Biotech Implosion: Vanda Pharmaceuticals (VNDA)
Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing a major implosion this morning. The company has disclosed that it received a dreaded FDA not-approvable letter on its iloperidone. This was its late-stage schizoprenia candidate as well. The drug candidate is apparently too close to other drugs already on the market and the FDA said more safety data would be required to consider another application.
Vanda shares are down 59% at $1.35, which has gone from the good to the bad to the ugly. Its prior 52-week trading range was $2.70 to $19.62. Its current market cap after the drop is about $36 million. While that is well under its cash levels on the books, it will burn through much cash to fulfill its FDA obligations to proceed.
This one isn’t a biotech zombie yet, but you’d never know it if you just looked at its stock chart.
Jon Ogg
July 28, 2008
ACADIA Busts Schizophrenia Trials (ACAD)
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