Repligen imaging agent fails Phase III primary endpoint

A late-stage trial of Repligen's RG1068--a pancreatic imaging agent--missed its primary endpoint, pushing the company's stock down 15 percent this morning. In spite of the results, the developer maintained that the failed trial offered new evidence of the agent's benefits for MRI imaging.

The study's co-primary endpoints were improvements in sensitivity of detection of structural abnormalities of the pancreatic ducts using RG1068 in combination with MRI compared with MRI alone with minimal loss in specificity. "The RG1068-enhanced MRI images showed highly statistically significant improvements on other endpoints for all radiologists including improvements in image quality," the company says in a statement.

"Although this study did not achieve the pre-specified statistical outcome for the primary endpoint, it provides further evidence of the benefits of RG1068 in MRI imaging of the pancreas," said CEO Walter Herlihy. "Further development plans for RG1068 will be determined following discussion of these results with the FDA next quarter."

FDA has granted RG1068 orphan drug status and fast-track designation.

- check out Repligen's release
- here's the piece from Reuters