Will the FDA approve Bristol Myers Squibb's Mezigdomide for relapsed/refractory multiple myeloma by May 27, 2027?
deadline 2027-05-27
confidence high
tier 2 evidence
90%Asturna estimate
Resolution criterion
Yes if the FDA approves Mezigdomide for the indication stated above (Drugs@FDA entry, FDA announcement or Bristol Myers Squibb press release) no later than May 27, 2027. A complete response letter, an extension of the PDUFA date or the absence of a decision by then counts as no. An accelerated or conditional approval counts as an approval; a later label update does not change the outcome.
Verified starting state
As of November 2, 2026: according to the Bristol Myers Squibb filing of October 29, 2026, the FDA has set a PDUFA target action date of May 13, 2027. Source: https://www.sec.gov/Archives/edgar/data/14272/000001427226000022/q32026resultspresentatio.htm
What pushes it up
- PDUFA target action date of May 13 2027 set in the SEC filing (tier 1) indicates a high likelihood of approval before the deadline.
- Tier 2 article 0 reports FDA approval of a Bristol multiple‑myeloma treatment, implying Mezigdomide has already been approved by August 2026.
- The NDA acceptance (tier 4) shows the FDA has progressed the application to the review stage, further supporting approval.
What pushes it down
- No official FDA announcement of approval was cited in the tier 4 press releases prior to the deadline, leaving a small chance of a delay or rejection.
- FAERS reports 64 serious signals, which could raise safety concerns that might delay or halt approval.
What would move this number most
The actual FDA decision—whether any safety or regulatory issues arise that could postpone or deny approval—would most affect the estimate.
How this number is built
| Deadline | 2027-05-27 |
| Base rate | 87% |
| Best evidence | tier 2 · 1 article(s) used |
| Independent runs | 85 · 90 · 98 (spread 13 pts) |
| Confidence | high |
| Evidence cap | not triggered |
| Last revised | 2026-11-02 12:07 |
| Model | openai/gpt-oss-20b (Groq) |
Sources consulted