Submit U.S. and EU regulatory filings for Bardet-Biedl syndrome
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
- 3 Feb 2021
- Due
- 31 Dec 2021
- Delivered
- October 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“U.S. and EU regulatory submissions for BBS planned for 2H2021”
What we found
Evidence strength A What the grades mean
Rhythm Pharmaceuticals submitted the required regulatory filings for Bardet-Biedl syndrome in the U.S. in September 2021 and in the EU in October 2021, both within the second half of 2021.
-
A Rhythm Pharmaceuticals, Inc. 10-K filed 2022-03-01
“In September 2021, we submitted an sNDA to the FDA for setmelanotide for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with BBS or Alström syndrome, and in October 2021, we submitted a Type II variation application to the EMA” ✓ 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 other
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- U.S. and EU regulatory submissions for BBS
- Where
- U.S. and EU
- 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.
- 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
Are you Rhythm Pharmaceuticals, Inc.? You can publish an official statement next to this entry, free. Add a statement.
Is something here wrong or out of date? Companies and readers can ask us to check it. Please bring a link to a public source.
Report an error in this entry Reference: KI-C-2021-RYTM-022972 · Corrections policy