ACADIA Pharmaceuticals (ACAD) Makes Weak Move On Update

October 6, 2009 · Filed Under Cancer · Comments Off 

It seems like terribly unimportant information. ACADIA Pharmaceuticals (ACAD) is trading higher on news that provided an update on its Phase III program with pimavanserin for Parkinson’s disease psychosis (PDP), which is being pursued in collaboration with Biovail Laboratories International SRL (“Biovail”), a subsidiary of Biovail Corporation. Following the announcement on September 1st of disappointing top-line results from the first Phase III PDP trial, ACADIA and Biovail remain committed to the successful development of pimavanserin and have established a development strategy that they believe will strengthen the PDP program. The parties also intend to pursue adjunctive therapy with pimavanserin for schizophrenia as a third indication in the collaboration.

Hardly a reason for the shares to $1.87 which is up 13%. At least that is well below the 52-week high of $6.

Douglas A. McIntyre

ACADIA Pharmaceuticals (ACAD) Down 70% In Heavy Trading

September 1, 2009 · Filed Under R&D · Comments Off 

ACADIA Pharmaceuticals (ACAD) proved that whatever can go wrong will go wrong.

The firm announced that top-line results from the first pivotal Phase III trial with pimavanserin in patients with Parkinson’s disease psychosis, or PDP. The study did not meet its primary endpoint of antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Pimavanserin met the key secondary endpoint of motoric tolerability as measured using the Unified Parkinson’s Disease Rating Scale, or UPDRS. Pimavanserin was safe and well tolerated, with the frequency of adverse events generally similar in the pimavanserin and placebo arms. Read more

Have Acadia Pharma shares rallied to far, too fast? (ACAD, LLY, AZN, BVF)

July 27, 2009 · Filed Under General · Comments Off 

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) have roughly doubled over the past two trading days on expectations  that the Phase III clinical data for its Parkinson’s related psychosis candidate pimavanserin will be released soon, and the trial will meet its primary endpoint.

Institutional investors are piling on heavily in the options market on nearly 20 times average volume, as the stock’s chart now shows breakout potential to $8.

Top-line results for the first of two Phase III trials is expected by the end of the third quarter, which has the market positioning for potentially positive news in coming days.

Last April, pimavanserin met the endpoint of the study as it did not worsen Parkinson’s symptoms. The candidate was well tolerated by test subjects. It also showed promise as a co-therapy for schizophrenia in a Phase II study back in March 2007.

Nearly $16.7 billion will be spent in the U.S. this year on medications to treat mental illnesses including bipolar disorder schizophrenia, according to Thomson Pharma. The top drug in the antipsychotic category is the bipolar disorder drug Seroquel, made by AstraZeneca plc (NYSE: AZN), with expected sales of $5.4 billion, accounting for about a third of all antipsychotic drug sales. The No. 2 drug in the category is Eli Lilly & Co.’s  (NYSE: LLY) Zyprexa, for treating bipolar disorder and schizophrenia. Expected sales this year are $4.6 billion.

Has the stock rallied too much? Perhaps. The stock has added nearly $90 million in market value over the past two sessions. The speculative rise in value comes on anticipation that the candidate could find a market among a potential market of only 600,000 patients in the U.S. But pimavanserin may only have a small portion of that market, especially at the beginning.

The market now appears to be pricing in expectations that pimavanserin will find a specialized market in Parkinson’s patients, as well as a larger market in treating Alzheiemer’s disease psychosis. If approval were granted for both conditions, the drug could then reach a potential market of  2.5  million patients or more.

That however, is not likely to happen for several more years, if it happens at all.  – Mike Tarsala

ACADIA Busts Schizophrenia Trials (ACAD)

June 16, 2008 · Filed Under General · Comments Off 

ACADIA Pharmaceuticals (NASDAQ: ACAD) is going to be in for a rough day. The company announced that the results from its ACP-104 phase IIb schizophrenia trial did not meet its primary endpoint. Not only did the study fail to meet its primary endpoint of anti-psychotic efficacy, it looks like it failed to meet any of the secondary endpoints in the study. The company noted that neither dose of ACP-104 demonstrated improved efficacy as compared to placebo. That’s always a problem.

The most common adverse events in the treatment arms relative to placebo were increased salivation, tachycardia, and dyspepsia, which were noted to be dose-related. There was no clinically significant decrease in neutrophil counts in the study drug arms.

Shares are currently halted after closing at $8.49 on Friday, while its 52-week trading range is $7.63 to $17.33. Its $314 million market cap is likely to come down significantly as it has about $106 million in liquidity (before $14.65 million in liabilities) as of March 31.

Jon C. Ogg
June 16, 2008

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