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.
Stocks are mixed at midday, as better than expected results from Coke are helping the Dow and the Nasdaq is slightly lower. The focus of... To see the rest of the story go to thefly.com. See Story Here
UP AFTER EARNINGS: Coca-Cola (KO), up 3%... United Technologies (UTX), up 2%... Quest Diagnostics (DGX), up 5%... Sherwin-Williams (SHW), up 2.5%... Lockheed Martin (LMT), up 1.5%... JetBlue (JBLU), up 1%. ALSO HIGHER: Chiasma (CHMA), up 22% after the company's pivotal Phase 3 OPTIMAL clinical trial met its primary and secondary endpoints... Realogy (RLGY), up 22% after announcing a collaboration with Amazon (AMZN) for the launch of TurnKey, a new homebuying program. DOWN AFTER EARNINGS: Centene (CNC), down 2%... Harley-Davidson (HOG), down 3%... Tile Shop (TTS), down 5%... Zions Bancorp (ZION), down 7%. LOWER: Acadia (ACAD), down 13% after reporting that its Phase 3 ENHANCE study did not achieve statistical significance.
JMP Securities analyst Jason Butler maintains his Outperform rating and $30 price target on Acadia even though the stock fell nearly 15% yesterday after the company's Phase 3 trial evaluating pimavanserin as an adjunctive treatment for schizophrenia did not meet its primary endpoint. The analyst says the efficacy signals still support pimavanserin's potential for success in a "more commercially attractive" symptoms setting, with the trial's data still showing "consistent positive trends in improvement of psychotic symptoms."
UP AFTER EARNINGS: Brown & Brown (BRO) up 1.0%. ALSO HIGHER: Snap (SNAP) up 2.2% after being upgraded to Buy at Stifer and initiated with Buy at Rosenblat... Intel (INTC) up 1.3%, Qualcomm (QCOM) down 2.7% after WSJ report of Apple interest in Intel's smartphone model chip business. DOWN AFTER EARNINGS: Steel Dynamics (STLD) down 5.8%... Zions Bancorp (ZION) down 4.9%... Cadence Design (CDNS) down 1.1%, Synopsys (SNPS) down 7.7 in sympathy... Whirlpool (WHR) down 0.9%... TD Ameritrade (AMTD) down 0.6%. ALSO LOWER: Acadia Pharma (ACAD) down 15.3% after its phase 3 Pimavanserin trial in schizophrenia did not achieve primary endpoint statistical significance. Movers as of 18:30ET.
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.