Clinical Trials

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
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
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
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.
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.
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.
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.
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.
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
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.
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
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
Biologics
Regulatory Science

uniQure to file AMT-130 BLA for Huntington's disease in Q3 2026

The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
Biologics

Utebzi approved as first oral carbapenem for cUTIs in the US

The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
Biologics

Zelluna ASA raises NOK 58m ahead of first TCR-NK clinical data

The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
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.
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.
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.
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.
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.
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