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High materiality8/10

Agomab Reports Positive 60-Week FSCD Data, Initiates NOV-ERA Phase 2b

Oct 1, 2026, 6:53 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Strong safety/efficacy signals in long-term OLE; initiation of NOV-ERA Phase 2b and expanded patient enrollment represent meaningful clinical and valuation catalysts for AGMB in the near term.

AI summary

What happened, with direct paths to the underlying reporting

Agomab reported favorable 60-week OLE safety data for ontunisertib in Fibrostenosing Crohn’s Disease, with sustained disease control and radiologic stabilization. The trial shows a 3% FSCD-related event rate and near-total CDAI remission by Week 48, supporting a global NOV-ERA Phase 2b initiation with three dose arms and up to 320 patients, potentially advancing the pipeline this year.

STENOVA OLE shows favorable safety through 60 weeks. Disease control sustained.
Annual FSCD event rate is 3%. Only one EBD, no surgeries.
Radiological stricture stabilization observed. MRE data supports trend.
NOV-ERA Phase 2b planned. Initiation expected in coming months.
OLE: 49 participants rolled over (94% of eligible) into Part B; plan to evaluate long-term safety and PK.

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