|Regado Biosciences CEO Dave Mazzo|
The FDA has stamped a full clinical hold on a trial Regado Biosciences ($RGDO) had voluntarily paused, shouldering its way into any discussion of resuming the study and sending the biotech's battered shares down further.
Last week, Regado revealed that "serious adverse events related to allergic reactions" had cropped up in its costly Phase III study of the anticoagulant Revolixys, formerly REG1. The company halted enrollment so that its data and safety monitoring board (DSMB) could take a look at results from the planned 13,000-patient study, news that roughly halved its share price.
Now the FDA has stepped in and imposed an official clinical hold on the study, a move designed to formalize the agency's involvement in any future decisions on Revolixys, Regado said.
"As announced earlier, we remain blinded to REGULATE-PCI study data and are awaiting the outcome of the full safety and efficacy analysis, including an analysis of benefit/risk ratio, being performed by our (DSMB)," CEO David Mazzo said in a statement. "Any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based on the DSMB's conclusions and would always be implemented in agreement with FDA."
Mazzo has said he figures the DSMB's review will take about 8 weeks.
Revolixys' latest hurdle sent Regado's shares down another 9%, and, at around $2.45 on Thursday morning, the company is trading at less than half the value of its August IPO.
A protracted delay for the drug could put Regado in a difficult financial situation as it stares down a roughly $150 million bill for the ambitious Phase III program.
To cover costs, the biotech pulled in $47 million in its IPO after boosting its offering and taking a deep discount, adding that cash to $51 million in venture funding closed last year. But Regado has acknowledged that it will need to either partner up or go back to the well to finish the process, and the plan was to execute on Phase III, educate investors and then resurface with promising results and open ears.
Now, with an up-in-the-air clinical program and smarting share price, following through won't be easy.
Revolixys is a two-component anticoagulant, combining pegnivacogin and anivamersen to control bleeding during coronary interventions and open-heart surgeries, ideally making for faster, safer procedures.
- here's the release