North America

The United States and Canada.
Pharmaceuticals
Bioinformatics

X-Chem wins Chordoma Foundation TBXT Challenge with novel binder

X-Chem beat 25 competing teams to become the first to bind Brachyury below 1 micromolar, validating its DEL-based Chemomics platform against a long
X-Chem beat 25 competing teams to become the first to bind Brachyury below 1 micromolar, validating its DEL-based Chemomics platform against a long
Genomics
Diagnostics

Bionano OGM detects hidden genomic risk in MDS and AML studies

Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
Pharmaceuticals
Diagnostics

BioVie's bezisterim hits subgroup endpoints in Phase 2 Long COVID trial

BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
Pharmaceuticals
Diagnostics

BlossomHill's BH-30643 hits 45% response rate in C797S NSCLC

Updated SOLARA Phase 1/2 data show an 88% disease control rate in a resistance population with no approved targeted therapies.
Updated SOLARA Phase 1/2 data show an 88% disease control rate in a resistance population with no approved targeted therapies.
Biologics
Pharmaceuticals

Connect Biopharma's rademikibart cuts asthma treatment failure by 66%

Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Pharmaceuticals
Diagnostics

Dogwood Therapeutics completes enrolment in Halneuron CINP Phase 2b

The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
Pharmaceuticals
Biologics

ENA Respiratory begins Part B dosing in INNA-051 Phase IIa study

The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
Pharmaceuticals

Kestrel Therapeutics wins FDA Fast Track for pan-KRAS inhibitor KST-6051

Kestrel's oral pan-KRAS inhibitor enters Phase 1 with Fast Track status, targeting KRAS-mutant solid tumours across PDAC, CRC and NSCLC.
Kestrel's oral pan-KRAS inhibitor enters Phase 1 with Fast Track status, targeting KRAS-mutant solid tumours across PDAC, CRC and NSCLC.
Biologics
Regulatory Science

PolarityBio wins FDA Priority Review for SkinTE BLA in DFUs

The FDA has accepted PolarityBio's SkinTE biologics application with Priority Review, setting a PDUFA action date of 16 March 2027.
The FDA has accepted PolarityBio's SkinTE biologics application with Priority Review, setting a PDUFA action date of 16 March 2027.
Biologics
Regulatory Science

Vera Therapeutics' TRUTAKNA cuts IgAN progression risk 76% in Phase 3

Two-year ORIGIN 3 data showed atacicept-vymj stabilised kidney function and slashed composite disease progression risk, supporting a full FDA approval filing in Q4
Two-year ORIGIN 3 data showed atacicept-vymj stabilised kidney function and slashed composite disease progression risk, supporting a full FDA approval filing in Q4
Biotech
Bioprocessing

Cannara Biotech expands credit facility to C$80m with BMO and TD

The Québec cannabis producer has upsized its syndicated debt facility by C$30m and extended its maturity to December 2029.
The Québec cannabis producer has upsized its syndicated debt facility by C$30m and extended its maturity to December 2029.
Diagnostics
Pharmaceuticals
Digital Health

Cerenome secures $20m royalty-based facility to scale CNSide platform

The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
Medical Devices
Diagnostics

CooperCompanies retains CooperSurgical and lifts buyback to $3bn

CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
Biologics
Pharmaceuticals

Genelux publishes SCLC case report showing 16.7-month PFS with Olvi-Vec

A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
Medical Devices
Diagnostics

Hexiris Ophthalmics to show OBi glaucoma data at five meetings

Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Pharmaceuticals
Diagnostics

Quantum BioPharma clears FDA IND for PAD2-targeting MS drug Lucid-MS

Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
Biologics
Pharmaceuticals

Immutep refocuses efti on HNSCC and sarcoma after trial failure

Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
Medical Devices
Pharmaceuticals
Digital Health

HOPE Therapeutics first to deploy Zeta Surgical's robotic TMS system

NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
Diagnostics
Genomics
Regulatory Science

Bionano Labs OGM test in line for Medicare coverage under proposed LCD

MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
Medical Devices
Digital Health
Diagnostics

Circle CVI positions cvi42 for TAVR volume surge after CMS ruling

CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
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