Chelsea Therapeutics Down 40% on FDA Update

Chelsea Therapeutics International

is trading lower on the session after it provides an update on Northera regulatory status and development program. The company said the FDA advised Chelsea that Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera Capsules New Drug Application. Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. said, "As we communicated to the FDA during our End-of-Review meeting and subsequently documented in detail as part of our proposal, we remain fully blinded to all efficacy data from Study 306B. We are deeply disappointed that the agency did not find our blinding documentation sufficient to warrant full use of Study 306B as confirmatory evidence of droxidopa's demonstrated benefits. The FDA did acknowledge the 'important need' for a safe and effective therapy for these patients and indicated they were 'anxious to work with [us] in designing a new trial,' specifically noting that many suitable trial options exist, including potentially recruiting patients directly from Chelsea's expanded access program." Chelsea Therapeutics is currently trading at $0.84, a loss of $0.62 or 42.34%