Clinical Trials

Biologics
Pharmaceuticals

argenx halts Phase 3 UNITY trial of efgartigimod in Sjögren's disease

An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
Biotech
Bioinformatics

Bexorg wins up to $28.3m ARPA-H award to extend human brain perfusion

The New Haven CNS platform company will use the 36-month grant to push its BrainEx system from 24-hour to two-week intact human
The New Haven CNS platform company will use the 36-month grant to push its BrainEx system from 24-hour to two-week intact human
Medical Devices
Diagnostics
Regulatory Science

SeaStar Medical wins seventh Breakthrough Device tag for SCD in sepsis

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
Pharmaceuticals
Biologics

Novartis wins FDA approval for Rhapsido in symptomatic dermographism

Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Cell & Gene Therapy
Biologics
Medical Devices

GenSight optogenetic therapy safe and restores object detection

A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
Pharmaceuticals
Biologics

Rezera: ruvonoflast cuts inflammation added to semaglutide

Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Medical Devices
Biologics

TISSIUM begins US enrolment in UNITE hernia fixation trial

TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
Biologics
Pharmaceuticals

Vaxcyte raises ~$1bn via equity and convertible notes to fund VAX-31

Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
Pharmaceuticals
Biologics

Zealand Pharma's petrelintide hits Phase 2 weight and glycaemic goals

Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
Pharmaceuticals
Biologics

ArriVent firmonertinib misses Phase 3 PFS endpoint in NSCLC

The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
Pharmaceuticals
Genomics

BridgeBio to present CALIBRATE Phase 3 encaleret data at ASBMR 2026

BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
Pharmaceuticals
Biologics

Jupiter Neurosciences doses first patient in Phase 2a Parkinson's trial

Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
Pharmaceuticals
Biologics

RougeTx launches with $58m Series A to target HHT bleeding disorder

The Leiden spin-out is advancing RTX-001, a once-daily oral pericyte-targeting candidate, toward first-in-human trials in a condition with no
The Leiden spin-out is advancing RTX-001, a once-daily oral pericyte-targeting candidate, toward first-in-human trials in a condition with no
Biologics
Pharmaceuticals

Epcoritamab plus R-CHOP cuts DLBCL progression risk by 51% in Phase 3

Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
Cell & Gene Therapy
Genomics

AAVantgarde sees early efficacy signals in dual-AAV eye therapy

AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
Cell & Gene Therapy
Biologics

CAR-T safety events dent rheumatologist confidence, Spherix finds

A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova confirm Klotho secretion in encapsulated cells

Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
Cell & Gene Therapy

Ernexa Therapeutics names Spiegel to board ahead of ERNA-101 IND

Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Medical Devices
Diagnostics

Autonomix Medical secures FDA support for 510(k) sensing platform

Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
Biologics
Pharmaceuticals

Climb Bio to show Phase 2 budoprutug and CLYM116 data at ASN 2026

Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
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