Submit BLA for RP1 in anti-PD1 failed melanoma

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: 8 Jan 2024
Due: 31 Dec 2024
Delivered: November 2024

Deadline
Met
Late
Not met
Today

What the company said

“BLA filing planned 2H 2024”

SourceReplimune Group, Inc. Form 8-K press release, 2024-01-08
FilingSEC filing index
Deadline as stated2H 2024
Deadline used31 Dec 2024, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2024-REPL-002726
Cite as https://keptindex.org/c/KI-C-2024-REPL-002726/ — this address never changes.

What we found

Evidence strength A What the grades mean

The company submitted the Biologics License Application (BLA) for RP1 in combination with nivolumab to the FDA in November 2024, which falls within the second half of 2024.

A
Replimune Group, Inc. 10-Q filed 2025-02-12 Regulatory filing · published 12 Feb 2025 · retrieved 1 Oct 2026 · kept permanently by the SEC
“In November 2024, we announced submission of a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab” ✓ confirmed on the page

Market reaction: the shares moved +9.0% against the S&P 500 over the three sessions around the disclosure (11 Feb 2025 to 14 Feb 2025). What this measures

Checked 1 Oct 2026.

Commitment lineage

Every time the company restated this commitment. The original is never changed, and the outcome is always measured against version 1.

2 versions

Version 1 · original · stated 8 Jan 2024

Deadline 31 Dec 2024 (“2H 2024”) · wording expected
Version 2 · stated 12 Nov 2024

Deadline 31 Dec 2024 (“before the end of the year”) · wording firm

“remain on track to submit a BLA for RP1 plus nivolumab in anti-PD1 failed melanoma via the accelerated approval pathway before the end of the year”
Source for this version

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: Submit
Deliverable: BLA filing
Language: Expected (“expects”, “plans”)
In the company’s control: High
Specificity: High
Depends on: Regulatory

How this entry was checked

Commitment recordedThe company's words were matched word for word against the filing.
First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
Second check: agreesA different AI model, Claude (Anthropic), 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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