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.
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