Adagio Pauses FDA Emergency Use Request For Its COVID-19 Therapy

Adagio Therapeutics Inc ADGI provided an update on the anticipated timing for its Emergency Use Authorization (EUA) request for adintrevimab (ADG20) for the prevention and treatment of COVID-19.
Adintrevimab has demonstrated broadly neutralizing activity in vitro against variants of concern, including Alpha, Beta, Delta, Delta Plus, Gamma, and Omicron BA.1.
But, the candidate has markedly reduced neutralization activity in vitro against the Omicron BA.2 variant.
Related: Adagio's COVID-19 Antibody Meets Primary Goals Across Pre & Post-Exposure Prophylaxis, Treatment.
Based on the FDA feedback regarding adintrevimab's lack of neutralizing activity against the BA.2 variant, Adagio will pause to submit a EUA request.
The company is also conducting an ongoing Phase 1 trial evaluating the pharmacokinetics and the safety of higher doses of adintrevimab in healthy volunteers.
Adagio is on track to have more than one million doses of adintrevimab secured in 2022 in preparation for its potential utility as a prophylaxis and treatment option for COVID-19.
Price Action: ADGI shares are down 5.68% at $3.65 during the market session on the last check Thursday.