Chelsea Therapeutics' stock ($CHTP) took yet another drubbing today after the biotech spread the word that the FDA wants to see results from another clinical trial before it can approve Northera, or droxidopa, to prevent dizziness and fainting among patients with disorders of the nervous system. Shares plunged 47% on the release.
Regulators, Chelsea noted, were simply not convinced by the data that they saw in the application, citing concerns about the apparent exclusion of the results on 109 patients involved in the study. Therefore another trial would be needed to "'demonstrate that droxidopa has a significant and persistent effect' on symptoms of neurogenic orthostatic hypotension."
"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," says Chelsea CEO Simon Pedder. "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 had hoped that the data from an ongoing trial could be used to address the FDA's demand for more data. The FDA rejected Northera in March and soon after was forced to dump its RA drug after it flunked a mid-stage study. The steady stream of bad news has eviscerated the company's shares, which are trading under $1 this morning.
- read the press release
- here's the report from Bloomberg