Oncology

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.

Moleculin AML trial holds 37% blinded CRc in venetoclax-failed patients

Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
Biologics

Leads Biolabs completes enrolment in Phase II BTC study of opamtistomig

The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
Biologics

FDA approves Pluvicto for hormone-sensitive prostate cancer

Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.

TScan Therapeutics doses first patient in Phase 3 ALLOHA-2 trial

TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
Biologics

Sanofi upgrades 2026 guidance after 17.8% Q2 sales growth

Sanofi posted Q2 net sales of €11.6 billion, lifted by Dupixent and pharma launches, and raised its full-year sales growth target to around
Sanofi posted Q2 net sales of €11.6 billion, lifted by Dupixent and pharma launches, and raised its full-year sales growth target to around
Biologics

Celcuity gedatolisib gains NCCN Category 1 status in breast cancer

REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
Biologics

Diakonos Oncology doses first patients in DOC1021 melanoma trial

The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
Biologics

Allogene wins FDA RMAT and Fast Track tags for cema-cel in LBCL

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Biologics

Ipsen raises FY 2026 guidance after 23.5% CER sales growth in H1

Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
Biologics

Compass Therapeutics tovecimig data wins oral slot at ESMO 2026

Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
Biologics

BriaCell adds Sunnybrook to Phase 3 breast cancer trial

Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
Biologics

Adlai Nortye doses first patient in weekly arm of AN9025 Phase 1

The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
Biologics

Allogene ALLO-316 achieves 31% response rate in solid tumour Phase 1

Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Diagnostics

Alpha Tau treats first immunocompromised cSCC patient in ADMIRE trial

Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Biologics

ENDURANCE trial: two-year lenalidomide matches lifelong therapy

A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
Biologics

Cellectar publishes Phase 1 iopofosine I 131 data in multiple myeloma

Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.

ORIC Pharmaceuticals starts Phase 3 Himalayas-1 trial in mCRPC

ORIC has dosed first patients in its 600-person global Phase 3 trial of rinzimetostat plus darolutamide, backed by a supply deal with Bayer.
ORIC has dosed first patients in its 600-person global Phase 3 trial of rinzimetostat plus darolutamide, backed by a supply deal with Bayer.
Biologics

InnoCare's orelabrutinib cuts CLL/SLL progression risk by 68% in Phase 3

Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.
Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.
Biologics
Regulatory Science

Elevar Therapeutics receives FDA CRL for rivoceranib-camrelizumab in HCC

The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
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