Moderna, Inc. has released its annual R&D day event, highlighting its progress and strategic priorities. The company announced that it expects to submit its next-generation COVID vaccine for approval in 2024, along with a flu/COVID combination vaccine. It also announced positive phase 3 results for its RSV vaccine for high-risk adults aged 18 to 59 and its standalone flu vaccine for adults aged 65 and older.
The company has implemented portfolio prioritization and cost efficiencies to reduce its R&D expense by $1.1 billion, from $4.8 billion in 2024 to $3.6-3.8 billion in 2027.
Moderna's R&D strategy has shown significant success, with the combined probability of success across its mid* and late-stage pipeline at approximately 66%, compared to the industry average of approximately 19%.
In terms of its product pipeline, the company expects 10 product approvals through 2027. Specifically, in 2021-2023, Moderna invested proceeds from its pandemic-era vaccine sales into building a diverse pipeline. In 2023-2026, the company is establishing a portfolio of five commercial respiratory vaccines. Looking ahead to 2026-2028, Moderna will expand its commercial portfolio with first-in-class vaccines and therapeutics to address non-respiratory diseases.
Updates from Moderna’s late-stage portfolio and approved vaccines include:
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COVID-19: Moderna continues to address the needs of the endemic COVID-19 market and has produced variant-matched vaccines on an accelerated time horizon. Positive results from the nextcove phase 3 trial showed that Moderna’s next-generation COVID-19 vaccine demonstrated non-inferior relative vaccine efficacy compared to spikevax.
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Respiratory Syncytial Virus (RSV): Moderna's RSV vaccine, Mresvia, has been approved for adults aged 60 years and older in the U.S. and EU. The company intends to extend the indicated age range of its RSV vaccine to high-risk adults 18 to 59 years old and intends to use a priority review voucher.
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Influenza (Flu): Moderna has several seasonal influenza vaccine candidates in clinical development. Its investigational seasonal flu vaccine, mRNA-1010, demonstrated consistently acceptable safety and tolerability across three phase 3 trials.
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Combination Respiratory Vaccines: The phase 3 study of Moderna’s investigational combination vaccine against flu and COVID-19, mRNA-1083, met its primary endpoints and elicited higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older.
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Latent and Other Virus Vaccines: Moderna has a pivotal phase 3 trial evaluating mRNA-1647 against primary cytomegalovirus (CMV) infection in women 16 to 40 years of age. Additionally, the company is working on a trivalent norovirus vaccine candidate, mRNA-1403, and plans to initiate a pivotal phase 3 trial imminently.
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Oncology Therapeutics: Moderna’s oncology portfolio includes the individualized neoantigen therapy (INT) being developed in partnership with Merck. The phase 3 clinical trial for adjuvant melanoma, mRNA-4157, is substantially enrolled and has closed screening to new patients in many countries.
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Rare Disease Therapeutics: The company’s rare disease candidates include therapies targeting two organic acidemias caused by deficient metabolic enzymes, methylmalonic acidemia (MMA) and propionic acidemia (PA).
Today the company's shares have moved 0.3% to a price of $79.51. Check out the company's full 8-K submission here.
