EXCLUSIVE: Vivani Medical's Type 2 Diabetes Treatment NPM-119 Subdermal Implant's IND Gains FDA Clearance For Clinical Use (UPDATED)
Portfolio Pulse from Akanksha Bakshi
Vivani Medical, Inc. (NASDAQ:VANI) announced that the FDA has cleared its Investigational New Drug Application for NPM-119, allowing the commencement of the LIBERATE-1 Phase 1 trial. This trial will evaluate the safety, tolerability, and pharmacokinetics of Vivani’s six-month GLP-1 implant for type 2 diabetes. The study is set to start in the second half of the year. Vivani is also developing other drug implants targeting chronic weight management.
June 13, 2024 | 11:01 am
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Vivani Medical received FDA clearance for its NPM-119 subdermal implant, allowing the start of the LIBERATE-1 Phase 1 trial. This marks a significant milestone as the company transitions to a clinical-stage entity.
The FDA clearance for NPM-119 is a significant milestone for Vivani Medical, marking its transition to a clinical-stage company. This development is likely to positively impact the stock price in the short term as it opens the door for clinical trials and potential future revenue streams.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100