From BTV board
>>>ACADIA Pharmaceuticals target raised to $16 from $9 at Needham (11.55 +3.58)
Needham raises their ACAD tgt to $16 from $9 and notes that ACAD announced this morning that, surprisingly, only one successful Phase 3 trial of pimavanserin in Parkinson Disease Psychosis (PDP) will be needed for an NDA filing. They had expected an NDA submission around mid-2015 and launch mid-2016, but believe these events may be moved up by ~9 months to late 2014 and late 2015, respectively. They view this development as another indicator of increasing flexibility at the FDA as well as recognition of the strength of the Study 020 data in PDP.
ACADIA Pharmaceuticals target raised to $15 from $9 at Ladenburg Thalmann (11.50 +3.53)
Ladenburg Thalmann raises their ACAD tgt to $15 from $9. They note that ACAD announced it plans to submit the primavanserin NDA in late 2014 without the need of an additional Phase 3 clinical trial. In their view, the news removes a significant risk which is having a second positive clinical study. In addition, they believe it could accelerate commercialization by at least one year. Crucially, they believe ACAD is now more likely to be perceived as an attractive acquisition candidate. They also believe the news represents an important milestone in CNS regulatory history as PDP could become the first time a drug is approved to treat a specific ailment within a CNS disease. They believe this could create an important precedent for future drug developers.<<<
