First Wave BioPharma Jumps 25% On Update Of Adrulipase IND Filing

(RTTNews) - Shares of nano-cap company First Wave BioPharma, Inc. (FWBI) jumped about 25% in extended session on Friday after the company provided update on IND filing for phase 2 trial of enhanced microgranule formulation of Adrulipase for exocrine pancreatic insufficiency.

The clinical-stage biopharmaceutical company said that the U.S. Food and Drug Administration (FDA) is reviewing the Investigational New Drug (IND) amendment for the planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) as an IND protocol amendment.

Under FDA's policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources.