Submit a BLA for RP1

Not 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: 18 May 2023
Due: 31 Mar 2024
Checked: 1 Oct 2026

Deadline
Met
Late
Not met
Today

What the company said

“assuming positive primary analysis data demonstrating overall clinical benefit, the Company plans to submit a BLA for RP1 in Q1 2024.”

SourceReplimune Group, Inc. Form 8-K press release, 2023-05-18
FilingSEC filing index
Deadline as statedQ1 2024
Deadline used31 Mar 2024, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2023-REPL-002707
Cite as https://keptindex.org/c/KI-C-2023-REPL-002707/ — this address never changes.

What we found

Evidence strength A What the grades mean

The company did not submit the BLA in Q1 2024 as originally planned, subsequently updating its guidance to a submission in the second half of 2024.

A
Replimune Group, Inc. 8-K filed 2024-05-16 Regulatory filing · published 16 May 2024 · retrieved 1 Oct 2026 · kept permanently by the SEC · fingerprint 02345fe18ab9
“The Company completed a successful Type C meeting with the FDA that confirmed alignment on our Chemistry, Manufacturing and Controls (CMC) plans to support our IGNYTE anti-PD1 failed melanoma BLA submission in the 2H 2024.” ✓ confirmed on the page
A
Replimune Group, Inc. 10-K filed 2024-05-16 Regulatory filing · published 16 May 2024 · retrieved 1 Oct 2026 · kept permanently by the SEC · fingerprint 36a226180e11
“we plan to submit a BLA for this cohort in the second half of 2024.” ✓ confirmed on the page

Market reaction: the shares moved -12.8% against the S&P 500 over the three sessions around the disclosure (15 May 2024 to 20 May 2024). 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.

1 versions

Version 1 · original · stated 18 May 2023

Deadline 31 Mar 2024 (“Q1 2024”) · wording expected
Version 2 · stated 5 Dec 2023

Deadline 31 Dec 2024 (“2H 2024”) · wording expected

“biologics license application (BLA) submission planned for 2H 2024”
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 submission for RP1
Language: Expected (“expects”, “plans”)
In the company’s control: Medium
Specificity: High
Conditional: Yes: assuming positive primary analysis data demonstrating overall clinical benefit
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.
Third check on a negative finding: agreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind and reached the same answer.

Confirmed. This outcome counts towards the company's Kept Score. How verification works

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