FDA decision

$ANAB — Jemperli (dostarlimab)

ANAPTYSBIO, INC (ANAB) Jemperli (dostarlimab): FDA decision in Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer, 2027.

Research by Catalyst Intel · Published 2026-10-04 22:05 ET

The catalyst

"The FDA has assigned a PDUFA action date of February 2027"

— AnaptysBio, 8-K filed 2026-09-21 · the filing. Checked word for word against the stored document when this page was built; a sentence that did not check out would not be here.

Event id: ANAB-JEMPERLIDOST-2026
Company: ANAPTYSBIO, INC
Kind: FDA decision
Indication: Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Window: 2027-02-01 – 2027-02-28
Status: bar_published

The bar

Published 2026-10-04 22:05 ET, before the event. The text below is the hashed text: paste it into the verify page and your browser will recompute the same digest.

At a glance

Pass if: Floor: the AZUR-1 disclosure must establish clinical complete-response durability at 12 months… · Bar: the AZUR-1 clinical complete-response rate should be at least as good as the prior dostarl…

Great if (any one): Organ preservation should at least match the prior dostarlimab benchmark [“Recent data publishe…

5 items we could not source — full detail below

EVENT ANAB-JEMPERLIDOST-2026
SCORED SET not stated
FLOOR floor_cCR_durability Floor: the AZUR-1 disclosure must establish clinical complete-response durability at 12 months ["In July 2026, GSK announced positive interim results from the trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months (cCR12) with no detectable signs of cancer for at least one year"].
BAR bar_rectal_complete_response Bar: the AZUR-1 clinical complete-response rate should be at least as good as the prior dostarlimab rectal complete-response result, 100% ["Recent data published in The New England Journal of Medicine (NEJM) and presented at American Association for Cancer Research (AACR) demonstrated neoadjuvant treatment with dostarlimab resulted in organ preservation in a high proportion of patients (80% of 103 patients), including 100% (rectal; n=49), 100% (bladder; n=6), and 82% (colon; n=22) complete responses in April 2025"].
DIFF diff_organ_preservation Organ preservation should at least match the prior dostarlimab benchmark ["Recent data published in The New England Journal of Medicine (NEJM) and presented at American Association for Cancer Research (AACR) demonstrated neoadjuvant treatment with dostarlimab resulted in organ preservation in a high proportion of patients (80% of 103 patients), including 100% (rectal; n=49), 100% (bladder; n=6), and 82% (colon; n=22) complete responses in April 2025"].

SHA-256: 008a6a6f3ce55f74a14d914bee95fc5b0f3de6452187d60aee16057cf570f01b
Frozen: yes
Public post: https://x.com/i/web/status/2106928751019806855

Criteria as committed

Floor — all must pass

Id	Field	Test	As written
`floor_cCR_durability`	`clinical complete-response durability`	`>= 12`	Floor: the AZUR-1 disclosure must establish clinical complete-response durability at 12 months [“In July 2026, GSK announced positive interim results from the trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months (cCR12) with no detectable signs of cancer for at least one year”].

Bar — all must pass

Id	Field	Test	As written
`bar_rectal_complete_response`	`clinical complete-response rate`	`>= 100`	Bar: the AZUR-1 clinical complete-response rate should be at least as good as the prior dostarlimab rectal complete-response result, 100% [“Recent data published in The New England Journal of Medicine (NEJM) and presented at American Association for Cancer Research (AACR) demonstrated neoadjuvant treatment with dostarlimab resulted in organ preservation in a high proportion of patients (80% of 103 patients), including 100% (rectal; n=49), 100% (bladder; n=6), and 82% (colon; n=22) complete responses in April 2025”].

Differentiators — one upgrades IN_LINE to BEAT

Id	Field	Test	As written
`diff_organ_preservation`	`organ preservation rate`	`>= 80`	Organ preservation should at least match the prior dostarlimab benchmark [“Recent data published in The New England Journal of Medicine (NEJM) and presented at American Association for Cancer Research (AACR) demonstrated neoadjuvant treatment with dostarlimab resulted in organ preservation in a high proportion of patients (80% of 103 patients), including 100% (rectal; n=49), 100% (bladder; n=6), and 82% (colon; n=22) complete responses in April 2025”].

What we could not source before the event

No packet document states the AZUR-1 analysis population; scored_set is null.
No ClinicalTrials.gov record or registered primary-outcome measure is available in the packet; primary_outcome is null.
No public packet document prints the AZUR-1 response percentage, denominator, confidence interval, p-value, non-inferiority or superiority margin, or numeric safety cutoff.
No randomized comparator-arm data for AZUR-1 are provided.
The options snapshot and comparator file are placeholders, so no implied move, volatility, open-interest, borrow, or external comparator data can be sourced.

Verdicts

No verdict has been published for this event yet.