Shares of Regado Biosciences (RGDO) fell 50% after the company reported an unplanned review of the ongoing REGULATE-PCI phase 3 trial of its novel anti-coagulant, Revolixys (previously REG1). The analysis is a result of allergic reactions in the study. But Regado has another worrisome issue: need for more capital next year.
Patient enrollment has been stopped until the DSMB completes an analysis of the current data – the company expects a recommendation in the next eight weeks. The DSMB will analyze the safety and treatment benefit-risk ratio for the 3,234 patients enrolled to date. Regado will remain blinded to study results during the evaluation.
REGULATE-PCI is designed to determine the efficacy of REG1 compared to bivalirudin (Angiomax) in preventing stroke, ischemic events complication, and major bleeding during coronary interventions. The study is slated to enroll 13,200 patients.
The biggest issue for Regado – funding. Regado is going it alone on a huge, expensive study that’s still years from completion. The company ended the first quarter with $34.8 million in cash before raising about $60 million in an April financing. Regado believes this is sufficient to fund the trial and operations through Q1 2015, just nine months.
As a rule of thumb, we consider “less than a year of cash” a red flag when evaluating development-stage biotech companies.
Tekmira Pharmaceuticals (TKMR) reported its own safety issues Thursday morning, and the stock is off 18% as a result. However, we see reason to be optimistic. Read why here.
