Summit Therapeutics (SMMT) FDA catalyst dates

FreeBioList tracks 1 upcoming catalyst for Summit Therapeutics (SMMT, listed on Nasdaq). It concerns Ivonescimab (EGFR-mutated non-squamous NSCLC after a third-generation EGFR TKI).

First on the list: the PDUFA date for Ivonescimab (EGFR-mutated non-squamous NSCLC after a third-generation EGFR TKI), dated 14 Nov 2026.

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 07 Oct 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Summit Therapeutics SMMT · Nasdaq	Ivonescimab	EGFR-mutated non-squamous NSCLC after a third-generation EGFR TKI	14 Nov 2026 in 37d	PDUFA date	Verified	8-K exhibit 99.1 ↗	Yes
Notes — Filing states the BLA "was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026." Source: 8-K exhibit 99.1, filed 29 Sep 2026 · verified 07 Oct 2026

Companies working on related conditions

Eikon Therapeutics (EIKN)Non-squamous NSCLC (TLR7/8 agonist); Melanoma — first interim analysis; Advanced solid tumours (PARP1-selective); Advanced solid tumours (WRN helicase inhibitor
ArriVent BioPharma (AVBP)First-line EGFR exon 20 insertion NSCLC
Cullinan Therapeutics (CGEM)EGFR exon 20 insertion NSCLC, second line
Whitehawk Therapeutics (WHWK)EGFR wild-type NSCLC, platinum-resistant ovarian and endometrial cancer; Advanced ovarian and endometrial cancers
CervoMed (CRVO)Recovery after stroke; Non-fluent variant primary progressive aphasia (biomarker data); Non-fluent variant primary progressive aphasia
Compass Therapeutics (CMPX)Biliary tract cancer (DLL4 x VEGF-A bispecific); TNBC, NSCLC and Hodgkin lymphoma post-checkpoint (PD-1 x PD-L1); Solid tumours (PD-1 x VEGF-A bispecific)

Also due in Q4 2026

Capricor Therapeutics (CAPR)PDUFA date (extended) for Deramiocel, 22 Nov 2026
Merck & Co. (MRK)PDUFA date for Ifinatamab deruxtecan (I-DXd), 10 Oct 2026
Cytokinetics (CYTK)PDUFA date for Aficamten, 14 Nov 2026
BridgeBio Pharma (BBIO)PDUFA date for BBP-418, 27 Nov 2026
Zai Lab Ltd. (ZLAB)PDUFA date for Povetacicept, 30 Nov 2026
PolyPid Ltd. (PYPD)PDUFA date for D-PLEX100, 28 Nov 2026