Biologics
Pharmaceuticals

Climb Bio CLYM116 Phase 1 data back every-12-week dosing in IgAN

Phase 1 data show CLYM116 achieved near-complete APRIL suppression and a 29-day half-life, supporting quarterly dosing in IgA nephropathy.
Phase 1 data show CLYM116 achieved near-complete APRIL suppression and a 29-day half-life, supporting quarterly dosing in IgA nephropathy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Canada's CDA-AMC backs conditional reimbursement for Yorvipath

Palopegteriparatide gains a positive reimbursement recommendation in Canada for adults with chronic hypoparathyroidism inadequately controlled on standard therapy.
Palopegteriparatide gains a positive reimbursement recommendation in Canada for adults with chronic hypoparathyroidism inadequately controlled on standard therapy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Ultragenyx Phase 3 Aspire trial fails in Angelman syndrome

Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

AiM Medical Robotics wins $2m NCI grant for MRI brain robot

The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Attovia Therapeutics raises $332m IPO as itch drug shows Phase 1b signal

The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

HUTCHMED licenses KRAS-EGFR conjugate HMPL-A830 to GSK for $1.3bn

GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Inventiva completes patient visits in NATiV3 MASH Phase 3 trial

Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Lecanemab subcutaneous autoinjector approved in China for early AD

China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Opus Genetics to unveil OPGx-BEST1 Phase 1/2 data on 9 September

The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The Biotech Times Editorial Team  · 
Medical Devices

Nyxoah ACCCESS study hits safety and efficacy endpoints in CCC patients

Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA
Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

Transgene TG4050 sustains 100% disease-free survival at three years

All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Genomics

Scribe Therapeutics IPO raises $155m as STX-1150 enters clinic

The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
The Biotech Times Editorial Team  · 
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