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ACAD

Acadia

$21.53

-0.6 (-2.71%)

08:41
04/09/18
04/09
08:41
04/09/18
08:41

Reports of deaths among patients on Acadia drug raises concerns, CNN says

An FDA advisory committee voted 12-2 that Nuplazid's benefit was enough to merit approval of the Parkinson's drug, even though the physician who led the FDA's medical review, Dr. Paul Andreason, warned that patients taking the drug during Acadia Pharmaceuticals' trials experienced serious outcomes, including death, at more than double the rate of those taking placebo, said CNN in a newly-published investigative report. In November, an analysis released by the Institute for Safe Medication Practices, a nonprofit health care organization, warned that 244 deaths had been reported to the FDA between the drug's launch and March 2017, CNN added. Since the institute released its analysis, FDA data shows that the number of reported deaths has risen to more than 700, with Nuplazid the only medication listed as "suspect" in at least 500 of the death reports, according to CNN. Shares of Acadia are down 16% to $18 in pre-market trading following CNN's report on Nuplazid. Reference Link

ACAD Acadia
$21.53

-0.6 (-2.71%)

10/05/17
JMPS
10/05/17
NO CHANGE
Target $50
JMPS
Outperform
Acadia price target raised to $50 from $47 at JMP Securities
JMP Securities analyst Jason Butler noted that Acadia's Phase 3 HARMONY trial of pimavanserin is a relapse prevention study, which he contends optimizes the timelines and the potential for success. Butler, who increased his probability of success in the indication of dementia-related psychosis to 65% from 50%, raised his price target on Acadia shares to $50 from $47 and keeps a Outperform rating on the stock.
10/05/17
BOFA
10/05/17
NO CHANGE
Target $46
BOFA
Buy
Acadia price target raised to $46 from $40 at BofA/Merrill
BofA/Merrill analyst Tazeen Ahmad raised Acadia's price target to $46 from $40 based on Nuplazid's opportunity for further expansion and continued positive physician feedback on Nuplazid in PDP. The analyst rates Acadia a Buy.
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.

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