Acadia craters as takeover buzz is silenced by (another) NDA delay, CEO exit

Retired Acadia CEO Uli Hacksell

Those hot market-moving rumors you may have heard about San Diego-based Acadia Pharmaceuticals becoming a takeover target just got doused with a freezing cold splash of reality. The biotech 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--which stirred speculation about its fate after mysteriously exiting from two conferences--says its CEO is out the door.

Acadia ($ACAD) shares quickly fell back to earth on the postmarket closing releases, dropping more than 20% on the news. 

Uli Hacksell "retired" as CEO, effective today, and was replaced on an interim basis by CFO Steve Davis. But before he found the exit, Hacksell had worked out the terms of his departure. The longtime CEO gets $580,000 over the 18 months he'll be designated as a consultant, along with a lump-sum payment of $36,000, according to a document filed with the SEC.

"We have concluded that additional time is needed to complete the readiness of our commercial manufacturing systems," Davis noted in a statement. "While we are very disappointed with the change in timing, we believe that this is the prudent course of action to take. We are working expeditiously to ensure that our systems are robust and ready for FDA review and commercial launch. Importantly, we remain confident in the safety and efficacy package supporting the NDA of Nuplazid, which received Breakthrough Therapy designation from the FDA last year."

Investors--and board members--may have been in a particularly unforgiving mood about the latest delay, as Acadia had already put their NDA on hold once before. Last November the biotech announced that it had to delay the app to Q1 as the company had yet to finish their preparations for the pitch.

Pimavanserin is designed to treat psychosis tied to Parkinson's disease, and its midstage promise led the FDA to grant its coveted breakthrough-therapy designation, promising Acadia a speedy review and easy access to top agency officials. The company, whose market cap now sits at $4.6 billion, is working with Allergan ($AGN) on a Phase II chronic pain drug and a Phase I glaucoma therapy.

As Damian Garde reported earlier today, the biotech was scheduled to present at last week's Cowen Healthcare Conference and never showed up, and it pulled out of Tuesday's Roth Capital Partners showcase at the last minute, according to Bloomberg. That was enough to convince many investors that Acadia might be in the midst of a buyout negotiation, potentially with partner Allergan and its soon-to-be owner, Actavis ($ACT). As Garde added earlier today, though, there was never any solid reason to believe the rumors. But with unexpected takeover rumors fueling a frenzy of chatter, even small hints can be blown out of context.

- here's the release on the NDA
- here's the release on the CEO exit