Molecular Partners AG (NASDAQ:MOLN) shares are trading lower by 36.52% at $8.38 after the company and its partner Novartis expects the FDA may require additional clinical data for the Emergency Use Application for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.
Vas Narasimhan, Novartis’ CEO, also noted 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.
Novartis 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.
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According to data from Benzinga Pro, Molecular Partners has a 52-week high of $28.90 and a 52-week low of $7.89.