North America

The United States and Canada.
Pharmaceuticals
Biologics

Caspian Therapeutics launches with $50m to target diabetes

Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Cell & Gene Therapy
Genomics
Pharmaceuticals

Opus Genetics reports positive Phase 1/2 OPGx-BEST1 data

All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
Pharmaceuticals
Regulatory Science

BridgeBio PROPEL 3 data show infigratinib cuts ear infections

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Pharmaceuticals
Biologics

Sobi wins FDA Fast Track for pacritinib in VEXAS syndrome

The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
Biologics
Pharmaceuticals

Solstice Oncology launches with $225m Series A for CTLA-4 antibody

The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
Biologics
Pharmaceuticals

SOTIO doses first patient in CDH17-targeting ADC trial for CRC

SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
Biologics
Regulatory Science

Roche wins FDA Priority Review for Enspryng in MOGAD

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
Pharmaceuticals
Biologics

AirNexis AN01 meets primary endpoint in Phase 2b COPD study

Dual PDE3/4 inhibitor AN01 improved lung function versus placebo in COPD patients already on bronchodilator therapy, with data presented at ERS 2026.
Dual PDE3/4 inhibitor AN01 improved lung function versus placebo in COPD patients already on bronchodilator therapy, with data presented at ERS 2026.
Pharmaceuticals
Biologics

Assembly Bio exercises Gilead profit-share option for HSV drug programme

Assembly Biosciences will take a 40% share of US costs and profits for the GS-1179 helicase-primase inhibitor as a Phase 2 trial approaches.
Assembly Biosciences will take a 40% share of US costs and profits for the GS-1179 helicase-primase inhibitor as a Phase 2 trial approaches.
Pharmaceuticals
Biologics

Dyne Therapeutics to share one-year ACHIEVE DM1 data at WMS and AANEM

Dyne will present pooled Phase 1/2 data for z-basivarsen against a matched natural history cohort, with registrational topline results due Q1 2027.
Dyne will present pooled Phase 1/2 data for z-basivarsen against a matched natural history cohort, with registrational topline results due Q1 2027.
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
Biologics
Pharmaceuticals

Vor Bio completes UPSTREAM MG enrolment and launches oMG trial

Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Pharmaceuticals
Regulatory Science

Aprea Therapeutics expands patent estate for WEE1 and ATR programmes

The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.
The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.
Medical Devices
Diagnostics

BTT Medical opens first-in-human trial of fever-induction device

BTT Medical Institute has launched a safety trial of its brain-guided hyperthermia system, citing a single ALS case report as the basis for development.
BTT Medical Institute has launched a safety trial of its brain-guided hyperthermia system, citing a single ALS case report as the basis for development.
Biologics
Pharmaceuticals

NorthStrive files patents for EL-22 and EL-32 in spaceflight muscle loss

NorthStrive Biosciences has filed two US patent applications extending its myostatin-targeting probiotic candidates into microgravity-induced muscle atrophy.
NorthStrive Biosciences has filed two US patent applications extending its myostatin-targeting probiotic candidates into microgravity-induced muscle atrophy.
Medical Devices

Nyxoah enrols first patient in BREATHE post-approval OSA study

The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA
The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA
Pharmaceuticals

Teva launches senior notes offering to refinance existing debt

Teva Pharmaceutical is issuing EUR and USD senior notes via Dutch finance subsidiaries, with proceeds earmarked primarily for early redemption of existing notes.
Teva Pharmaceutical is issuing EUR and USD senior notes via Dutch finance subsidiaries, with proceeds earmarked primarily for early redemption of existing notes.
Genomics

OCEARCH genomics study finds sibling pairs among white sharks

A landmark DNA study of Western North Atlantic white sharks has identified three full sibling pairs and seven likely half-sibling pairs, challenging the species'
A landmark DNA study of Western North Atlantic white sharks has identified three full sibling pairs and seven likely half-sibling pairs, challenging the species'
Pharmaceuticals
Diagnostics

Zentalis Pharmaceuticals launches share offering for azenosertib

Zentalis is raising fresh capital via an underwritten public offering to fund trials and pre-commercial activities for its WEE1 inhibitor azenosertib in ovarian cancer.
Zentalis is raising fresh capital via an underwritten public offering to fund trials and pre-commercial activities for its WEE1 inhibitor azenosertib in ovarian cancer.
Medical Devices
Diagnostics

American Shared Hospital Services Q2 revenue rises 19% to $8.4m

AMS posted 19% year-on-year Q2 revenue growth to $8.4m, led by a 40% surge in direct patient services across its US and
AMS posted 19% year-on-year Q2 revenue growth to $8.4m, led by a 40% surge in direct patient services across its US and
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