Oncology

Diagnostics

Zentalis plots DENALI Part 2 readout in 1H 2027 as cash thins

Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.
Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.
The Biotech Times Editorial Team  · 
Biologics

Gyre Therapeutics affirms $100m+ guidance after Cullgen deal closes

Gyre posted Q2 revenue of $29.1m and reaffirmed full-year guidance of up to $111m as its Cullgen acquisition added a protein-degrader pipeline.
Gyre posted Q2 revenue of $29.1m and reaffirmed full-year guidance of up to $111m as its Cullgen acquisition added a protein-degrader pipeline.
The Biotech Times Editorial Team  · 

Amplia signs Lilly deal to test FAK inhibitor in KRAS G12C lung cancer

Amplia Therapeutics will combine narmafotinib with Lilly's olomorasib in a Phase 1b/2b NSCLC trial starting late 2026, targeting KRAS G12C resistance.
Amplia Therapeutics will combine narmafotinib with Lilly's olomorasib in a Phase 1b/2b NSCLC trial starting late 2026, targeting KRAS G12C resistance.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

CG Oncology awaits PIVOT-006 Phase 3 data as BLA filing nears

CG Oncology says PIVOT-006 has accrued most target events, with topline data imminent and a BLA submission for bladder cancer due in Q4 2026.
CG Oncology says PIVOT-006 has accrued most target events, with topline data imminent and a BLA submission for bladder cancer due in Q4 2026.
The Biotech Times Editorial Team  · 
Biologics

IN8bio GBM data shows mOS above 19.5 months in repeat-dose patients

IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
The Biotech Times Editorial Team  · 
Biologics

Cellectis lasme-cel wins FDA RMAT tag ahead of Phase 2 interim read

Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
The Biotech Times Editorial Team  · 
Biologics

BriaCell wins FDA clearance for Bria-PROS+ prostate cancer study

BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
The Biotech Times Editorial Team  · 
Diagnostics

Biodesix posts 34% revenue growth in Q2 2026 on lung test volumes

The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
The Biotech Times Editorial Team  · 
Diagnostics

Black Diamond reports 86% CNS response rate for silevertinib in NSCLC

Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
The Biotech Times Editorial Team  · 
Biologics

Novo Nordisk raises 2026 guidance as Wegovy pill tops 5m prescriptions

Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
The Biotech Times Editorial Team  · 
Biologics

Syndax posts $73m Q2 revenue as both approved drugs top $200m run rate

Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
The Biotech Times Editorial Team  · 
Biologics

Nurix and Roche enrol first patient in Phase 3 bexobrutideg CLL trial

The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

Eyonis and Olea Medical partner to expand AI lung cancer screening in US

Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
The Biotech Times Editorial Team  · 
Biologics

AIM ImmunoTech reaches last-dose milestone early in DURIPANC trial

The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

Lonza and Engitix strike ADC licence deal targeting ECM biology

Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
The Biotech Times Editorial Team  · 
Regulatory Science

UroGen secures US patent protecting ZUSDURI to July 2044

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
The Biotech Times Editorial Team  · 
Biologics

EPO upholds SOT201 patent for SOTIO's PD-1 immunocytokine

SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Leads Biolabs wins IND approval for Opamtistomig in metastatic CRC

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
The Biotech Times Editorial Team  · 
Biologics

Amplia Therapeutics publishes narmafotinib pancreatic cancer preprint

A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
The Biotech Times Editorial Team  · 

Aprea Therapeutics expands APR-1051 trial to ten sites ahead of Q4 data

Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
The Biotech Times Editorial Team  · 
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