North America

The United States and Canada.
Cell & Gene Therapy

Cell therapy's second act: why Boston is still winning

Four years after the first wave of CAR-T IPOs, Massachusetts is quietly becoming the centre of gravity for the next generation of cell therapies — this time, for solid tumours.

When the FDA approved the first CAR-T therapy for leukaemia in 2017, the assumption across the industry was that the blood cancer playbook would translate quickly into solid tumours. It did not.

Mark Walker  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 

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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 

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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Biotech

Zymeworks ZW191 posts 78.6% response rate in FRα-positive ovarian cancer

Phase 1 data for the ADC showed activity across both FRα-positive and FRα-negative platinum-resistant ovarian cancer patients at ESMO Gynaecological Cancers 2026.
Phase 1 data for the ADC showed activity across both FRα-positive and FRα-negative platinum-resistant ovarian cancer patients at ESMO Gynaecological Cancers 2026.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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%.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Legend Biotech's in vivo CAR-T LB2501 hits 100% ORR in NHL Phase 1

Legend Biotech reported a 100% objective response rate at the higher dose level of LB2501, its in vivo CD19/CD20 dual-targeting CAR-T, without
Legend Biotech reported a 100% objective response rate at the higher dose level of LB2501, its in vivo CD19/CD20 dual-targeting CAR-T, without
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Parabilis Medicines raises $745m in upsized Nasdaq IPO

The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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