Submit NDA for bitopertin in erythropoietic protoporphyria

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: 27 Feb 2025
Due: 31 Dec 2025
Delivered: September 2025

Deadline
Met
Late
Not met
Today

What the company said

“Targeting NDA submission for bitopertin in erythropoietic protoporphyria (EPP) in H2 2025”

SourceDisc Medicine, Inc. Form 8-K press release, 2025-02-27
FilingSEC filing index
Deadline as statedH2 2025
Deadline used31 Dec 2025, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2025-IRON-002190
Cite as https://keptindex.org/c/KI-C-2025-IRON-002190/ — this address never changes.

What we found

Evidence strength A What the grades mean

The company submitted the New Drug Application (NDA) for bitopertin in erythropoietic protoporphyria in September 2025, which is within the second half of 2025.

A
Disc Medicine, Inc. 10-K filed 2026-02-26 Regulatory filing · published 26 Feb 2026 · retrieved 1 Oct 2026 · kept permanently by the SEC
“in September 2025 we submitted a New Drug Application, or NDA, for accelerated approval of bitopertin in EPP and XLP in the United States” ✓ confirmed on the page

Market reaction: the shares moved +0.4% against the S&P 500 over the three sessions around the disclosure (25 Feb 2026 to 2 Mar 2026). 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 27 Feb 2025

Deadline 31 Dec 2025 (“H2 2025”) · wording aspirational
Version 2 · stated 7 Aug 2025

Deadline 31 Oct 2025 (“in October 2025”) · wording expected

“Expect to submit an NDA in October 2025 under the FDA’s accelerated approval pathway based on Disc’s existing data package”
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: NDA submission for bitopertin
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, 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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