UPDATE 1-CV Therapeutics awaiting FDA regadenoson decision
Fri Mar 14, 2008 4:44pm EDT Email | Print | Share| Reprints |
LOS ANGELES, March 14 (Reuters) - CV Therapeutics (CVTX.O: Quote, Profile, Research) said on Friday it expects the U.S. Food and Drug Administration to respond to its application for heart imaging agent regadenoson within the next few weeks, rather than today's deadline for a decision.
The company's statement in a regulatory filing sent its shares down 8 percent in after hours trading.
CV Therapeutics said the FDA may miss deadlines if the agency does not have sufficient resources to complete reviews.
The company also continues to expect FDA approval and that the timeline for a launch by its commercial partner Astellas Pharma Inc (4503.T: Quote, Profile, Research) would not be affected if approval is received within the next few weeks.
The companies are seeking to sell regadenoson for use as a stress agent during certain cardiovascular tests to gauge whether a patient's heart is getting enough blood to function properly.
Under the deal with the U.S. unit of Japan's Astellas, CV Therapeutics will retain all rights to the product outside of North America while Astellas will market it in the United States.
Shares of Palo Alto, California-based CV Therapeutics, which fell 11 cents, or 1.7 percent, to close at $6.30 on the Nasdaq, were down another 8 percent at $5.80 in after hours trading. (Reporting by Deena Beasley and Susan Heavey; Editing by Derek Caney) |
