Biologics

Manufactured-protein therapeutics: monoclonal antibodies (mAbs); bispecifics & fusion proteins; therapeutic proteins & enzymes; vaccines; and blood & plasma products. Distinct from Cell & Gene Therapy (living cells / genetic material) and from chemically-synthesised small molecules (which stay under Pharmaceuticals).

Biologics
Pharmaceuticals

Climb Bio to show Phase 2 budoprutug and CLYM116 data at ASN 2026

Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Gain Therapeutics: rexaceract holds motor scores stable at 12 months

Phase 1b open-label extension data show no clinically meaningful motor progression in 12 Parkinson's patients after a full year of daily oral rexaceract.
Phase 1b open-label extension data show no clinically meaningful motor progression in 12 Parkinson's patients after a full year of daily oral rexaceract.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novo Nordisk's denecimig BLA delayed by manufacturing site remediation

The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.
The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Amplio Pharma Phase 1b data back NovoBioJect methotrexate booster

The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

Artiva to present AlloNK autoimmune data across 34 patients at ACR 2026

Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Biogen litifilimab CLE data show durable skin clearance at 52 weeks

Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Century Therapeutics' CNTY-813 hits IND-readiness milestones at EASD

Nonclinical data for the iPSC-derived islet therapy showed consistent manufacturing and durable glycaemic control, with an IND filing due in Q4 2026.
Nonclinical data for the iPSC-derived islet therapy showed consistent manufacturing and durable glycaemic control, with an IND filing due in Q4 2026.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novo semaglutide data show liver fat normalised in 88% of obese adults

Novo Nordisk presented STEP UP sub-analysis at EASD 2026 showing Wegovy reduced mean liver fat from 8.8% to 3.1% over 72 weeks
Novo Nordisk presented STEP UP sub-analysis at EASD 2026 showing Wegovy reduced mean liver fat from 8.8% to 3.1% over 72 weeks
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Boehringer's survodutide hits Phase III endpoints in obesity plus T2D

SYNCHRONIZE-2 showed 13.1% average weight loss versus 3.1% on placebo after 76 weeks, with significant glycaemic improvements published in the NEJM.
SYNCHRONIZE-2 showed 13.1% average weight loss versus 3.1% on placebo after 76 weeks, with significant glycaemic improvements published in the NEJM.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Sanofi and Regeneron expand immunology alliance with $8bn deal

Four next-generation long-acting antibodies targeting IL-13, IL-4 and IL-4Rα join the partnership that produced Dupixent, with Regeneron receiving $1bn upfront.
Four next-generation long-acting antibodies targeting IL-13, IL-4 and IL-4Rα join the partnership that produced Dupixent, with Regeneron receiving $1bn upfront.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Survodutide hits 13.1% weight loss in Phase III obesity-T2D trial

Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Genomics

Atsena's ATSN-201 shows durable XLRS benefit at 18 months

Atsena Therapeutics reported sustained structural and functional gains in seven of nine treated eyes, with a BLA filing now targeted for late 2028.
Atsena Therapeutics reported sustained structural and functional gains in seven of nine treated eyes, with a BLA filing now targeted for late 2028.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

Candel reports durable immune remodelling data for aglatimagene

AI-enabled digital pathology shows aglatimagene drove sustained lymphocyte-tumour engagement more than two years after treatment in a phase 3 prostate cancer trial.
AI-enabled digital pathology shows aglatimagene drove sustained lymphocyte-tumour engagement more than two years after treatment in a phase 3 prostate cancer trial.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Connect Biopharma: rademikibart cuts COPD failure rate 81% in Ph2

Connect Biopharma's IL-4Rα antibody rademikibart met its primary endpoint in a Phase 2 COPD trial, eliminating hospital return visits versus placebo.
Connect Biopharma's IL-4Rα antibody rademikibart met its primary endpoint in a Phase 2 COPD trial, eliminating hospital return visits versus placebo.
The Biotech Times Editorial Team  · 
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