Shares of Acadia Pharmaceuticals ($ACAD) 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.
The biotech reported that it still needs to do a significant amount of work to prepare its application, including a study of drug-drug interactions and CMC development, such as stability testing of registration batches. Provided the regulators don't surprise them with any fresh demands, Acadia says it will be ready to file near the end of 2014. The FDA's stance also signals its eagerness to get the NDA, encouraging analysts who already give the company a solid shot at an approval.
Just a few weeks ago Acadia investors cheered when investigators reported that they hit the primary endpoint in the first Phase III, demonstrating highly significant antipsychotic efficacy on a reduced 9-item SAPS-PD scale. Pimavanserin also scored well on key secondary endpoints. The drug arm was significantly less likely to suffer from hallucinations and delusions than the placebo arm and was twice as likely to rate as "very much improved" or "much improved."
The past few months have marked a major turnaround for Acadia. Biovail walked away from its partnership with Acadia three years ago, only to watch the company's shares soar over the past year as its lead program appeared headed for an approval at the FDA. Just last December Acadia cashed in on its swelling share price, raising $86 million.
"We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program," said Acadia CEO Uli Hacksell. "This represents another important step toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson's patients who suffer from the psychosis frequently associated with this disease."
- here's the press release