Earlier today, I wrote about the fact that Acadia (ACAD) stock was rising high as investors speculated about a possible takeover by Allergan (AGN). The speculation was the result of delayed investor meetings and investors looking for reasons. However, it seems as though a reason has come to the table. Acadia (ACAD) announced that it would be delaying the New Drug Application for it’s drug NUPLAZID; an expected treatment for Parkinson’s disease. While the application was expected to be submitted in the first half of 2015, the company has decided to delay the submission until the second half of the year.
Reasons Acadia (ACAD) Gave For The NDA Application Delay
The reason gave for the delay is that Acadia (ACAD) simply isn’t ready for commercial manufacturing of the new drug. In a statement, the interim CEO of Acadia (ACAD), Steve Davis had the following to say…
“We have concluded that additional time is needed to complete the readiness of our commercial manufacturing systems…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.”
Should Investors Be Concerned?
Any time a new drug application is delayed, I do believe that investors should be concerned. While ineffectiveness doesn’t seem to be the reason for the delay, you’ve got to wonder what is really going on behind the scenes. With that being said, I don’t think that this is the end of the world for the company, but I do think that it’s important for investors to take these developments into consideration before making moves with Acadia (ACAD) stocks.
Acadia (ACAD) CEO Sudden Retirement
Another piece of big news that is just breaking is that the CEO of Acadia (ACAD) announced his retirement out of the blue. The company announced this afternoon that Uli Hacksell has made the decision to retire both as a member of the Acadia (ACAD) board of directors and as the company’s CEO. In the announcement, investors learned that the CEO’s retirement was effective immediately and that Chief Financial Officer, Steve Davis would be acting as the interim CEO.
While there has been quite a bit of news about Steve Davis’ qualifications as interim CEO, there hasn’t been mention of why Uli Hacksell has made the decision to retire. As you can probably imagine, the story is still breaking, so we will update you as it develops.
Should Investors Be Concerned
To me, a CEO stepping down not only as Chief, but as a chairman says quite a bit. Now, I’m not sure why he’s stepping down or what is going on behind the scenes as of yet, but this isn’t the type of development we generally see when a company is doing well.
Acadia (ACAD) Stock Reaction To The News
While the news didn’t come out early enough for it to have an affect on active trading today, in after hours trading, the stock fell 22% almost immediately and is expected to continue falling.
What Do You Think?
Do you think that Acadia (ACAD) stocks will be able to bounce back in a reasonable amount of time? Let me know in the comments below!