Clinical Trials

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
Regulatory Science

Sanofi wins Japan approval for Sarclisa subcutaneous formulation

Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
The Biotech Times Editorial Team  · 
Regulatory Science

Nerandomilast modelling predicts multi-year survival gain in IPF

Boehringer Ingelheim survival models predict nerandomilast could more than double median IPF survival, based on Phase III FIBRONEER trial data.
Boehringer Ingelheim survival models predict nerandomilast could more than double median IPF survival, based on Phase III FIBRONEER trial data.
The Biotech Times Editorial Team  · 
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  · 
Biologics

Kither Biotech completes Phase 1 of inhaled peptide KIT2014 in COPD

The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
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  · 
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  · 
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  · 
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  · 
Biologics

Biogen to acquire RayThera for up to $1bn to bolster immunology pipeline

Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
The Biotech Times Editorial Team  · 
Diagnostics

Avalyn completes Phase 2b MIST enrollment for inhaled pirfenidone

Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
The Biotech Times Editorial Team  · 
Biologics

Connect Biopharma fills Phase 2 asthma study of rademikibart

The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The Biotech Times Editorial Team  · 
Regulatory Science

F2G and Shionogi's olorofim meets Phase 3 non-inferiority endpoint

Olorofim matched liposomal amphotericin B on 42-day mortality in azole-refractory invasive aspergillosis, with a markedly lower adverse-event burden.
Olorofim matched liposomal amphotericin B on 42-day mortality in azole-refractory invasive aspergillosis, with a markedly lower adverse-event burden.
The Biotech Times Editorial Team  · 
Biologics

Roche files sBLA for Lunsumio-Polivy combo in relapsed LBCL

The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The Biotech Times Editorial Team  · 
Biologics

Lexeo Therapeutics publishes LX2006 Phase I/II data in JAMA Cardiology

Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sernova wins FDA Orphan Drug tag for autologous islet transplant

The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Biotech Times Editorial Team  · 
Biologics

Odyssey Therapeutics IPO raises $315m as OD-001 hits UC proof-of-concept

The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Biotech Times Editorial Team  · 
Subscribe to Clinical Trials