Thursday, March 01, 2012 2:50:59 PM
RGEN..$4.55 Many Upcoming Expected Milestones in 2012. Market cap of only 140m Will be a busy year for them & should continue to be a good year for the stock. Bolded the two most crucial milestones.
Near-Term Milestones
- 1Q 2012 – Submit SecreFlo™ Marketing Authorization Application in Europe
- 1Q 2012 – Enroll first patient in RG2833 Friedreich’s ataxia Phase I study in Italy
- 2Q 2012 – Interim data on SecreFlo™ pilot study to improve diagnosis of pancreatic cancer
- 2Q 2012 – Complete integration of Novozymes Biopharma AB
- 2Q 2012 – Report results of RG3039 Phase I study for Spinal Muscular Atrophy
- 2Q 2012 – Present SecreFlo™ Phase III data at Digestive Disease Week (DDW)
- June 21, 2012 – SecreFlo™ PDUFA date with priority review
- 2H 2012 – Launch SecreFlo™ in the US pending FDA approval
- 2H 2012 – Initiate pediatric studies of SecreFlo™
Company has zero debt & 50m in cash. $1.62 cash per share & $2.21 book value per share. Only 30m shares outstanding and only 40m authorized. Little chance of dilution and if so it can only be to 40m unless authorized by board of directors to increase the authorized. Only 26m shares in the float. Almost 40% held by institutions. 3m avg volume of only 35,000 shares. This should get more attention in the coming months.
Clinical Basis for SecreFlo™ NDA
The SecreFlo™ NDA was submitted to the FDA based on positive outcomes from the re-read of the Company’s Phase 3 clinical study. This pivotal study was a multi-center, baseline controlled, single dose study in which 258 patients were enrolled at 23 clinical sites in the U.S. and Canada. Each patient
in the study received an MRI of the pancreas with and without SecreFlo™, and separately underwent endoscopy (ERCP) as a diagnostic reference. The MRI images were randomized and independentlyread and reviewed by three central radiologists.
The Phase 3 study re-read demonstrated that all endpoints were met with statistical significance, and that SecreFlo™ was safe and well tolerated. The study’s co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities of the pancreatic ducts
with minimal loss in specificity by two of the three central radiologists reading the MRI images. The study met its primary endpoints, demonstrating that the addition of SecreFlo™ to MRI resulted in a highly statistically significant improvement (p<0.0001) in sensitivity of detection of ten prespecified
abnormalities of the pancreatic ducts, with minimal loss in specificity (<7.5%). All three secondary endpoints were also met, with each demonstrating highly statistically significant improvements (p<0.0001) in image quality, visualization of the main pancreatic duct and diagnostic confidence when compared to MRI alone. A radiologist’s ability to more confidently identify and characterize pancreatic duct abnormalities has the potential to substantially improve “next-step” clinical decisions
(patient triage) and patient outcomes. SecreFlo™ was previously granted Fast Track designation by the FDA and also has Orphan Drug
status, which qualifies Repligen to receive seven years of U.S. marketing exclusivity for SecreFlo™, if approved. In addition to it’s U.S. application for approval of SecreFlo™, the Company plans to file a marketing authorization application (MAA) during the first quarter of 2012 for potential approval of SecreFlo™ in the EU.
Near-Term Milestones
- 1Q 2012 – Submit SecreFlo™ Marketing Authorization Application in Europe
- 1Q 2012 – Enroll first patient in RG2833 Friedreich’s ataxia Phase I study in Italy
- 2Q 2012 – Interim data on SecreFlo™ pilot study to improve diagnosis of pancreatic cancer
- 2Q 2012 – Complete integration of Novozymes Biopharma AB
- 2Q 2012 – Report results of RG3039 Phase I study for Spinal Muscular Atrophy
- 2Q 2012 – Present SecreFlo™ Phase III data at Digestive Disease Week (DDW)
- June 21, 2012 – SecreFlo™ PDUFA date with priority review
- 2H 2012 – Launch SecreFlo™ in the US pending FDA approval
- 2H 2012 – Initiate pediatric studies of SecreFlo™
Company has zero debt & 50m in cash. $1.62 cash per share & $2.21 book value per share. Only 30m shares outstanding and only 40m authorized. Little chance of dilution and if so it can only be to 40m unless authorized by board of directors to increase the authorized. Only 26m shares in the float. Almost 40% held by institutions. 3m avg volume of only 35,000 shares. This should get more attention in the coming months.
Clinical Basis for SecreFlo™ NDA
The SecreFlo™ NDA was submitted to the FDA based on positive outcomes from the re-read of the Company’s Phase 3 clinical study. This pivotal study was a multi-center, baseline controlled, single dose study in which 258 patients were enrolled at 23 clinical sites in the U.S. and Canada. Each patient
in the study received an MRI of the pancreas with and without SecreFlo™, and separately underwent endoscopy (ERCP) as a diagnostic reference. The MRI images were randomized and independentlyread and reviewed by three central radiologists.
The Phase 3 study re-read demonstrated that all endpoints were met with statistical significance, and that SecreFlo™ was safe and well tolerated. The study’s co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities of the pancreatic ducts
with minimal loss in specificity by two of the three central radiologists reading the MRI images. The study met its primary endpoints, demonstrating that the addition of SecreFlo™ to MRI resulted in a highly statistically significant improvement (p<0.0001) in sensitivity of detection of ten prespecified
abnormalities of the pancreatic ducts, with minimal loss in specificity (<7.5%). All three secondary endpoints were also met, with each demonstrating highly statistically significant improvements (p<0.0001) in image quality, visualization of the main pancreatic duct and diagnostic confidence when compared to MRI alone. A radiologist’s ability to more confidently identify and characterize pancreatic duct abnormalities has the potential to substantially improve “next-step” clinical decisions
(patient triage) and patient outcomes. SecreFlo™ was previously granted Fast Track designation by the FDA and also has Orphan Drug
status, which qualifies Repligen to receive seven years of U.S. marketing exclusivity for SecreFlo™, if approved. In addition to it’s U.S. application for approval of SecreFlo™, the Company plans to file a marketing authorization application (MAA) during the first quarter of 2012 for potential approval of SecreFlo™ in the EU.
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