Cell & Gene Therapy

TG Therapeutics launches Phase 2 MG trial after positive BRIUMVI data

Subcutaneous BRIUMVI hit MCID in 82% of myasthenia gravis patients at Week 24, prompting a potentially registration-directed Phase 2 sequential-therapy trial.
Subcutaneous BRIUMVI hit MCID in 82% of myasthenia gravis patients at Week 24, prompting a potentially registration-directed Phase 2 sequential-therapy trial.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Windward Bio doses first patients in Phase 2 COPD study of WIN378

The Basel biotech has initiated SIRIUS, a Phase 2 COPD trial of its twice-yearly anti-TSLP antibody WIN378, alongside an ongoing asthma programme.
The Basel biotech has initiated SIRIUS, a Phase 2 COPD trial of its twice-yearly anti-TSLP antibody WIN378, alongside an ongoing asthma programme.
The Biotech Times Editorial Team  · 
Genomics

Alkeus Pharmaceuticals doses first patient in Phase 3 Stargardt trial

The Cambridge biotech has initiated its pivotal NORTHSTAR study of oral gildeuretinol in Stargardt disease, with no approved treatment currently available.
The Cambridge biotech has initiated its pivotal NORTHSTAR study of oral gildeuretinol in Stargardt disease, with no approved treatment currently available.
The Biotech Times Editorial Team  · 
Bioprocessing
Regulatory Science

Alvotech wins FDA review acceptance for AVT16 vedolizumab biosimilar

The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis
The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis
The Biotech Times Editorial Team  · 

Artiva's AlloNK wins FDA RMAT tag as EULAR data show 71% ACR50 in RA

Artiva Biotherapeutics secured RMAT designation for its allogeneic NK cell therapy after Phase 2a data showed durable responses in refractory rheumatoid arthritis.
Artiva Biotherapeutics secured RMAT designation for its allogeneic NK cell therapy after Phase 2a data showed durable responses in refractory rheumatoid arthritis.
The Biotech Times Editorial Team  · 
Diagnostics

DBV Technologies presents VITESSE subgroup data at EAACI 2026

New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
The Biotech Times Editorial Team  · 

Eledon's tegoprubart hits 100% insulin independence in T1D islet trial

All 12 patients in a UChicago Medicine pilot achieved insulin independence, with mean HbA1c of 5.4% and no severe hypoglycaemic episodes post-transplant.
All 12 patients in a UChicago Medicine pilot achieved insulin independence, with mean HbA1c of 5.4% and no severe hypoglycaemic episodes post-transplant.
The Biotech Times Editorial Team  · 

Lyell Immunopharma upgrades LYL273 to Phase 1/2 design

GI prophylaxis cut Grade 2+ diarrhoea and colitis from 55% to 10% in the GCC-targeted CAR T-cell trial for metastatic colorectal cancer.
GI prophylaxis cut Grade 2+ diarrhoea and colitis from 55% to 10% in the GCC-targeted CAR T-cell trial for metastatic colorectal cancer.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics

Sangamo hires Raymond James to explore strategic alternatives

The genomic medicine company is weighing a sale or partnership as it advances a BLA-ready Fabry gene therapy and two CNS programmes.
The genomic medicine company is weighing a sale or partnership as it advances a BLA-ready Fabry gene therapy and two CNS programmes.
The Biotech Times Editorial Team  · 
Diagnostics

Sequel Med Tech twiist AID System cuts HbA1c in type 2 pivotal trial

A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
The Biotech Times Editorial Team  · 
Diagnostics

Sparrow Pharma Phase 2a data back clofutriben in Type 2 diabetes

Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched
Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched
The Biotech Times Editorial Team  · 

Standard BioTools and Treeline Biosciences agree all-stock merger

The combined company will operate as Treeline Biosciences, with over $900m in cash and three Phase 1 oncology programmes already under way.
The combined company will operate as Treeline Biosciences, with over $900m in cash and three Phase 1 oncology programmes already under way.
The Biotech Times Editorial Team  · 
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