Jeffries- ACAD reiterated its expectation to file Pim in PDP & EU strategy by yr end or slightly earlier - Reiterate Buy and $38 target
ACADIA Pharm. (ACAD)
ACAD 1Q14 Update: Pimavanserin U.S. Filing and EU Strategy by end or slightly earlier - Reiterate Buy and $38 target
BUY Price target $38.00
ACAD reiterated its expectation to file pimavanserin in Parkinson’s disease psychosis (PDP) at the end of 2014, with the possibility of a slightly earlier filing. ACAD continues to guide to an update on its EU regulatory strategy by year-end. The company also focused on new efforts in sleep disturbance, which they intend to first study in Parkinson’s disease patients. We maintain our Buy rating and $38 price target.
Incremental Updates from the Call - Pimavanserin FDA and EMA Regulatory Process. ACAD has 3-month stability data on its initial three registration batches and expects 6-month stability data later in 2Q. The company’s drug-drug interaction trials have been completed as expected. The company expects a pre-filing meeting with the FDA this quarter, with filing by YE14. During this meeting, the company will discuss whether a full 12-months of stability data is necessary for filing. If the FDA accepts a shorter time frame for initial filing, there could be some modest upside to approval timing. Regarding the path in the EU, the company is in discussions with representatives from various EU member states and expects to have clarity on a path forward by the end of the year. Regarding Asia, the company expects to go down that approval path with a partner.
New Clinical Development Efforts in Sleep Disturbance. ACAD noted they intend to move forward with studies of pimavanserin for the treatment of sleep disturbances in Parkinson’s disease (PD) patients (50% of PD patients have sleep disturbances) following encouraging sleep data in PD patients seen in the PDP studies. Pimavanserin has been shown to have positive effects on daytime wakefulness and nighttime sleep that is not correlated to psychosis measures
Sentiment: Strong Buy
I generally do not admire, or place weight in what Wall Street Biotech analysts say. The exception is Thomas Wei at Jeff. He's talented and not your typical paid bear or paid bull. Looks like the short raid is over. If ACAD closes green, it will be a major, key reversal. Thanks TWei!
Obviously no one seems to care what the analysts are saying......the stock continues to be sold and the greedy insiders aren't buying, they just keep selling. after they exercise their free options!
Disagree - insiders of course need to sell some for financial planning purposes - dont want your job and AL net worth in one company - just prudent and done with a 10b5-1 plan - its fine - and they still own huge amounts...they deserve every penny.
This is a 60 dollar stock in 12 to 18 months and I am adding and liking the dip