In its second trip through the FDA, Chelsea Therapeutics' antidizziness drug came out a winner, securing approval to fight faintness in patients with a rare disorder, but not without a daunting label and some strings attached.
Once again a group of outside FDA experts has shrugged off the agency's concerns about Chelsea Therapeutics' drug Northera (droxidopa) and voted to recommend an approval. And once again investors were thrilled to see the endorsement, sending shares of the biotech up about 150% on the lopsided 16-to-1 win.
Chelsea Therapeutics was struggling to overcome a series of setbacks a year ago, which had been crowned by the FDA's rejection of Northera (droxidopa). And then the biotech made a surprise announcement.
In another setback for Chelsea Therapeutics, drug regulators have identified certain technical deficiencies for the biotech's lead investigational therapeutic Northera (droxidopa) in a review of the company's resubmitted New Drug Application.
Last summer Chelsea Therapeutics did some painful belt tightening after its stock price plunged following the FDA's decision to reject its application for Northera (droxidopa), saying the biotech would have to pull off another study of its experimental drug before it could win an OK.
Chelsea Therapeutics failed to impress investors with the latest batch of data from a Phase III program for experimental drug Northera. The struggling biotech was unable to show statistical significance in reduction of falls and injuries in Parkinson's patients on the drug, precipitating yet another drop in the company's stock price in after-hours trading.
Struggling to find a way forward for droxidopa (Northera) after the FDA rejected its application for the lead program, Chelsea Therapeutics ($CHTP) today broadly outlined some big changes at the little biotech.
Chelsea Therapeutics' stock ($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.
Hit with a pair of pipeline setbacks recently, Chelsea Therapeutics has opted to reduce worker pay and cut compensation for its top brass to extend its cash runway and fuel development of its experimental drug Northera.
The developer says that its rheumatoid arthritis candidate CH-4051 failed to outperform the standard of care for the disease in a mid-stage study, forcing it to ax the program.