Oncology

Diagnostics
Genomics

Freenome's updated SimpleScreen CRC test improves APL sensitivity

Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
Diagnostics
Genomics

Cerenome wins Florida Blue coverage for CNSide CSF molecular tests

The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
Medical Devices
Diagnostics
Pharmaceuticals

Profound Medical and Telix link up on PSMA-PET and MRI prostate care

The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
Biologics
Pharmaceuticals

NovaBridge to present givastomig Phase 1b data at ESMO 2026

Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
Pharmaceuticals
Biologics

iOnctura's roginolisib gets dual Nature Communications papers

Two peer-reviewed studies detail roginolisib's novel PI3Kδ binding mode and report a near-threefold OS improvement in metastatic uveal melanoma over historical controls.
Two peer-reviewed studies detail roginolisib's novel PI3Kδ binding mode and report a near-threefold OS improvement in metastatic uveal melanoma over historical controls.
Biologics
Pharmaceuticals
Diagnostics

FDA approves Roche's Tecentriq for adjuvant stage III dMMR colon cancer

Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
Diagnostics
Genomics
Biologics

Myriad Genetics and SOPHiA GENETICS team up on prostate HRD biomarker

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
Biologics
Pharmaceuticals
Cell & Gene Therapy

Cullinan Therapeutics doses first patient in pivotal CLN-049 AML study

The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
Pharmaceuticals
Biologics

ArriVent firmonertinib misses Phase 3 PFS endpoint in NSCLC

The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
Biologics
Pharmaceuticals

Epcoritamab plus R-CHOP cuts DLBCL progression risk by 51% in Phase 3

Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
Cell & Gene Therapy

Ernexa Therapeutics names Spiegel to board ahead of ERNA-101 IND

Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Cell & Gene Therapy
Biologics
Pharmaceuticals

MiNK Therapeutics to show iNKT cell data at SITC 2026

MiNK will present two posters at SITC covering checkpoint-resistant colorectal cancer and senescent tumour-cell clearance using its iNKT platform.
MiNK will present two posters at SITC covering checkpoint-resistant colorectal cancer and senescent tumour-cell clearance using its iNKT platform.
Biologics
Pharmaceuticals

Genmab's Rina-S hits 46% response rate in PROC trial

Phase 2 data show Rina-S achieved a 45.9% objective response rate and 12.1-month median duration of response in heavily pretreated platinum
Phase 2 data show Rina-S achieved a 45.9% objective response rate and 12.1-month median duration of response in heavily pretreated platinum
Biologics
Pharmaceuticals

Leads Biolabs' opamtistomig wins Japan orphan status for EP-NEC

The PD-L1/4-1BB bispecific antibody has now secured orphan drug designation in Japan, the US, and Europe, as its China NDA enters technical
The PD-L1/4-1BB bispecific antibody has now secured orphan drug designation in Japan, the US, and Europe, as its China NDA enters technical
Medical Devices
Diagnostics
Pharmaceuticals

IBA to distribute ARTMS QIS cyclotron technology for theranostics

IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
Pharmaceuticals
Genomics

Cullinan files NDA for zipalertinib in first-line EGFR ex20ins NSCLC

Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
Biologics
Cell & Gene Therapy

ViroMissile clears first cohort in IV-dosed oncolytic virus Phase I

ViroMissile's Safety Review Committee has cleared IDOV-2 to advance to a higher dose cohort, with one patient showing confirmed stable disease at six
ViroMissile's Safety Review Committee has cleared IDOV-2 to advance to a higher dose cohort, with one patient showing confirmed stable disease at six
Pharmaceuticals
Biologics

Roche giredestrant cuts progression risk 44% in breast cancer trial

Phase III evERA data published in NEJM show giredestrant plus everolimus nearly halved disease progression risk in ER-positive advanced breast cancer.
Phase III evERA data published in NEJM show giredestrant plus everolimus nearly halved disease progression risk in ER-positive advanced breast cancer.
Biologics
Pharmaceuticals

Regeneron's ubamatamab hits 73% response rate in LGSOC trial

Phase 1/2 data from 11 heavily pre-treated patients showed a 73% objective response rate and 11-month median progression-free survival.
Phase 1/2 data from 11 heavily pre-treated patients showed a 73% objective response rate and 11-month median progression-free survival.
Pharmaceuticals
Biologics

Highlight Therapeutics: BO-112 meets Phase 2b BCC endpoint

Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
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