Submit NDA for bitopertin under accelerated approval pathway
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
- 21 Jan 2025
- Due
- 31 Dec 2025
- Delivered
- September 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Planning to submit NDA under accelerated approval pathway in H2 2025 based on existing clinical data”
What we found
Evidence strength A What the grades mean
The company submitted the New Drug Application (NDA) for bitopertin under the accelerated approval pathway in September 2025, which is within the second half of 2025.
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A Disc Medicine, Inc. 10-K filed 2026-02-26
“in September 2025 we submitted a New Drug Application, or NDA, for accelerated approval of bitopertin in EPP and XLP in the United States based on our existing data.” ✓ 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 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 for bitopertin
- In the company’s control
- High
- Specificity
- High
- Conditional
- Yes: accelerated approval pathway
- 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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Report an error in this entry Reference: KI-C-2025-IRON-002188 · Corrections policy