Immuron Shares Hit 52-Week High After FDA Removes Clinical Hold
May 08 2023 - 11:34AM
Dow Jones News
By Chris Wack
Immuron Ltd. shares were up 45% to $2.71 after the company said
that the U.S. Naval Medical Research Center has received approval
from the U.S. Food and Drug Administration to proceed with the
clinical evaluation of a new oral therapeutic targeting
Campylobacter and Enterotoxigenic Escherichia coli, developed in
collaboration with Immuron.
The stock hit its 52-week high of $3.39 earlier in the session,
and is now down 5% in the past 12 months.
The biopharmaceutical company said the FDA has removed a
clinical hold on the Investigational New Drug application allowing
the NMRC to proceed with its plans to evaluate the efficacy of the
hyperimmune product to prevent infectious diarrhea caused by
Campylobacter and ETEC which is now active.
The safety and protective efficacy of the product will be tested
using two controlled human infection-model clinical trials, with
one trial focusing on the ability of the hyperimmune product to
protect volunteers against ETEC infections, and the second trial
focusing on moderate to severe campylobacteriosis.
The first clinical study will be conducted at the Johns Hopkins
University Center for Immunization Research Inpatient Unit, and
will include 30 healthy participants, aged 18-50 years.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
May 08, 2023 11:19 ET (15:19 GMT)
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