Drug Safety And EffectivenessUnforeseen safety or tolerability issues with ARCT-154, ARCT-810, or ARCT-032 and potential failure of these mRNA drugs to be effective in human clinical trials pose significant risks.
Regulatory DelaysThere is a slight delay in timing for ARCT-810 for OTC update and EU Kostaive approval, which were pushed back compared to previous expectations.
Vaccine Market ChallengesCurrent stocks of H5N1 vaccines have largely been found to be a poor match to the circulating strain, indicating challenges in the existing vaccine effectiveness.