breakthrough" therapy deserving rapid regulatory response as it nears the finish line with a closely watched marketing application.
Shares of Acadia Pharmaceuticals shot up 44% this morning after the San Diego-based biotech announced that the FDA had signed off on a new timeline allowing the biotech to skip a confirmatory late-stage study for their Parkinson's psychosis drug pimavanserin and move straight ahead with a new drug application after tying up some loose ends in the clinic.
Shares of San Diego-based Acadia Pharmaceuticals surged 28% this morning after the biotech spelled out some of its Phase III data on pimavanserin, its experimental therapy for treating psychosis in Parkinson's patients.
Acadia Pharmaceuticals' stock jumped 10.16% to $4.88 late this morning after news of the private placement of shares for $4.43 per share that is expected to close Dec. 17.
Acadia Pharmaceuticals heralded positive pivotal data for its late-stage Parkinson's contender pimavanserin this morning, marking a big turnaround or a program that had spurred more doubt than hope when a similar Phase III effort was scuttled by a big placebo effect back in 2009.
Acadia Pharmaceuticals ($ACAD) may have struck two birds with one stone thanks to its pipeline drug pimavanserin. The drug, which is in Phase III development to treat Parkinson's disease psychosis, may also combat psychosis in Alzheimer's patients, according to the company.
Acadia Pharmaceuticals and Biovail, a subsidiary of Valeant Pharmaceuticals, said this morning that they have ended the collaboration agreement on pimavanserin, a drug for Parkinson's. Last year the