* Expects agencies to complete re-read by end of the year
* Says doesn't plan to initiate more clinical trials
May 27 Repligen Corp (RGEN.O) said U.S. and
European health regulators have approved its proposal to
re-analyze the images from a late-stage trial of its pancreatic
imaging agent, which had earlier failed to meet its main goal.
Last year, Repligen's said a late-stage study of RG1068 did
not achieve the pre-specified statistical outcome for the
primary goal. [ID:nBNG189747]
The decision to re-read late-stage study was based on the
numerous deficiencies with the analysis of the radiographic
images by the contract research organization hired to oversee
"A successful re-read of the Phase 3 data may support
registration of RG1068 for magnetic resonance imaging of the
pancreas," the company said in a statement.
The company, which does not plan to initiate additional
clinical studies of RG1068 in this indication, said it expects
the agencies to complete the revaluation by the end of the
Shares of the company closed at $3.19 Wednesday on Nasdaq.
(Reporting by Anand Basu in Bangalore; Editing by Aradhana