Submit a New Drug Application for mavacamten to the FDA
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
- 5 Oct 2020
- Due
- 31 Mar 2021
- Delivered
- March 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“A New Drug Application (“NDA”) for mavacamten for the treatment of symptomatic obstructive HCM – based on data from the EXPLORER-HCM study – is expected to be submitted to the U.S. Food and Drug Administration”
What we found
Evidence strength A What the grades mean
The company announced in March 2021 that the FDA had accepted its New Drug Application for mavacamten, confirming the submission occurred within the first quarter of 2021.
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A Bristol Myers Squibb Co. 10-Q filed 2021-04-29
“In March 2021, the FDA accepted the NDA for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy.” ✓ confirmed on the page
Market reaction: the shares moved -4.0% against the S&P 500 over the three sessions around the disclosure (28 Apr 2021 to 3 May 2021). 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
- New Drug Application for mavacamten
- 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.
- 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-2020-BMY-003189 · Corrections policy