Biopharmaceutical company Repligen Corp. said Wednesday that its development program for use of a synthetic hormone during a procedure to assess pancreatic abnormalities has received a "fast track" designation from the U.S. Food and Drug Administration.
A fast-track designation means the company can submit clinical trial data to the agency as it becomes available, rather than having to wait to submit it all at once.
Repligen is currently conducting a Phase 3 clinical trial to evaluate the use of RG1068 to improve the assessment of pancreatic abnormalities by magnetic resonance imaging. RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in digestion.
The use of MRI can eliminate the need for more risky invasive procedures, the company said.
Repligen said it expects to complete patient enrollment in the clinical trial this year. If successful, Repligen said it could file a new drug application as soon as 2009.
Shares fell 17 cents, or 3.1 percent, to close at $5.40. Shares gained 3 cents to $5.43 in after-hours trading.
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