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ACAD

Acadia

$19.95

0.47 (2.41%)

14:00
04/25/18
04/25
14:00
04/25/18
14:00

FDA head says will 'take another look' at Acadia's Nuplazid, CNN reports

In response to questioning at a hearing last week, FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Parkinson's drug Nuplazid after Acadia's treatment for hallucinations and delusions associated with Parkinson's psychosis was highlighted in a recent CNN report, the news agency reported. The FDA told CNN this week that the agency had already begun conducting a new evaluation, which started several weeks ago. Reference Link

ACAD Acadia
$19.95

0.47 (2.41%)

10/05/17
LEER
10/05/17
NO CHANGE
LEER
Market Perform
Acadia Dementia Psychosis BTD a positive surprise, says Leerink
Leerink analyst Paul Matteis notes that Acadia announced the initiation of a phase III study, HARMONY, assessing pimavanserin in various dementia related psychoses. The analyst says that the breadth of the patient population in this pivotal program - previously expected to focus on Alzheimer's Disease - is a "major surprise." Meanwhile, the FDA has granted Breakthrough Therapy Designation, or BTD, to pimavanserin for dementia-related psychosis, Matteis points out, adding that FDA feedback awarding breakthrough designation and allowing for a single pivotal study is encouraging. Moreover, the analyst says that if the study succeeds, the addressable population could be very large. The analyst reiterates a Market Perform rating on the shares.
11/06/17
LEER
11/06/17
NO CHANGE
Target $35
LEER
Market Perform
Data suggests Acadia pivotal DRP program is high risk, says Leerink
Following full data from Acadia's phase 2 study of pimavanserin in Alzheimer's Disease Psychosis patients at the Clinical Trials on Alzheimer's Disease, Leerink analyst Paul Matteis says his cautious view on the company's phase 3 dementia related psychosis program remains as the statistically significant benefit for pimavanserin seen at the primary endpoint of 6 weeks was in his view helped considerably by a temporary regression in placebo response, this dynamic was also the case in a featured, more severe subgroup, and dementia related psychosis is a chronic condition, and for any new medication a sustained clinical benefit will be important. He reiterates a Market Perform rating and $35 price target on the shares.
04/10/18
JPMS
04/10/18
NO CHANGE
Target $50
JPMS
Overweight
Acadia sees little impact from CNN article, says JPMorgan
JPMorgan analyst Cory Kasimov says Acadia Pharmaceuticals management stressed to him their confidence that yesterday's CNN article would have little impact on Nuplazid's commercial prospects. Kasimov says that while management believes the news changes nothing, he worries "that the already tenuous sentiment around the name could have a difficult time withstanding this latest development." It remains to be seen what extent, if any, the creased scrutiny on the safety profile of Nuplazid negatively impacts the product's commercial outlook, Kasimov tells investors in a research note. He believes Acadia'a Q1 earnings report now has even greater significance. The analyst keeps an Overweight rating on Acadia with a $50 price target.
04/10/18
COWN
04/10/18
NO CHANGE
Target $50
COWN
Outperform
Acadia pimavanserin concerns a reason for caution, says Cowen
Cowen analyst Ritu Baral noted yesterday's media report concerning deaths in the Acadia pimavanserin FAERS log. The analyst said based on conversations with key opinion leaders who have major experience with pimavanserin, she thinks there is unlikely a safety signal. However, she does say the concerns keep her cautious on the stock. Baral maintained her Outperform rating and $50 price target on Acadia shares, which dropped 23% to close at $16.50 yesterday.

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FB

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ACAD

Acadia

$18.77

3.66 (24.22%)

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Acadia analyst commentary  »

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GLW

Corning

$36.24

0.98 (2.78%)

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SYK

Stryker

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-0.56 (-0.32%)

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AMZN

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PAGS

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