Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
The Biotech Times Editorial Team  · 
Diagnostics
Biotech

Trinity Biotech wins 2m TrinScreen HIV order; Q1 revenue up 43%

Trinity Biotech secured orders for over 2 million TrinScreen HIV rapid tests, supporting 2026 targets as Q1 revenue rose 43% to $10.8m.
Trinity Biotech secured orders for over 2 million TrinScreen HIV rapid tests, supporting 2026 targets as Q1 revenue rose 43% to $10.8m.
The Biotech Times Editorial Team  · 
Biologics

IMF ASCENT trial shows 82% five-year PFS in smouldering myeloma

Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
The Biotech Times Editorial Team  · 
Regulatory Science

Grace Therapeutics plans NDA resubmission after FDA CRL for GTx-104

Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Denali Therapeutics sells rare paediatric PRV for $195m

Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
The Biotech Times Editorial Team  · 
Synthetic Biology

Amber Implants expands EXPAND study of VCFix to eight European centres

The Dutch medtech has enrolled 15 patients and expanded its pivotal vertebral reconstruction trial across Germany and France.
The Dutch medtech has enrolled 15 patients and expanded its pivotal vertebral reconstruction trial across Germany and France.
The Biotech Times Editorial Team  · 
Regulatory Science

Teva files NDA for ecopipam in paediatric Tourette syndrome

Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
The Biotech Times Editorial Team  · 
Biologics
Genomics

Prime Medicine clears NZ hurdle for first in vivo Prime Editing trial

Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
The Biotech Times Editorial Team  · 
Biologics

Memo Therapeutics presents full Phase II potravitug data at ATC 2026

Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
The Biotech Times Editorial Team  · 
Regulatory Science

Nicox NCX 470 clears China pre-submission review ahead of dual NDA push

Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
The Biotech Times Editorial Team  · 
Biologics

Memento Medicines raises $93m Series A for retinal bispecific

The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The Biotech Times Editorial Team  · 

FocalTherics partners with MellingMedical to bring HIFU to VA system

FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
The Biotech Times Editorial Team  · 
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