- Adagio Therapeutics Inc (NASDAQ: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.
