Moderna’s mRNA-based seasonal flu vaccine mRNA-1010 has been submitted to regulators in the U.S., Europe, Canada, and Australia

This therapy is for use in adults aged 50 and older, after a Phase 3 trial showed 26.6% efficacy, adding another prospective near-term approval catalyst that could shape the firm’s regulatory workload and growth profile through 2027 and beyond.

Moderna has submitted its mRNA-based seasonal flu vaccine, mRNA-1010, for regulatory approval in multiple regions, representing a near-term approval catalyst.

Positive Phase 3 results for tafasitamab in combination with other treatments for diffuse large B-cell lymphoma support plans for a supplemental Biologics License Application, potentially influencing the competitive landscape in hematology.

Key information on approval prospects and potential delays/issues

Moderna has submitted its mRNA-based seasonal flu vaccine, mRNA-1010, for regulatory approval in multiple regions, representing a near-term approval catalyst.