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

ACTG launches alendronate trial to test HIV reservoir clearance

The global HIV trials network is testing a common osteoporosis drug as a latency-reversing agent in a 30-person randomised, placebo-controlled study.
The global HIV trials network is testing a common osteoporosis drug as a latency-reversing agent in a 30-person randomised, placebo-controlled study.
The Biotech Times Editorial Team  · 
Biologics

Vascudyne bioengineered coronary graft sustains 18-month patency

Vascudyne's acellular tissue-engineered vessel maintained full patency for 18 months in a large-animal CABG model, with anticoagulation stopped at six months.
Vascudyne's acellular tissue-engineered vessel maintained full patency for 18 months in a large-animal CABG model, with anticoagulation stopped at six months.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Humacyte V007 Phase 3 ATEV data published in Lancet Digital Health

Humacyte's peer-reviewed Phase 3 data show its bioengineered vessel outperformed standard fistulas in women and obese or diabetic men on haemodialysis.
Humacyte's peer-reviewed Phase 3 data show its bioengineered vessel outperformed standard fistulas in women and obese or diabetic men on haemodialysis.
The Biotech Times Editorial Team  · 
Biologics

VarmX enrols first patient in Phase 3 trial of FXa reversal agent

VarmX has begun enrolling patients in EquilibriX-S, its pivotal Phase 3 study of VMX-C001 for urgent surgery in patients on Factor Xa inhibitors.
VarmX has begun enrolling patients in EquilibriX-S, its pivotal Phase 3 study of VMX-C001 for urgent surgery in patients on Factor Xa inhibitors.
The Biotech Times Editorial Team  · 
Biologics

MiNK Therapeutics reports Day 28 survival data from agenT-797 Phase 2

Early observations from MiNK's randomised Phase 2 in severe hypoxemic pneumonia showed treated patients alive, afebrile and off ventilator support at Day 28.
Early observations from MiNK's randomised Phase 2 in severe hypoxemic pneumonia showed treated patients alive, afebrile and off ventilator support at Day 28.
The Biotech Times Editorial Team  · 
Biologics

Entera Bio raises $275m to fund EB613 oral osteoporosis Phase 3

The Tel Aviv-listed biotech secured an oversubscribed PIPE to take its oral PTH(1-34) tablet through a registrational trial and NDA submission.
The Tel Aviv-listed biotech secured an oversubscribed PIPE to take its oral PTH(1-34) tablet through a registrational trial and NDA submission.
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  · 
Biologics
Regulatory Science

Bavarian Nordic wins EC approval of mpox vaccine for young children

IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.
IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.
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

CurePSP's PSP Trial Platform enrols first participant

The $75.4m NIA-funded platform trial will test multiple PSP drugs simultaneously at 50 US sites, enrolling 440 participants over two years.
The $75.4m NIA-funded platform trial will test multiple PSP drugs simultaneously at 50 US sites, enrolling 440 participants over two years.
The Biotech Times Editorial Team  · 
Biologics

PSP Trial Platform enrols first participant in multi-drug study

The UCSF-led platform trial, backed by $75.4m in NIH funding, will test multiple drugs simultaneously across 50 sites in the US.
The UCSF-led platform trial, backed by $75.4m in NIH funding, will test multiple drugs simultaneously across 50 sites in the US.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Artiva Biotherapeutics initiates Phase 3 RA trial after RMAT designation

Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
The Biotech Times Editorial Team  · 
Biologics

Ascendis reports durable growth data from COACH and ApproaCH trials

Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Pharvaris AAE-C1INH burden study published in Frontiers Immunology

Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.
Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.
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

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

Adneuris licenses cebranopadol to Maruishi for Japan and South Korea

Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.
Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.
The Biotech Times Editorial Team  · 
Biologics

Arcutis raises 2026 guidance after ZORYVE revenue jumps 59%

Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.
Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.
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  · 
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