==Acadia Pharmaceuticals (ACAD) : schizophrenia drug study falls short

 

Pharmaceuticals announces top-line results from the Phase 3 ADVANCE-2 trial evaluating pimavanserin for the treatment of negative symptoms of schizophrenia 

• Pimavanserin did not demonstrate a statistically significant improvement over placebo on the study's primary endpoint, the change from baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16) total score (-11.8 vs. -11.1; p=0.4825; effect size=0.07). The safety and tolerability profile of pimavanserin was consistent with previous clinical trials, showing a low rate of adverse events.
• "We are disappointed the trial did not meet its primary endpoint given the significant unmet need in patients with negative symptoms of schizophrenia," said Steve Davis, Acadia's Chief Executive Officer. "We will continue to analyze these data with our scientific advisors, but we do not intend to conduct any further clinical trials with pimavanserin. We want to thank the patients, their families, and the investigators for their contributions in this important study."

==ACADIA Pharmaceuticals (ACAD) acquires ex-North American rights to Trofinetide and global rights to Neuren's NNZ-2591

This week's biggest % winners & losers : Sept 17 - 21, 18 (wk 38)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: ACAD (20.17 +45.32%), CRBP (6.95 +40.4%), MDXG (6.33 +26.6%), CCXI (12.91 +17.9%)
• Materials: GSV (1.77 +18%)
• Industrials: GOL (5.66 +24.67%), NXEO (12.42 +23.71%), SCS (19.05 +23.7%)
• Information Technology: UEPS (7.65 +19.16%), SPWR (7.89 +17.76%)
• Financials: BFR (12.13 +39.59%), GGAL (29.76 +39.07%), SUPV (9.34 +34.58%), BMA (48.5 +23.25%)
• Energy: TGS (16.94 +17.15%)
• Consumer Staples: AVP (2.44 +20.79%)
• Utilities: PAM (37.77 +29.35%)

This week's top 20 % losers

• Healthcare: ENZ (4.09 -15.15%), RGNX (69.35 -14.59%), NTLA (26.78 -13.75%), ADMS (19.17 -12.39%), QDEL (64.84 -11.64%), ALDR (16.1 -11.54%), FLXN (18.43 -11.05%)
• Materials: BCC (38.15 -12.3%), VHI (2.85 -11.21%)
• Industrials: CPRT (52.58 -18.9%), SSW (8.06 -12.1%), APOG (43.01 -11.94%)
• Information Technology: NTNX (46.45 -11.52%), HDP (22.58 -11.45%), EGOV (14.55 -10.74%)

-=Acadia Pharmaceuticals (ACAD): FDA finds drug has no additional safety problems

Acadia Pharmaceuticals (ACAD) stock spiked 19.3% in extremely heavy Thursday afternoon trade after the U.S. Food and Drug Administration found that its drug, Nuplazid, continued to have more benefits than risks for patients. Nuplazid is an antipsychotic medication used for the hallucinations and delusions connected to Parkinson's disease psychosis, but concerns had been raised by caregivers, health care providers and health watchdogs that the drug wasn't helping and might even be hurting patients, according to a CNN report. The FDA based its determination on postmarketing reports -- the drug was first launched in the U.S. in May 2016 -- as well as other data, and said it did not find "any new or unexpected safety findings." More than 8,000 cases of side effects have been reported by individuals taking Nuplazid to the FDA's Adverse Events Reporting System (FAERS), which was one of the sources reviewed by the regulator, including around 2,700 serious cases and nearly 1,150 death cases. But the FDA said that Nuplazid and others of its kind already have warnings on their boxes indicating a higher risk of death in elderly patients, and the agency considered that individuals with Parkinson's disease psychosis are more at risk of death due to their age, disease and other medical conditions. Nuplazid brought in net sales of around $125 million last year, according to Acadia's financial filings. Company shares have surged nearly 6% over the last three months, compared with a 6% rise in the S&P 500 SPX, +0.75% and a 8.2% rise in the Dow Jones Industrial Average DJIA, +0.91%

=ACADIA Pharmaceuticals (ACAD) reported earnings on Tue 8 Aug 2017 (a/h)

ACADIA Pharmaceuticals beats by $0.17, beats on revs

• Reports Q2 (Jun) loss of $0.55 per share, $0.17 better thanthe Capital IQ Consensus of ($0.72); revenues rose 30400.0% year/year to $30.5 mln vs the $20.02 mln Capital IQ Consensus. 
• Recent Highlights Conducted End-of-Phase II meeting with the FDA on the Alzheimer's disease psychosis (AD Psychosis) program. Abstract of Phase II data with pimavanserin for AD Psychosis was accepted for presentation at the Clinical Trials on Alzheimer's Disease meeting in early November 2017.

=Acadia Pharmaceuticals Inc. (ACAD) reported earnings on Tue 8 Nov 2016 (b/o)

SAN DIEGO (AP) _ Acadia Pharmaceuticals Inc. (ACAD) on Monday reported a loss of $71.6 million in its third quarter.

On a per-share basis, the San Diego-based company said it had a loss of 61 cents. Losses, adjusted for stock option expense, were 49 cents per share.

The results topped Wall Street expectations. The average estimate of seven analysts surveyed by Zacks Investment Research was for a loss of 55 cents per share.

The drugmaker posted revenue of $5.3 million in the period.

Acadia shares have declined 36 percent since the beginning of the year. In the final minutes of trading on Monday, shares hit $22.99, a fall of 45 percent in the last 12 months.

=ACADIA Pharmaceuticals (ACAD) reported earnings on Mon 29 Feb 2016 (b/o)

ACADIA Pharmaceuticals misses by $0.03, beats on revs; reaffirms May 1 PDUFA for NUPLAZID :

• Reports Q4 (Dec) loss of $0.45 per share, $0.03 worse than the Capital IQ Consensus of ($0.42); revenues fell 63.8% year/year to $0.02 mln vs the $0 mln Capital IQ Consensus.
• At December 31, 2015, ACADIA's cash, cash equivalents, and investment securities totaled $215.1 million compared to $322.5 million at December 31, 2014. Net proceeds of approximately $281.6 million received from ACADIA's follow-on public offering in January 2016 are not reflected in the balance sheet as of December 31, 2015.

Long trade : ACAD +15% (4/15)