Biotech
Diagnostics
Bioinformatics

Holobiome and Radicle Science launch 6,000-person gut-brain trial

The ARPA-H-backed GUT-FEELINGS study will test 19 prebiotic formulas against anxiety outcomes across 6,000 participants, with initial results expected in late
The ARPA-H-backed GUT-FEELINGS study will test 19 prebiotic formulas against anxiety outcomes across 6,000 participants, with initial results expected in late
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Pharvaris HAE pill data published in The Lancet ahead of FDA review

Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due
Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Agomab to present STENOVA OLE data at UEG Week 2026

Agomab's ontunisertib Phase 2a extension data in fibrostenosing Crohn's disease will be presented orally at UEG Week as the company readies its Phase
Agomab's ontunisertib Phase 2a extension data in fibrostenosing Crohn's disease will be presented orally at UEG Week as the company readies its Phase
The Biotech Times Editorial Team  · 
Diagnostics
Genomics
Biologics

Myriad Genetics and SOPHiA GENETICS team up on prostate HRD biomarker

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The Biotech Times Editorial Team  · 
Medical Devices

Spirair publishes six-month Vayu Study data for SeptAlign implant

Peer-reviewed results show a 63% reduction in nasal obstruction scores at six months, with no serious adverse events recorded across 75 patients.
Peer-reviewed results show a 63% reduction in nasal obstruction scores at six months, with no serious adverse events recorded across 75 patients.
The Biotech Times Editorial Team  · 
Medical Devices

MMI raises $125m Series D to scale Symani robotic microsurgery

Medical Microinstruments secured the oversubscribed round to expand its Symani Surgical System globally, with around 50 systems installed and 3,500 procedures completed.
Medical Microinstruments secured the oversubscribed round to expand its Symani Surgical System globally, with around 50 systems installed and 3,500 procedures completed.
The Biotech Times Editorial Team  · 
Medical Devices

Iantrek reports 37% IOP reduction in bio-reinforced canaloplasty study

Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.
Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics
Pharmaceuticals
Biologics

Editas Medicine clears first hurdle for EDIT-401 hyperlipidaemia trial

Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

X4 Pharmaceuticals secures $150m debt facility with K2 HealthVentures

The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.
The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Cell & Gene Therapy

Cullinan Therapeutics doses first patient in pivotal CLN-049 AML study

The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics
Bioprocessing

UAE biopharma push targets double-digit precision medicine growth

A Frost & Sullivan report for World Health Expo projects over 10% annual precision medicine growth in the Middle East over the next five to seven
A Frost & Sullivan report for World Health Expo projects over 10% annual precision medicine growth in the Middle East over the next five to seven
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

vTv Therapeutics wins FDA Orphan Drug tag for HPPD in sickle cell

The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
The Biotech Times Editorial Team  · 
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