Duke spin-out Regado Biosciences has had to halt its clinical trial.
Regado Biosciences, a drug developer spun out of Duke University, witnessed its shares crash by 60% on July 3, 2014 when it had to halt its clinical trial to review safety data. The shares have not been recovering, hovering around $2.60 to $2.80 down from its all-time high of $14.10.
Regado was set up in 2001 and only celebrated its initial public offering in August 2013. It raised $43m then, at $4 a share – down from the targeted $5. The company closed its latest round, a series E, in 2012, and currently has a total of $177m in funding. The total costs for the trial are estimated at $150m. The company was hoping its current funding would see it through to the first quarter of 2015, although that is now questionable.
The drug currently causing the company a headache is Revolixys Kit. It is being tested in a phase 3 trial, and is being used by heart surgeons during procedures that involve the mechanical opening or widening or coronary arteries. During the trial, safety concerns arose when it emerged that the drug may have allergic reactions as a side effect.
The company is expecting the safety review to last another four weeks. The drug has been granted “fast track” designation by the US Food and Drug Administration (FDA). The designation is given to drugs that the FDA considers an under-served but necessary therapeutic area.
The trial is being run in conjunction with three academic research organisations, including Duke University’s Duke Clinical Research Institute. The other two are Cleveland Clinic and New York-based Mount Sinai Hospital.
