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ACAD

Acadia

$19.08

3.97 (26.27%)

17:17
09/20/18
09/20
17:17
09/20/18
17:17

Acadia issues states affirming positive risk profile of NUPLAZID

ACADIA Pharmaceuticals announced that the FDA has completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of NUPLAZID for patients with Parkinson's disease psychosis. NUPLAZID is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP). NUPLAZID was approved by the FDA based on a pivotal Phase 3 study that demonstrated clinically robust and highly statistically significant efficacy, combined with other supportive studies. In assessing the reports of deaths, FDA considered that patients with Parkinson's disease psychosis, for whom NUPLAZID is indicated, have a higher mortality (death) rate due to their older age, advanced Parkinson's disease, and other medical conditions. Moreover, NUPLAZID is primarily distributed through a patient support program and a specialty pharmacy network, which increases the likelihood that deaths will be reported to the manufacturer. In FAERS reports that included a cause of death (many reports did not provide sufficient information to assess drug cause and effect), there was no evident pattern to suggest a drug effect. Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of NUPLAZID for Parkinson's disease psychosis. Although FDA did not identify any new or unexpected safety risks, some potentially concerning prescribing patterns were observed, such as the concomitant use of other antipsychotic drugs or drugs that can cause QT prolongation, a potential cause of heart rhythm disorder. The risk of QT prolongation and serious arrhythmia (abnormal heart rhythm) associated with NUPLAZID is noted in the Warnings and Precautions section of the drug label, which warns of the increased risks associated with using NUPLAZID together with other drugs known to cause QT interval prolongation. Based on this observation, FDA reminds health care providers to be aware of the risks described in the prescribing information. FDA also reminds heath care providers that none of the other antipsychotic medications are approved for the treatment of Parkinson's disease psychosis. Patients taking NUPLAZID for Parkinson's disease psychosis should continue to use it as prescribed by their health care provider. FDA continues to monitor reports of adverse events associated with NUPLAZID. The agency will communicate any updates to the public as necessary. To help FDA assess potential medication safety issues, we urge health care providers and patients to report suspected side effects involving NUPLAZID and other drugs to the FDA MedWatch program.

  • 01

    Oct

ACAD Acadia
$19.08

3.97 (26.27%)

09/20/18
JPMS
09/20/18
NO CHANGE
JPMS
Overweight
FDA conclusion on Nuplazid safety removes overhang on Acadia, says JPMorgan
JPMorgan analyst Cory Kasimov said he views the FDA's statement that "no new or unexpected safety risks" were found upon a review of Nuplazid's safety as a clear positive development that removes a significant overhang on the shares of Acadia. He doesn't expect commercial trends to reverse immediately and Q3 "obviously still matters, but probably not as much after today's news," Kasimov said in a note to investors. He maintains an Overweight rating on Acadia shares.
09/20/18
STFL
09/20/18
NO CHANGE
STFL
Hold
FDA safety communication removes 'worst case scenario' for Acadia, says Stifel
After the FDA completed its formerly announced review of Nuplazid and concluded that the drug's benefits outweigh its risks and its label does not need to be changed, Stifel analyst Paul Matteis called the conclusion "as good as one could expect." The news "completely removes the worst case scenario off the table," but Matteis still worries that the negative perception caused by the CNN articles that "sensationalized" the death rate of Nuplazid patients may take time to overcome. The analyst maintains a Hold rating on Acadia shares.
09/20/18
COWN
09/20/18
NO CHANGE
COWN
Outperform
Cowen says FDA news should 'go a long way' in easing Nuplazid safety concerns
After the FDA announced that it has concluded there is no new risk associated with Nuplazid, Cowen analyst Ritu Baral said she thinks the FDA's statement will go a long way in easing patient safety concerns. The analyst, who sees the FDA news as "very likely" to boost Nuplazid back to growth soon, keeps an Outperform rating on Acadia shares.
09/20/18
JMPS
09/20/18
NO CHANGE
JMPS
FDA safety review a 'signal of confidence' in Acadia drug, says JMP Securities
JMP Securities analyst Jason Butler reiterated a Market Outperform rating and $27 price target on Acadia Pharmaceuticals after the FDA reaffirmed its confidence in Nuplazid safety profile following completion of a comprehensive safety review. Butler sees this as an "important signal of confidence in the drug's safety profile" and sees this as a clearing event for the stock. He sees these catalysts driving the stock meaningfully higher in the coming months.

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