FDA grants fast track status to Pharmasset’s Hep C drug candidate PSI-938
Earlier on Wednesday, Pharmasset Inc. announced that PSI-938, a drug intended to treat hepatitis C, has been granted fast-track designation by the United States Food and Drug Administration.
The agency’s decision will facilitate a gradual submission of the marketing application by Pharmasset rather than a one-time dossier submission. The FDA will use its discretion to review the application within six months instead of the standard 10 months.
PSI-938 is being studied by Pharmasset as a single treatment intended to treat hepatitis C. The company plans to launch a clinical trial in the third quarter that will evaluate the effect of PSI-938 in combination with its most advanced drug candidate, PSI-977.
In morning trading, Pharmasset shares jumped 97 cents to $126.18.