Form 8-K · Current report

Moderna 8-K, filed Nov 6, 2026

Filed
CIK
0001682852
Accession no.
0001682852-26-000194
AI-generated summary

Summary

Moderna reported third-quarter 2026 revenue of $1.3 billion, up 29% year over year, with GAAP net income of $162 million and diluted EPS of $0.38, and raised its full-year 2026 revenue growth outlook to 15%–25% from up to 10%. The company also reported positive Phase 3 results for intismeran autogene with Merck in resected high-risk melanoma, U.S. FDA approval of its seasonal influenza vaccine mFLUSIVA, and an agreement with GSK to settle all pending U.S. and European disputes through patent cross-licenses.

Key points

  • Moderna raised its 2026 revenue growth outlook to 15%–25% from up to 10%, improved its 2026 operating expense outlook by about $0.2 billion, and increased expected year-end cash and investments to $8.1–$8.3 billion.
  • In the INTerpath-001 Phase 3 study, intismeran autogene plus KEYTRUDA reduced the risk of recurrence or death by 42% (HR=0.58) versus KEYTRUDA alone in resected high-risk melanoma, with a 58% reduction after six months in a pre-specified sensitivity analysis.
  • The FDA approved mFLUSIVA for adults aged 50–64 and granted accelerated approval for those 65 and older, Moderna's fifth approved product globally, with a limited U.S. launch for the 2026–2027 influenza season.
  • Moderna and GSK agreed on October 28, 2026 to settle all disputes pending in the U.S. and Europe, granting patent cross-licenses in infectious disease with no payments of any kind.

Written by an AI model from the filing text. It can be incomplete or wrong; the filing on SEC.gov is the record.

Items reported

  • 2.02Results of Operations and Financial Condition
  • 9.01Financial Statements and Exhibits

From the filing

Item 2.02 Results of Operations and Financial Condition. On November 6, 2026, Moderna, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference. The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933…

An excerpt of the text as filed with the SEC, cut for length.

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