Disease

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.
Diagnostics
Digital Health
Genomics

Nano Dimension signs term sheet to merge with Infinite Epigenetics

Nano Dimension is pivoting from digital manufacturing into epigenetic diagnostics via a proposed $890m combination with AI-powered Infinite Epigenetics.
Nano Dimension is pivoting from digital manufacturing into epigenetic diagnostics via a proposed $890m combination with AI-powered Infinite Epigenetics.
Biotech

XBiotech launches Phase II axial spondyloarthritis trial of vilamakitug

XBiotech's V-SPINE study cleared FDA review without clinical hold, opening US enrolment for its IL-1α antibody vilamakitug in axSpA.
XBiotech's V-SPINE study cleared FDA review without clinical hold, opening US enrolment for its IL-1α antibody vilamakitug in axSpA.
Synthetic Biology
Biotech

Celldex CDX-622 shows durable mast cell depletion in Phase 1 data

First-in-human results for the bispecific antibody showed rapid, dose-dependent serum tryptase reductions and a clean safety profile across all dose levels.
First-in-human results for the bispecific antibody showed rapid, dose-dependent serum tryptase reductions and a clean safety profile across all dose levels.
Regulatory Science

Crinetics presents Phase 2 atumelnant CAH data at ENDO 2026

Full results from Cohort 4 showed 88% of participants achieved physiologic glucocorticoid doses alongside sustained androgen reductions of up to 67%.
Full results from Cohort 4 showed 88% of participants achieved physiologic glucocorticoid doses alongside sustained androgen reductions of up to 67%.
Regulatory Science

Crinetics paltusotine shows durable acromegaly control at two years

Pooled PATHFNDR open-label extension data show paltusotine maintained IGF-1 control and stable tumour volumes for up to 96 weeks in acromegaly patients.
Pooled PATHFNDR open-label extension data show paltusotine maintained IGF-1 control and stable tumour volumes for up to 96 weeks in acromegaly patients.
Diagnostics

Eliaz Therapeutics opens Reg CF round to fund sepsis apheresis device

The California biotech is crowdfunding to advance XGal-3, an FDA Breakthrough Device-designated apheresis system targeting Galectin-3 in sepsis.
The California biotech is crowdfunding to advance XGal-3, an FDA Breakthrough Device-designated apheresis system targeting Galectin-3 in sepsis.
Diagnostics

Intrommune reports exploratory peanut tolerance data for OMIT

Intrommune Therapeutics presented Phase 1 exploratory data showing all INT301-treated adults tolerated peanut protein at 50 times their baseline dose.
Intrommune Therapeutics presented Phase 1 exploratory data showing all INT301-treated adults tolerated peanut protein at 50 times their baseline dose.
Pharmaceuticals

Menarini selinexor combo meets spleen endpoint in Phase 3 MF

Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
Proteomics
Regulatory Science

Mineralys presents lorundrostat HF biomarker data at ENDO 2026

Proteomic analysis of over 1,000 trial participants found lorundrostat reduced six of eleven heart failure risk biomarkers, including NT-proBNP.
Proteomic analysis of over 1,000 trial participants found lorundrostat reduced six of eleven heart failure risk biomarkers, including NT-proBNP.
Diagnostics

Upstream Bio verekitug met NPS target in 79% of VIBRANT patients

Post-hoc responder analyses from the Phase 2 VIBRANT trial show verekitug achieved clinically meaningful nasal polyp improvements in roughly four in five treated
Post-hoc responder analyses from the Phase 2 VIBRANT trial show verekitug achieved clinically meaningful nasal polyp improvements in roughly four in five treated
Diagnostics

Vivoryon touts DKD kidney data as it hunts Phase 2b partner

The Dutch biotech reported compelling eGFR data in diabetic kidney disease patients and confirmed cash runway only into Q4 2026 as partnership talks continue.
The Dutch biotech reported compelling eGFR data in diabetic kidney disease patients and confirmed cash runway only into Q4 2026 as partnership talks continue.
Genomics

AC Immune gets $4m Goradia grant to extend Parkinson's vaccine trial

The philanthropic grant extends Part 1 of the Phase 2 VacSYn trial of ACI-7104 by two years, with final Part 1 data due in
The philanthropic grant extends Part 1 of the Phase 2 VacSYn trial of ACI-7104 by two years, with final Part 1 data due in
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