Oncology

Biologics

Monte Rosa doses first patient in Phase 2 MRT-2359 prostate cancer study

Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
Diagnostics

RenovoRx publishes PK/PD data showing 51% tumour-site drug extraction

Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
Diagnostics

Vivos Inc. ships first IsoPet batches from in-house US facility

Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
Biologics

Alvotech and Lotus Pharmaceutical sign biosimilar deal worth up to $150m

Alvotech has licensed two biosimilar candidates to Lotus Pharmaceutical across the US and eight Asian markets, with milestone payments potentially reaching $150 million.
Alvotech has licensed two biosimilar candidates to Lotus Pharmaceutical across the US and eight Asian markets, with milestone payments potentially reaching $150 million.
Regulatory Science

Erasca wins FDA Fast Track for pan-RAS molecular glue in PDAC

Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.
Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.
Biologics

Leads Biolabs' opamtistomig posts 65% ORR in Phase 2 NSCLC study

Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Biologics

J&J wins EC approval for teclistamab plus daratumumab in RRMM

The European Commission has approved the bispecific-antibody doublet for relapsed/refractory myeloma from second line, backed by Phase 3 survival data.
The European Commission has approved the bispecific-antibody doublet for relapsed/refractory myeloma from second line, backed by Phase 3 survival data.
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.

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.
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.
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.
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.
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.
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.
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
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.
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
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.
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.
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.
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