Regulatory Science

NeOnc secures UAE IND clearance for brain tumour drug NEO212

NeOnc Technologies has gained Abu Dhabi regulatory clearance for NEO212 after Phase 1 established a recommended dose in recurrent glioblastoma patients.
NeOnc Technologies has gained Abu Dhabi regulatory clearance for NEO212 after Phase 1 established a recommended dose in recurrent glioblastoma patients.
The Biotech Times Editorial Team  · 
Diagnostics

BioAge Labs doses first participant in Phase 2 NLRP3 trial QUELL-CV

BioAge's BGE-102 enters a 160-person dose-ranging trial targeting cardiovascular inflammation, with topline hsCRP data expected in the second half of 2026.
BioAge's BGE-102 enters a 160-person dose-ranging trial targeting cardiovascular inflammation, with topline hsCRP data expected in the second half of 2026.
The Biotech Times Editorial Team  · 
Regulatory Science

Inventiva secures €130m debt facility to fund lanifibranor Phase 3

Claret Capital Partners and BlackRock are co-funding a €130m package backing Inventiva's MASH candidate lanifibranor ahead of a Q4 2026 trial readout.
Claret Capital Partners and BlackRock are co-funding a €130m package backing Inventiva's MASH candidate lanifibranor ahead of a Q4 2026 trial readout.
The Biotech Times Editorial Team  · 
Diagnostics

ConSynance doses first patient in Phase 2a PWS trial of CSTI-500

ConSynance Therapeutics has begun a proof-of-concept trial of its oral triple monoamine reuptake inhibitor in up to 12 Prader-Willi syndrome patients.
ConSynance Therapeutics has begun a proof-of-concept trial of its oral triple monoamine reuptake inhibitor in up to 12 Prader-Willi syndrome patients.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

iMDx GraftAssure matches NGS rival in kidney transplant study

GraftAssure showed 99.2% agreement with a leading NGS-based assay in kidney transplant rejection monitoring, with superior analytical sensitivity at low dd-cfDNA levels.
GraftAssure showed 99.2% agreement with a leading NGS-based assay in kidney transplant rejection monitoring, with superior analytical sensitivity at low dd-cfDNA levels.
The Biotech Times Editorial Team  · 
Biotech

HCW Biologics reports Phase 1 signal for IL-2 fusion drug in alopecia

All three patients in the second dose cohort of HCW9302 showed at least a 25% improvement in SALT scores after a single subcutaneous dose.
All three patients in the second dose cohort of HCW9302 showed at least a 25% improvement in SALT scores after a single subcutaneous dose.
The Biotech Times Editorial Team  · 
Genomics

NMD Pharma's ignaseclant shows muscle gains in Phase 2a CMT study

Ignaseclant met multiple secondary functional endpoints in 81 CMT patients, with benefits persisting seven days after the 21-day treatment ended.
Ignaseclant met multiple secondary functional endpoints in 81 CMT patients, with benefits persisting seven days after the 21-day treatment ended.
The Biotech Times Editorial Team  · 
Biotech
Regulatory Science

Humacyte prices $50m public offering to fund Symvess rollout

Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
The Biotech Times Editorial Team  · 
Regulatory Science

NovaBridge wins FDA Fast Track for givastomig in gastric cancer

NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
The Biotech Times Editorial Team  · 

nCAP Medical RCT shows NeuroCuple cuts opioid use after knee surgery

A peer-reviewed randomised trial found the nanotechnology device reduced in-hospital opioid consumption by 26% and shortened stays by 19% after total knee arthroplasty.
A peer-reviewed randomised trial found the nanotechnology device reduced in-hospital opioid consumption by 26% and shortened stays by 19% after total knee arthroplasty.
The Biotech Times Editorial Team  · 
Diagnostics

Invivyd completes enrolment in Phase 3 LIBERTY COVID antibody trial

Invivyd has finished enrolling 210 participants in LIBERTY, its Phase 3 head-to-head study of VYD2311 against an mRNA COVID-19 vaccine, with topline
Invivyd has finished enrolling 210 participants in LIBERTY, its Phase 3 head-to-head study of VYD2311 against an mRNA COVID-19 vaccine, with topline
The Biotech Times Editorial Team  · 
Regulatory Science

Cardiawave begins routine EU rollout of Valvosoft aortic stenosis device

The French medtech has treated its first routine patients in France, the Netherlands and Germany with its non-invasive ultrasound device for severe aortic stenosis.
The French medtech has treated its first routine patients in France, the Netherlands and Germany with its non-invasive ultrasound device for severe aortic stenosis.
The Biotech Times Editorial Team  · 
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