North America

The United States and Canada.
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.
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.
Biotech
Regulatory Science

Humacyte prices $50m public offering to fund Symvess rollout

Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
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

nCAP Medical RCT shows NeuroCuple cuts opioid use after knee surgery

A peer-reviewed randomised trial found the nanotechnology device reduced in-hospital opioid consumption by 26% and shortened stays by 19% after total knee arthroplasty.
A peer-reviewed randomised trial found the nanotechnology device reduced in-hospital opioid consumption by 26% and shortened stays by 19% after total knee arthroplasty.
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
Diagnostics
Bioinformatics

Adaptive Biotechnologies plans to spin out Immune Medicine unit

The Seattle biotech will separate its profitable clonoSEQ MRD diagnostics arm from its AI-driven immune medicine discovery platform by end of 2026.
The Seattle biotech will separate its profitable clonoSEQ MRD diagnostics arm from its AI-driven immune medicine discovery platform by end of 2026.
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

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.

Legend Biotech reports 100% ORR for in vivo CAR-T LB2501 in B-NHL

Phase 1 data showed all six patients at the higher dose responded to a single infusion of LB2501, with no lymphodepletion required and no serious
Phase 1 data showed all six patients at the higher dose responded to a single infusion of LB2501, with no lymphodepletion required and no serious
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

VERAXA Biotech lists on Nasdaq via SPAC merger, raises $77.5m

The Swiss oncology biotech completes its Voyager Acquisition Corp. merger and begins trading under "VRXA" on 11 June 2026.
The Swiss oncology biotech completes its Voyager Acquisition Corp. merger and begins trading under "VRXA" on 11 June 2026.
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.
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