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UPDATE 1-FDA, EMA to re-analyze Repligen's late-stage data
May 27, 2010 / 10:45 AM / 7 years ago

UPDATE 1-FDA, EMA to re-analyze Repligen's late-stage data

* Expects agencies to complete re-read by end of the year

* Says doesn’t plan to initiate more clinical trials

May 27 (Reuters) - 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 analysis.

“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 year.

Shares of the company closed at $3.19 Wednesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Aradhana Aravindan)

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