Gilead Sciences (NASDAQ:GILD)
says it’s aware of positive data emerging from the National Institute
of Allergy and Infectious Diseases’ (“NIAID”) study of the
investigational antiviral remdesivir for the treatment of COVID-19.
“We understand that the trial has met its primary
endpoint and that NIAID will provide detailed information at an upcoming
briefing,” company says.
The NIAID trial aimed to sign up 600-800 patients and give a definitive answer as to whether remdesivir can help treat the virus.
Separately, GILD published results from its phase 3
SIMPLE trial evaluating 5-day and 10-day dosing durations of the
investigational antiviral remdesivir in hospitalized patients with
severe manifestations of COVID-19 disease. Says patients receiving a
10-day treatment course of remdesivir achieved similar improvement in
clinical status compared with those taking a 5-day treatment course.
“Gilead will continue to discuss with regulatory
authorities the growing data set regarding remdesivir as a potential
treatment for COVID-19,” it says.
“Unlike traditional drug development, we are
attempting to evaluate an investigational agent alongside an evolving
global pandemic. Multiple concurrent studies are helping inform whether
remdesivir is a safe and effective treatment for COVID-19 and how to
best utilize the drug… The study demonstrates the potential for some
patients to be treated with a 5-day regimen, which could significantly
expand the number of patients who could be treated with our current
supply of remdesivir. This is particularly important in the setting of a
pandemic, to help hospitals and healthcare workers treat more patients
in urgent need of care.”
Remdesivir is not yet licensed or approved anywhere globally.
Shares are halted. Trading to resume at 9:00. Prior to the halt, shares were flat at $78.82.
The news appeared to lift index futures, which jumped immediately after GILD issued the first pr
Source: Press release I, press release II
https://seekingalpha.com/news/3565991-gilead-remdesivir-trial-for-covidminus-19-meets-primary-target
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