Moderna Raises 2025 Forecast, Aims For 2026 Vaccine Approvals

WASHINGTON, Jan 13 (Bernama-dpa) -- United States (US) drugmaker Moderna heads into 2026 with stronger finances and a crowded late-stage pipeline after an aggressive cost reset in 2025 and a slate of regulatory and clinical milestones lined up for the next two years, reported German Press Agency (dpa).

The company now expects about US$1.9 billion in 2025 revenue, above the midpoint of its earlier outlook, and has lowered projected general operating expenses by US$200 million to roughly US$5.0 to US$5.2 billion.

It also lifted its projected year-end cash balance to around US$8.1 billion, supported partly by a recent term-loan draw.

Management reiterated plans to deliver up to 10 per cent revenue growth in 2026 while continuing to rein in spending.

GAAP (Generally Accepted Accounting Principles) operating expenses are expected to fall to about US$4.9 billion next year and decline further in 2027, as the company targets cash break-even in 2028.

In its seasonal vaccine portfolio, Moderna said it is aiming for first approvals in 2026 for both its standalone flu vaccine and its combined flu-COVID shot.

Its next-generation COVID vaccine, mNEXSPIKE, has already been cleared in the US, Canada and Australia, with regulatory decisions in Europe, Japan and Taiwan anticipated next year.

The company is also advancing a Phase 3 RSV (Respiratory Syncytial Virus) revaccination study and continuing a late-stage norovirus programme, with an interim analysis planned in 2026.

Outside infectious disease, several oncology and rare-disease programmes are approaching pivotal inflexion points.

Moderna expects long-term data in early 2026 from a mid-stage melanoma trial of its personalised cancer vaccine developed with Merck, followed by possible Phase 3 results later in the year.

Additional readouts are planned for its wholly owned cancer candidate mRNA-4359 and for registrational studies in propionic and methylmalonic acidemia.

On the corporate front, Moderna recently finalised a five-year loan facility of up to US$1.5 billion with Ares Management Credit Funds and secured up to US$54.3 million in funding from CEPI (Coalition for Epidemic Preparedness Innovations) to push its pandemic flu vaccine into a pivotal trial.

The company will outline these developments at the JP Morgan Healthcare Conference on January 12 and is scheduled to release its full-year 2025 results on February 13.

--BERNAMA-dpa