Chelsea shares nosedive on FDA's questions about key drug

Chelsea Therapeutics ($CHTP) CEO Simon Pedder sat on the hot seat this morning after his company's update on an ongoing FDA review of its lead drug Northera sparked concerns among some investors and analysts. Chelsea's chief spoke about the hypotension drug during the BIO CEO conference today on the heels of the worrying update.

The news sent Chelsea's shares down more than 40% at certain points this morning and its stock traded down 30.26% to $3.48 as of 11:54 a.m. EST today.

In FDA briefing documents, regulators highlighted their previously discussed concerns about the company's Northera program such as the short duration and small size of clinical trials for the drug, for which Chelsea is seeking approval to combat cases of neurogenic orthostatic hypotension in patients with Parkinson's disease and others with primary autonomic failure. U.S. regulators previously gave the company orphan status for the treatment and priority review back in November because of the lack of effective treatments for the condition, which causes dangerous drops in blood pressure when patients stand up, Reuters reported.

Among the agency's concerns about the program is the tricky business of quantifying symptomatic and clinical benefits. Because of this difficulty, and after talking to regulators in 2007, Chelsea has been measuring the effect of its drug with a patient-reported questionnaire that rates some of the symptoms of the disease such as low blood pressure, according to the company.

The FDA is expected to take action on Chelsea's application for Northera by March 28.

- see the Reuters article
- and The Wall Street Journal's report

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