Submit an NDA to the FDA for relugolix combination tablet for endometriosis treatment
Delivered after the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 11 Feb 2021
- Due
- 30 Jun 2021
- Delivered
- July 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“NDA submission to the FDA for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in the first half of calendar year 2021.”
What we found
Evidence strength A What the grades mean
The company submitted the supplemental New Drug Application for the endometriosis treatment in July 2021, which occurred after the first-half 2021 deadline.
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A Myovant Sciences Ltd. 10-Q filed 2021-07-28
“In July 2021, Myovant Sciences GmbH (“MSG”), one of the Company’s subsidiaries, submitted a supplemental New Drug Application (“sNDA”) to the FDA for once-daily MYFEMBREE for the management of moderate to severe pain associated with endometriosis.” ✓ confirmed on the page
Checked 25 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 submission for endometriosis treatment
- Where
- U.S.
- 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.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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