Adagio Therapeutics to Submit an EUA Application to the U.S. FDA
Mar 30, 2022 By MarketDepth
Adagio Therapeutics, Inc. (Nasdaq: ADGI) today announced plans to engage with the U.S. Food and Drug Administration (FDA) to submit an Emergency Use Authorization (EUA) application for adintrevimab for both the prevention and treatment of COVID-19.
Shares Surge Over 40%
Shares of Adagio Therapeutics, Inc. (Nasdaq: ADGI) surged over 48% during the premarket trading session following the announcement.
The Company made its decision to engage with the FDA following positive results from its ongoing global Phase 2/3 clinical trials evaluating its investigational drug adintrevimab (ADG20) as a pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19. Across both trials, a single intramuscular (IM) administration of adintrevimab at the 300mg dose had a similar safety profile to that of placebo and primary endpoints were met with statistical significance for all three indications in the studies.
“Based on the data from both EVADE and STAMP, including the impacts observed in preliminary analyses from participants enrolled after the emergence of the Omicron variant, our team is initiating discussions with the FDA and preparing an EUA submission for adintrevimab.”David Hering, MBA, interim Chief Executive Officer and Chief Operating Officer of Adagio
Risk of hospitalization or death in participants with mild to moderate COVID-19 was reduced by 66% compared to placebo in the primary efficacy analysis population and by 77% compared to placebo in participants who received treatment within three days of symptom onset, according to the press release.
“COVID-19 continues to pose significant challenges globally as waning immunity combined with the emergence of resistant variants has led to ongoing waves of disease. We believe that a suite of options – spanning prophylaxis and treatment – is needed to effectively address this virus as it continues to evolve, and these data give us confidence in the potential role adintrevimab can play in physicians’ arsenals.”David Hering, MBA, interim Chief Executive Officer and Chief Operating Officer of Adagio