FDA guides on development plans for Immuron’s new oral therapeutic

Immuron (NASDAQ:IMRN) surges 89% premarket after the Naval Medical Research Center (NMRC) received written FDA guidance in relation to the clinical development pathway of the company’s new investigational drug being developed for the treatment of moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli infections.

The Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls, including the proposed release testing specifications of the product as well as the planned clinical studies evaluating the safety and efficacy.

The company expects to conduct two human phase II clinical trials in 2021.

On June 19, Immuron provided an update on the collaboration with NMRC.

https://seekingalpha.com/news/3592500-fda-guides-on-development-plans-for-immurons-new-oral-therapeutic-for-gut-mediated-pathogens