Molecular Partners, Novartis Note EUA For COVID-19 Therapy May Need Additional Data

Molecular Partners AG MOLN has provided an update regarding the Emergency Use Application (EUA) for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.
The Company says that EUA, in review with the FDA, may require additional clinical data to be authorized.
Vas Narasimhan also noted that the current omicron wave of SARS-Cov-2, and the lower incidents of hospitalization associated with it, have made clinical investigations challenging to execute in this evolving environment.
Related: Molecular Partners, Novartis Submit Emergency Use Authorization Request For Ensovibep For COVID-19.
Molecular Partners is collaborating with Novartis AG NVS, which is engaging with the FDA to align on a potential Phase 3 study design that could provide the additional data the agency is seeking for the EUA or full regulatory approval.
Price Action: MOLN shares are down 35.2% at $9.00, and NVS stock is up 0.16% at $89.10 during the premarket session on Wednesday's last check.