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ACAD

Acadia

$25.94

0.25 (0.97%)

16:09
07/22/19
07/22
16:09
07/22/19
16:09

Acadia phase 3 Pimavanserin trial did not achieve statistical significance

ACADIA announced top-line results from its Phase 3 ENHANCE study, which evaluated pimavanserin as an adjunctive treatment in adult schizophrenia patients with persistent inadequate response to their current antipsychotic therapy. A total of 396 patients with moderate-to-severe psychotic symptoms were randomized to receive either pimavanserin or placebo added to their current antipsychotic treatment. There is currently no FDA-approved adjunctive treatment for schizophrenia patients with inadequate response to existing therapies. In the study, adding pimavanserin to existing antipsychotic treatment showed a consistent trend in improvement of psychotic symptoms, however the results did not achieve statistical significance on the primary endpoint, the Positive and Negative Syndrome Scale total score. A positive trend was also observed on the key secondary endpoint, the Clinical Global Impression-Severity score. Notably, in the full analysis set, pimavanserin showed significant improvements on two pre-specified measures of negative symptoms: the secondary endpoint PANSS negative symptoms scale sub-score and the exploratory endpoint PANSS Marder negative factor score. Pimavanserin was well-tolerated with similar rates of adverse events between adjunctive pimavanserin and adjunctive placebo. Adverse events reported in at least 5% of patients in the pimavanserin group included headache, somnolence, and insomnia. Additionally, the adjunctive use of pimavanserin did not result in clinically significant differences in vital signs, weight, metabolic syndrome, and extrapyramidal symptoms compared to adjunctive placebo. Approximately 88% of pimavanserin and 96% of placebo patients completed the study. 1% of patients in each arm reported serious adverse events. Discontinuations due to adverse events were low, 2.5% for pimavanserin and 0% for placebo.

  • 31

    Jul

  • 20

    Aug

ACAD Acadia
$25.94

0.25 (0.97%)

02/27/19
ADAM
02/27/19
NO CHANGE
Target $27
ADAM
Hold
Canaccord says Acadia shares 'getting interesting,' raises price target to $27
Canaccord analyst Sumant Kulkarni said Acadia reported decent Q4 results, with Nuplazid sales coming in in-line with expectations. The outlook was solid, suggesting the media issues the drug faced are behind it, which is encouraging, said Kulkarni. With that out of the way, the analyst believes the stock is getting more interesting heading into data readouts for the company's dementia and schizophrenia drugs. Kulkarni maintained his Hold rating and raised his price target to $27 from $23 on Acadia shares.
02/27/19
PIPR
02/27/19
NO CHANGE
Target $30
PIPR
Overweight
Acadia price target raised to $30 from $25 at Piper Jaffray
Piper Jaffray analyst Danielle Brill raised her price target for Acadia Pharmaceuticals to $30 following the company's Q4 results. The analyst expects Nuplazid' "modest" revenue growth to continue as safety concerns "slowly subside." She also anticipates a beneficial impact to 2019 sales from the ongoing direct-to-consumer campaign. As such, the company's fiscal 2019 guidance of $275M-$300M "appears in line and readily achievable," Brill tells investors in a post-earnings research note. With Acadia beginning two Phase 3 major depressive disorder trials in the first half of 2019, the analyst expects the shares to start reflecting value for the indication as the program continues to advance. She introduced probability-adjusted numbers at a 25% chance of success into her model and keeps an Overweight rating on Acadia.
05/01/19
PIPR
05/01/19
NO CHANGE
Target $35
PIPR
Overweight
Acadia price target raised to $35 from $30 at Piper Jaffray
Piper Jaffray analyst Danielle Brill raised her price target on Acadia to $35 and kept her Overweight rating after its better than expected Q1 sales of Nuplazid that was driven by "accelerated growth in new patient starts." The analyst further cites the management's increased FY19 Nuplazid midpoint sales guidance and also sees "significant unrealized value" for the company's dementia related psychosis programs.
06/11/19
PIPR
06/11/19
NO CHANGE
Target $35
PIPR
Overweight
Acadia risk/reward favorable into Phase 3 Enhance data, says Piper Jaffray
Piper Jaffray analyst Danielle Brill believes shares of Acadia Pharmaceuticals offer a favorable risk/reward into the Phase 3 Enhance trial of adjunctive Nuplazid for schizophrenia, which are expected by mid-2019. The analyst's level of conviction for a positive trial outcome remains low, but she believes investor expectations are also low and do not think the opportunity is currently reflected in Acadia's share value. She sees upside potential of 30%-35% on positive data with downside capped at 10% on a negative outcome. Brill keeps an Overweight rating on the shares with a $35 price target.

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