After riding high on the news of positive data from a recent Phase IIb trial, shares of Cardiome Pharma swiftly sank 30 percent after investors heard that the FDA's "approvable" letter for Kynapid (vernakalant)--co-developed with Astellas--included a request for more information on the drug's impact on a subset of patients in trials and a safety update on users.
"Astellas will be in contact with the FDA within the next few days to discuss next steps, and we expect that several months may be required to assemble a complete and appropriate response," stated Bob Rieder, CEO and chairman. "While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data."
- check out the Cardiome's release [1]
- read the report [2] from the Globe and Mail
Related Articles:
Cardiome delays analysis [3]
Cardiome, Astellas get panel date [4]
Cardiome's CBO discusses changes at FDA [5]
Links:
[1] http://www.marketwatch.com/news/story/cardiome-astellas-announce-receipt-fda/story.aspx?guid=%7BBE2C27E1-3012-4285-9BBB-C5E5A5E6A163%7D&dist=hppr
[2] http://www.theglobeandmail.com/servlet/story/RTGAM.20080811.WBmarkets20080811100848/WBStory/WBmarkets
[3] http://www.fiercebiotech.com/story/spotlight-cardiome-delays-analysis/2007-11-26
[4] http://www.fiercebiotech.com/story/spotlight-cardiome-astellas-get-panel-date/2007-08-30
[5] http://www.fiercebiotech.com/story/cardiome-s-cbo-discusses-changes-at-fda/2008-03-28