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
OpenTimestamps: ANAB-JEMPERLIDOST-2026.txt.ots, submitted 2026-10-06 21:17 ET. A proof that this hash existed by then, anchored in Bitcoin and checkable with the standard ots verify client beside the hashed text, without relying on us or on X.
Wayback Machine: snapshot of this page, 2026-10-05 22:24 ET

Notes added after the seal

The hashed text above is unchanged and is scored as written. These notes say what we learned about it afterwards.

2026-10-05 23:49 ET — Two facts about this bar that a reader should weigh before the event. First, the BAR line passes only if AZUR-1 reports a clinical complete-response rate of 100%. Its benchmark is the earlier dostarlimab result of 100% in 49 rectal-cancer patients; AZUR-1 enrolled 154. Any rate below 100% scores THIN against this bar, however strong it is clinically. The organ-preservation line uses an 80% figure pooled across 103 patients with rectal, bladder and colon tumors, not rectal alone. Second, this is a bar for an FDA decision, and it scores the trial efficacy rather than the approval and label. From Oct 6 2026 we no longer seal bars for FDA decisions (playbook rule 14), because an approval-and-label checklist cannot be sourced from company documents. This bar stays as sealed and will be scored as written.

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.