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ACAD

Acadia

$24.97

-0.69 (-2.69%)

12:44
05/19/19
05/19
12:44
05/19/19
12:44

Acadia presents Phase 2 CLARITY results for Pimavanserin

Acadia Pharmaceuticals presented data from its Phase 2 CLARITY study, which evaluated the efficacy, safety, and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder at the 2019 American Psychiatric Association Annual Meeting. The Phase 2 CLARITY study was a 10-week, randomized, double-blind, placebo-controlled, multi-center, two-stage sequential parallel comparison design study that evaluated the efficacy, safety, and tolerability of pimavanserin. Pimavanserin was administered as an adjunctive treatment in patients with MDD who had an inadequate response to a stable dose of standard antidepressant therapy with either a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor. The study randomized 207 patients across 27 clinical research centers in the U.S. and was conducted in collaboration with the Massachusetts General Hospital Clinical Trials Network and Institute. In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing the 17-item Hamilton Depression Rating Scale total score compared to placebo. On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score. Positive results were also observed for seven other secondary endpoints, including improvement in daytime sleepiness as measured by the Karolinska Sleepiness Scale and improvement in sexual function as measured by the Massachusetts General Hospital Sexual Functioning Index. On April 25, ACADIA announced it had initiated its Phase 3 CLARITY program for pimavanserin as an adjunctive treatment for MDD. The CLARITY-2 study will be based in the U.S. and has already initiated enrollment and the CLARITY-3 study will be based outside the U.S. and will initiate enrollment in the upcoming months. Both studies are six-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD who have an inadequate response to standard antidepressant therapy with either a SSRI or a SNRI.

ACAD Acadia
$24.97

-0.69 (-2.69%)

12/10/18
ADAM
12/10/18
INITIATION
Target $23
ADAM
Hold
Acadia initiated with a Hold at Canaccord
Canaccord analyst Sumant Kulkarni initiated Acadia Pharmaceuticals with a Hold rating and $23 price target. In a research note to investors, Kulkarni says that while he believes Acadia is a core holding for investors seeking exposure to central nervous system, or CNS, companies with commercial assets, he believes the risk/reward on the stock is balanced ahead of potential issuance of the company's initial 2019 outlook for Nuplazid in Parkinson's Disease psychosis, or PDP, and views his sales estimate for Nuplazid as "reasonable," though he admits he has low visibility heading into the event.
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.

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