Cardiome shares plunge on approvable letter

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
- read the report from the Globe and Mail

Suggested Articles

LianBio aims to bring much-needed new drugs to China and serve as a partner for U.S. biotechs looking to expand into Asia.

Despite the setback, Fulcrum hailed the data as “very encouraging,” zeroing in on results from a pre-specified sensitivity analysis to make its case.

Bayer has struck a $425 million upfront deal to buy KaNDy in the belief its treatment for menopause-related hot flashes has blockbuster potential.