RGDO : NASDAQ : US$4.60
Regado Biosciences discovers and develops two-component drug systems using a therapeutic aptamer and its specific active control agent. REG1, the company’s lead product candidate, is an actively controllable anticoagulant that is indicated for use in patients with a wide variety of acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).
All amounts in US$ unless otherwise noted.
INITIATING WITH A BUY, $14 TARGET
Initiating coverage of Regado with a BUY rating, $14 target. We see REG1 as a highly innovative new anticoagulant that could improve outcomes across a large number of CV procedures, starting with NSTEMI PCI.
We think Regado’s imminent Phase 3 REGULATE trial will yield top-line success in late 2015, showing REG1 to have a drug profile superior to that of comparator Angiomax. We also think REGULATE interim safety looks, the first expected in Q1/14, will be positive. We estimate peak REG1 worldwide sales of $2.5B, and our $14 target is based on a pNPV analysis of the drug’s worldwide potential.
Paradigm shift in anticoagulation: REG1 can dial up anticoagulation activities, and then adjust downward as needed. Current procedural anticoagulant options like heparin and Angiomax are not reversible and do not provide MDs with an ideal safety/efficacy profile. REG1, as a two-part system consisting of the aptamer Factor IX inhibitor pegnivacogin and its reversal agent anivamersen, may be a significantly more controllable anticoagulation system.
We think the REGULATE trial will be successful in proving REG1 superior to Angiomax on efficacy, at least equal in safety. RGDO’s Phase 3 REGULATE-PCI trial, due to start within weeks, is designed to show a 20% superiority of REG1 to Angiomax on ischemia (efficacy) and non-inferiority on bleeding (safety). We think chances of success are high based on Phase 2 RADAR data that suggests REG1 has 60% lower rates of ischemia than heparin, which itself has equal/slightly less ischemia than Angiomax. RADAR also showed REG1 to have 66% lower bleed rates versus heparin. Angiomax is thought to have 30-50% lower bleed rates than Angiomax.
REG1 may have significant potential in STEMI-PCI, OHS and TAVR: We think there is significant scientific and clinical rationale and early clinical data to show REG1 potential in these markets.