Submit a U.S. regulatory application for cemdisiran monotherapy in generalized myasthenia gravis
Deadline passed; outcome being checked
- Announced
- 28 Oct 2025
- Due
- 31 Mar 2026
- Status
- Checking
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“A U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA.”
What we found
The deadline has passed. We check for public evidence starting 30 days after the deadline, and repeat the check if nothing clear turns up.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- U.S. regulatory submission for cemdisiran monotherapy
- Where
- United States
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- Medium
- Specificity
- High
- Conditional
- Yes: pending discussions with the FDA
- Depends on
- Regulatory
Tell me what happens
This deadline has not been settled yet. We check 30 days after it passes. Get an email when we record the outcome.
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- OutcomeNot yet assessed. Nothing is judged before the deadline.
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Report an error in this entry Reference: KI-C-2025-REGN-006354 · Corrections policy