FDA lifts clinical hold on Vivani Medical's NPM-119, clears IND for Phase 1 trial

Vivani Medical, Inc.

FDA cleared IND and lifted clinical hold for NPM-119 (exenatide), a six-month GLP-1 implant for type 2 diabetes.
LIBERATE-1 Phase 1 trial will assess safety, tolerability, and pharmacokinetics vs. Bydureon BCise; enrollment expected H2 2024.
First clinical application of NanoPortal implant technology; addresses medication non-adherence affecting ~50% of type 2 diabetes patients.
Lead program NPM-115 (high-dose exenatide) for chronic weight management showed preclinical weight loss comparable to semaglutide.
NPM-139 (semaglutide implant) in pipeline with potential once-yearly dosing.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.