Chelsea Therapeutics ($CHTP) 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.
Charlotte, NC-based Chelsea revealed after the close of the market Tuesday that its Phase III 306B study met the primary endpoint with a significant reduction in falls and dizziness in patients on Northera compared to those on placebo at week 1. But a problem for the drug, for which the FDA denied approval in March, has been its performance after the first week. And again in the 306B trial there was a reduction in falls and fall-related injuries for the duration of the study, but not enough to reach statistical significance.
The company's share took a spill, down nearly 25% in pre-market trading to $1.35, the latest in a series of price declines that have sent the value of shares tumbling down 67% over the past year.
Interim CEO Joseph Oliveto gave no signs of giving up on the program in the company's press release. "We look forward to more fully evaluating this rich dataset and working with key opinion leaders and health authorities to further define our path to secure marketing approval," he said.
Oliveto took the reins at Chelsea after the company made major staff cuts and waved goodbye to its CEO Simon Pedder in July following the bad news that even the 306B study wouldn't be enough for a new filing for approval from the FDA.
As Reuters noted, U.S. regulators suggested another trial and want to see how well Northera can help patients over the course of two to three months.