Moderna Stock Price, News & Analysis

Moderna (NASDAQ:MRNA) has announced positive preliminary immunogenicity data for its 2025-2026 formula of Spikevax®, targeting the LP.8.1 COVID-19 variant. The Phase 4 clinical trial demonstrated an 8-fold increase in neutralizing antibodies against LP.8.1 in high-risk individuals aged 12-64 and all adults over 65.

The vaccine has received FDA approval for individuals 6 months through 64 years with high-risk conditions and all adults 65+. The safety profile remains consistent with previous studies, with no new concerns identified. The vaccine has also secured approvals in multiple international markets including Canada, Europe, Japan, Mexico, and Switzerland.

Moderna (NASDAQ:MRNA) announced the acceptance of five abstracts for presentation at the 2025 International Congress of Inborn Errors of Metabolism (ICIEM) in Kyoto, Japan. The presentations include three oral and two poster presentations covering the company's research on propionic acidemia (PA), methylmalonic acidemia (MMA), and Glycogen Storage Disease Type 1a (GSD1a) programs.

The presentations will feature interim data from Phase 1/2 studies of mRNA-3705 for MMA and mRNA-3745 for GSD1a, marking Moderna's first presentations at a scientific congress for these conditions. Additionally, final results from the mRNA-3927 dose-escalation study for PA treatment will be presented, along with clinical burden data and model-informed dose selection analyses.

Moderna (NASDAQ:MRNA) has received FDA approval for its updated COVID-19 vaccines, Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 for the 2025-2026 season. Spikevax is approved for high-risk individuals aged 6 months to 64 years and all adults over 65, while mNEXSPIKE is approved for high-risk individuals aged 12 to 64 years and all adults over 65.

The vaccines, developed following FDA guidance for monovalent JN.1 lineage targeting, are expected to be available immediately. The approval comes as COVID-19 caused 4 million outpatient visits and nearly 500,000 hospitalizations last year. The vaccines have already received regulatory approval in Canada, Europe, Japan, and Switzerland.

Moderna (NASDAQ:MRNA) has received Health Canada's approval for its updated COVID-19 vaccine Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant. The vaccine is authorized for individuals aged six months and older.

In a significant milestone for Canadian biomanufacturing, all 2025 pre-filled syringe doses will be manufactured domestically. The drug substance will be produced at Moderna's new Laval, Quebec facility, with fill-finish operations at Novocol Pharma in Cambridge, Ontario. The vaccine has already received approvals in Europe, Japan, and Switzerland, with additional regulatory reviews ongoing globally.

Moderna (NASDAQ:MRNA) has announced its participation in two major healthcare investor conferences in September 2025. The company will present at the Morgan Stanley's 23rd Annual Global Healthcare Conference on September 8th at 10:00am ET and at Bernstein Insights: Healthcare Leaders and Disruptors on September 25th at 10:30am ET.

Investors can access live webcasts of both presentations through the "Events and Presentations" section of Moderna's investor website. The webcasts will remain archived on the company's website for a minimum of 30 days after each presentation.

Harbinger Health announced the appointment of Ajit Singh, Ph.D. as its new CEO and CEO-Partner of Flagship Pioneering. Singh, who has served on Harbinger's board since 2024, brings extensive diagnostics industry experience, particularly from his tenure at Siemens and leadership in oncology diagnostics companies.

Current CEO Stephen Hahn, M.D. will transition to CEO Emeritus and Special Advisor while maintaining his position on the Board of Directors. The leadership change comes as Harbinger advances its platform for early cancer detection using blood-based tests that analyze proprietary methylation patterns of cell-free ctDNA.

The company recently presented data showing promising results in detecting multiple high-incidence, high-mortality cancers related to obesity, along with platform innovations to enhance cancer signal detection.

Moderna (NASDAQ:MRNA) reported Q2 2025 financial results with revenues of $142 million, down 41% year-over-year, and a GAAP net loss of $(0.8) billion or $(2.13) per share. The company reduced its 2025 revenue guidance to $1.5-$2.2 billion, a $300 million reduction at the high end due to delivery timing shifts. Cost optimization efforts led to improved operating expense outlook, reduced by $400 million.

Key developments include three recent FDA approvals for COVID-19 vaccines and positive Phase 3 efficacy results for seasonal influenza vaccine. The company maintains a strong cash position of $7.5 billion and projects year-end cash balance of approximately $6 billion. Moderna also announced a workforce reduction of approximately 10%, targeting under 5,000 employees by year-end.

Moderna (NASDAQ:MRNA) has secured a significant legal victory as the UK Court of Appeal upheld the validity of its EP'949 patent and confirmed that it is infringed by Pfizer/BioNTech's COVID-19 vaccine Comirnaty®. This marks the first global second-instance decision validating one of Moderna's core mRNA patents.

The ruling reinforces the initial High Court decision from July 2024, which Pfizer/BioNTech had appealed. Additionally, Moderna has achieved favorable legal outcomes in other European jurisdictions: Germany's Regional Court found patent infringement by Pfizer/BioNTech, and the European Patent Office (EPO) upheld EP'949's validity in opposition proceedings, though appeals are pending in both cases.

Moderna (NASDAQ:MRNA) has received European Commission (EC) approval for its updated COVID-19 vaccine Spikevax® targeting the SARS-CoV-2 variant LP.8.1. The authorization covers individuals six months of age and older across all 27 EU member states, Iceland, Liechtenstein, and Norway.

The approval follows a Positive Opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) and aligns with global health authorities' recommendations for the 2025-2026 vaccination season. The vaccine has shown a favorable safety profile, with injection site pain being the most common local adverse event.