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RGDO |
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Regado Biosciences is an IPO from last fall that came out of research at Duke University. Their product (REG-1) is currently in Phase III testing with planned results from this trial being available in 2015. The planned enrollment calls for approximately 13,000 patients needing intervention for Percutaneous Coronary Intervention (PCI). The total market for antithrombotic procedures is well into the multi-billion dollar range based on the worldwide needs.
The REG-1 drug consists of an aptamer-based anticoagulant and its matching antidote. The REG-1 anticoagulant component (RB006) is a single-stranded, nucleic acid aptamer. The other component in the drug is (RB007) and works as the antidote that causes the predictable reversal of (RB006), resulting in the patient’s blood returning to normal. There are various drugs currently on the market; the advantage of the REG-1 drug is the dual action of turning ON and OFF the blood flow during the various vascular procedures that relate to thrombotic issues that occur in growing numbers.
YTD, the stock has been on a virtual rocket ride as it has risen about 150%. Several events have instigated this movement:
1) February 5th-Robert Kierlan made a direct purchase of 400,000 shares @$5.00. This now gives him a 10.81% holding based on 3,700,000 shares. Mr. Kierlan is one with a Midas Touch with his investment acumen.
2) February 13th- Expanded their drug platform into another indication where they filed and IND for REG-2. This application was accepted by the FDA.
3) March 10th-Regado announced that the FDA had given them Fast-Track Designation for REG-1.
Today (April 3rd,2014) is the ‘good news’ ‘bad news’ day for the stock as it currently is down about 10%.
First the good news! Last night RGDO announced, based on the first 1,000 patients that had been enrolled, the interim review data gave them the go-ahead for enrolling ‘all comers’ for PCI events. The fact they have enrolled 1,000 trial patients in only 6 months is surely what can be identified as rapid enrollment, they now have a wider group of patients that will be eligible due to enzyme markers that now apply to all patients. The bad news, RGDO is taking advantage of this clear indicator that the interim review and approval to expand the eligibility for potentials patients has lowered the bar for getting FDA approval. Regado announced a $69 million dollar secondary offering of their stock, and this has placed downward pressure on the stock. However, this secondary was expected and they had already announced that current funding would only take them through the next interim review for safety and efficacy later this year.
IMO—the current data, support of major medical institutions getting such rapid enrollment, experienced management and medical expertise, and now funding that will support the goal of enrolling 13,000 patients by next year-bodes well for the potential of Regado shareholders.
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