Clinical Trials

Pharmaceuticals

Kymera Therapeutics doses first participant in IRAK4 degrader trial

KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
Pharmaceuticals

Sanofi halts MOBILIZE Phase 3 trial of riliprubart in refractory CIDP

An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
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.
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.
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.

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.
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.

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.

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.
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.
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

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.
Regulatory Science

Telitacicept wins NMPA approval for Sjögren's disease in China

RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI
RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI
Regulatory Science

Telitacicept wins NMPA conditional approval for IgA nephropathy

China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.
China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.
Regulatory Science

Agios licenses SYK inhibitor cevidoplenib from Oscotec in $1bn ITP deal

Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
Diagnostics

Boehringer's survodutide hits Phase III endpoints in obesity and MASLD

Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
Diagnostics

Diasome Phase 2b data shows HDV-insulin cuts hypoglycemia in T1D

OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
Biotech

Nurix and Roche strike $2.3bn BTK degrader collaboration

Nurix Therapeutics receives $700m upfront from Roche to co-develop bexobrutideg across blood cancers, multiple sclerosis and urticaria.
Nurix Therapeutics receives $700m upfront from Roche to co-develop bexobrutideg across blood cancers, multiple sclerosis and urticaria.
Regulatory Science

PharmAla Biotech licenses ALA-002 U.S. rights to Jupiter Neurosciences

PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
Pharmaceuticals

Roche and Nurix strike $2.3bn BTK degrader deal for bexobrutideg

Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
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