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Moderna News: FDA Approvals, R&D, & Financial Updates

By: Jasmin Espinas
June 2, 2025

Moderna is currently one of the most closely watched names in the pharmaceutical and biotech sectors, primarily driven by its mRNA technology pipeline and vaccine development. In recent Moderna news, the U.S. Food and Drug Administration (FDA) has approved Moderna’s new COVID-19 vaccine.

This article also covers the recent cancellation of its bird flu vaccine deal, Q1 2025 earnings results, long-term growth targets through 2027, and its upcoming conference participation.

Latest Moderna News: FDA Approves Moderna’s Next-Generation COVID Vaccine

Moderna announced on May 31 that the U.S. FDA has approved mNEXSPIKE® (mRNA-1283).

We announced today that the U.S. FDA has approved mNEXSPIKE®, a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes… pic.twitter.com/RJ1CezICKZ

— Moderna (@moderna_tx) May 31, 2025

This updated COVID-19 vaccine is for adults 65 and older and individuals aged 12 to 64 with at least one underlying condition as defined by the CDC. It is Moderna’s third FDA-approved product.

According to CEO Stéphane Bancel, the approval provides an additional option for protecting high-risk groups from severe COVID-19.

Last year alone, over 47,000 deaths in the U.S. were attributed to the virus, underscoring the need for continued access to preventive tools.

In Phase 3 trials, mRNA-1283 demonstrated a comparable safety profile to the original mRNA-1273, with fewer local reactions and similar systemic effects.

The most common side effects reported included pain at the injection site, fatigue, headache, and muscle aches.

Moderna also plans to distribute mNEXSPIKE during the 2025–2026 respiratory season, alongside its other vaccines, Spikevax and mRESVIA®.

Regulatory reviews for mRNA-1283 are ongoing in several international markets.

Following this Moderna news, the company’s shares rose on June 2, signifying a strong investor response.

Moderna News: U.S. Government Cancels $700 Million Bird Flu Vaccine Deal

On May 28, Moderna confirmed that the U.S. government canceled its contract for the development and potential purchase of a bird flu vaccine intended for human use.

The agreement, backed initially under the Biden administration, included $590 million to support late-stage trials and prepare for multiple pandemic influenza strains.

This funding followed a separate $176 million grant from the Department of Health and Human Services (HHS) in 2024. The goal was to finalize research on an mRNA-based vaccine targeting H5N1, a strain with pandemic potential.

Earlier this year, HHS told Reuters it was reviewing vaccine development agreements approved under the previous administration.

The cancellation now interrupts what had been a multi-phase funding strategy across agencies.

In response to this Moderna news, infectious disease experts have raised concerns about the decision.

Amesh Adalja of the Johns Hopkins Center for Health Security called it a setback, warning that the cancellation removes a potentially fast and effective tool for managing future outbreaks.

Moderna News: Q1 2025 Results Show Smaller-Than-Expected Loss and Revenue Decline

In another Moderna news, the company released its Q1 2025 results on May 1, reporting $108 million in total revenue, down from $167 million in the same quarter last year.

This drop reflects reduced product sales, which totaled $86 million, as COVID vaccine demand continues to shift toward a seasonal schedule.

The company also expects most of its respiratory-related revenue to come in the second half of the year.

Cost of sales for the quarter reached $90 million, including $42 million in inventory write-downs and $21 million tied to unused manufacturing capacity.

Although total costs declined by $6 million year-over-year, they still represented 104% of net product sales, up from 58% in Q1 2024, due to the lower sales base.

Moderna also reported a 19% drop in R&D spending, totaling $856 million.

This reduction links to lower clinical activity across respiratory programs and the wind-down of several trials. However, these adjustments align with its broader cost management strategy.

Moderna reaffirmed its full-year revenue outlook of $1.5 to $2.5 billion. It expects to generate around $200 million in the first half of 2025 and maintain projected spending across R&D, administrative functions, and capital investments.

At the same time, cash and investments are projected to remain stable at $6 billion by year-end.

Additionally, Moderna outlined updated targets to reduce its operating costs.

The company now expects GAAP operating expenses to fall to $5.4–$5.7 billion in 2026 and between $4.7–$5.0 billion by 2027.

Moderna Targets 10 New Product Approvals by 2027

In a January 6 shareholder letter, Moderna CEO Stéphane Bancel outlined plans to secure up to 10 product approvals by 2027.

These include potential launches in oncology, rare diseases, and novel non-respiratory vaccines. The company intends to fund this expansion internally, without seeking outside capital.

Bancel acknowledged the need to convert research output into commercial performance.

He noted that Moderna will not move additional vaccines or rare disease programs into pivotal trials until it demonstrates readiness to support global launches through its own channels or strategic partnerships.

Moderna to Present at Goldman Sachs and Jefferies Conferences

Moderna confirmed on May 27 that it will participate in two upcoming investor conferences.

The company is scheduled to present at the Jefferies Global Healthcare Conference on June 5 at 10:30 a.m. ET, followed by the Goldman Sachs 46th Annual Global Healthcare Conference on June 11 at 8:40 a.m. ET.

Both sessions will be webcast live through the “Events and Presentations” section of the Investors page on modernatx.com. Replays will remain accessible for at least 30 days after each event.

These appearances offer analysts and investors additional context around recent announcements, plans, and broader financial strategy.

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Final Thoughts

Moderna is recalibrating its strategy while advancing targeted programs across infectious disease, oncology, and rare conditions.

Recent decisions point to a shift from expansion to measured delivery, but they will depend on clinical results, regulatory progress, and commercial readiness.

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