Intarcia’s path uncertain after second regulatory stumble for diabetes implant

Massive fund-raising over the past decade positioned Intarcia to enter the market with ITCA 650, a matchstick-sized implant that delivers a GLP-1R agonist to Type II diabetes patients subcutaneously for six months. But now that the company has received a second complete response letter for the product, it’s still waiting to see whether a meeting with FDA will point the way toward approval.

In a statement provided to BioCentury by spokesperson Sunny Uberoi, Intarcia Therapeutics Inc. said it is looking forward to its conversation with FDA “to make sure we understand the situation and the path forward.”...