mRNA-1283

- Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.

- Moderna has initiated dosing of mRNA-4106, an innovative cancer therapy candidate, in a Phase 1 clinical trial, marking a significant step in expanding its oncology pipeline beyond vaccines.

- Moderna's combination flu-COVID vaccine faces FDA delay until 2026, as regulators now require Phase 3 flu efficacy data before approval, signaling potentially heightened scrutiny for vaccine developers.

- Moderna reported $3.2 billion in total revenue for fiscal year 2024, with a net loss of $3.6 billion as the company transitions from pandemic to seasonal COVID-19 vaccine market.

- Moderna's mRNA-1403 norovirus vaccine has entered a pivotal Phase 3 trial, evaluating its efficacy, safety, and immunogenicity in adults.