File supplemental BLA for RSV vaccine mRNA-1345 in high-risk adults aged 18-59
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 12 Sep 2024
- Due
- 31 Dec 2024
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The Company intends to file a supplemental Biologics License Application (sBLA) for U.S. approval in 2024 to extend the indicated age range”
What we found
Evidence strength A What the grades mean
The 10-K filed 2025-02-21 states the sBLA was filed in December 2024, within the 2024 deadline, though no specific day is given.
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A Moderna 10-K filed 2025-02-21
“We filed a supplemental Biologics License Application (sBLA) for U.S. approval in December 2024 to extend the indicated age range of mRNA-1345 to high-risk adults 18 to 59 years old using a priority review voucher” ✓ confirmed on the page
Market reaction: the shares moved +1.3% against the S&P 500 over the three sessions around the disclosure (20 Feb 2025 to 25 Feb 2025). What this measures
Checked 10 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- File
- Deliverable
- sBLA for mRESVIA in high-risk adults 18 to 59
- Where
- United States
- Language
- Aspirational (“aims”, “intends”)
- In the company’s control
- High
- Specificity
- High
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Gemini (Google), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2024-MRNA-006227 · Corrections policy