Acadia finally delivers long-delayed application for 'breakthrough' Parkinson's drug

Acadia CEO Steve Davis

The long wait at San Diego-based Acadia is over. Six months after disappointing investors with the latest delay in their FDA application for a new Parkinson's drug, the biotech says it's handed over the package to regulators and decided to give interim CEO Steve Davis the top job on a permanent basis.

Back in mid-March Acadia worked out a $616,000 going-away package for longtime CEO Uli Hacksell, as Davis moved up from the CFO's office to run the company as the board sorted out a permanent replacement. The latest delay for pimavanserin--to be sold as Nuplazid if it reaches the market--was attributed to manufacturing concerns, while last fall the company said the application simply wasn't ready on time.

The delays and the change at the top came after the biotech had whipped up considerable enthusiasm for pimavanserin, which won the FDA's hotly sought breakthrough drug designation, a category that is intended to help grease the skids to a quick regulatory decision.

With all late-stage assets getting careful attention on Wall Street in light of the current frenzy of buyouts and product deals, Acadia came in for an extra round of buyout rumors earlier in March after it canceled a pair of presentations at investor conferences.

"We are building on our momentum as we prepare for the expected launch of Nuplazid in the United States and continue our efforts to explore the full potential of Nuplazid to treat patients suffering from additional CNS disorders," Davis noted in a statement.

Davis got off to a solid start today, with the company shares trading up 9% in early trading. But those shares have been on a roller coaster ride for more than two years, dating back to the spring of 2013 when the company said the FDA would allow a straight shot at a marketing approval, bypassing a confirmatory study.

Acadia investors had 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."

CNS has been making something of a comeback in recent years. New startups and some long-term survivors in the field have been pushing programs ahead, relying on new research insights as well as better delivery tech.

- here's the release on Nuplazid
- here's the release on Davis's new job