Disease

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.

Nyxoah draws $15m EIB tranche to fund US Genio launch

The Belgian sleep-apnea medtech has completed a $110m capital raise in June, combining equity proceeds with non-dilutive EIB debt financing.
The Belgian sleep-apnea medtech has completed a $110m capital raise in June, combining equity proceeds with non-dilutive EIB debt financing.
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.
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.
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.
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
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.
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
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.
Diagnostics

Applied Biologics' XWRAP hits wound closure endpoint in CAMPX trial

Updated analyses of the CAMPX randomised trial show XWRAP plus standard care achieved complete wound closure in 31% of diabetic foot ulcer patients versus 18
Updated analyses of the CAMPX randomised trial show XWRAP plus standard care achieved complete wound closure in 31% of diabetic foot ulcer patients versus 18
Diagnostics

Aptose reports 86% response rate in AML triplet therapy trial at EHA

Phase 1/2 TUSCANY data show tuspetinib plus venetoclax and azacitidine achieved deep remissions across diverse AML mutations, including historically difficult
Phase 1/2 TUSCANY data show tuspetinib plus venetoclax and azacitidine achieved deep remissions across diverse AML mutations, including historically difficult
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.

Context Therapeutics: CTIM-76 hits 29% ORR in ovarian cancer

Phase 1 interim data showed a 29% confirmed overall response rate in heavily pretreated platinum-resistant ovarian cancer patients, with mostly Grade 1 adverse events.
Phase 1 interim data showed a 29% confirmed overall response rate in heavily pretreated platinum-resistant ovarian cancer patients, with mostly Grade 1 adverse events.
Regulatory Science
Biotech

Cuprina wins FDA 510(k) clearance for MEDIFLY Lucilia cuprina maggots

Singapore-based Cuprina now holds FDA commercial rights to both maggot species used in debridement therapy, a position the company says no rival holds.
Singapore-based Cuprina now holds FDA commercial rights to both maggot species used in debridement therapy, a position the company says no rival holds.
Genomics
Diagnostics

Pharvaris deucrictibant Phase 3 HAE data presented at EAACI 2026

Pharvaris reported Phase 3 RAPIDe-3 data showing deucrictibant halted HAE attack progression in a median 17 minutes versus nearly four hours for placebo.
Pharvaris reported Phase 3 RAPIDe-3 data showing deucrictibant halted HAE attack progression in a median 17 minutes versus nearly four hours for placebo.
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