Research

Cell & Gene Therapy
Biologics

Opus Genetics to unveil OPGx-BEST1 Phase 1/2 data on 9 September

The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
Medical Devices
Diagnostics

AiM Medical Robotics wins $2m NCI grant for MRI brain robot

The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
Diagnostics
Pharmaceuticals

Telix completes BiPASS enrolment and aligns with FDA on NDA path

Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Biologics

Medera SRD-002 gene therapy hits 12-month HFpEF endpoints

Twelve-month Phase 1/2a data showed 80% of patients normalised cardiac filling pressures after a single dose of the SERCA2a gene therapy.
Twelve-month Phase 1/2a data showed 80% of patients normalised cardiac filling pressures after a single dose of the SERCA2a gene therapy.
Regulatory Science

Artelo Biosciences wins US patent allowance for ART27.13 formulation

The Nasdaq-listed biotech secured IP protection for its cannabinoid agonist's commercial formulation, extending coverage to 2041 across two active Phase 2 studies.
The Nasdaq-listed biotech secured IP protection for its cannabinoid agonist's commercial formulation, extending coverage to 2041 across two active Phase 2 studies.
Biologics
Diagnostics

Acoramidis shows structural cardiac reversal in 54-month ATTR-CM data

BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
Bioprocessing

PharmAla secures MDMA patent and hires Canaccord as banking partner

PharmAla Biotech has been granted a US process patent for enantioselective MDMA production and pulled its APA-01 licensing deal with Restora Neurosciences.
PharmAla Biotech has been granted a US process patent for enantioselective MDMA production and pulled its APA-01 licensing deal with Restora Neurosciences.
Biologics

Insulinova partners San Raffaele to test encapsulated beta cells

Insulinova will fund OSR-led research combining stem cell-derived beta cells with Austrianova's Cell-in-a-Box encapsulation platform to pursue immunosuppression-free
Insulinova will fund OSR-led research combining stem cell-derived beta cells with Austrianova's Cell-in-a-Box encapsulation platform to pursue immunosuppression-free
Biologics

AskBio presents GenePHIT Phase 2 baseline data at ESC 2026

AskBio's umiposgene parvec heart failure gene therapy trial enrolled over 170 patients across 64 sites; efficacy data are expected in H1 2027.
AskBio's umiposgene parvec heart failure gene therapy trial enrolled over 170 patients across 64 sites; efficacy data are expected in H1 2027.
Biologics

Roche Vabysmo shows sustained two-year data in PCV subtype of nAMD

Two-year SALWEEN results show faricimab cleared polypoidal lesions in most patients and extended dosing intervals to 20 weeks in 61% by year two.
Two-year SALWEEN results show faricimab cleared polypoidal lesions in most patients and extended dosing intervals to 20 weeks in 61% by year two.
Biologics

Amarin REDUCE-IT legacy analysis suggests durable CV benefit after IPE

A post hoc analysis of REDUCE-IT, presented at ESC 2026, suggests icosapent ethyl's cardiovascular benefit may persist years after treatment stops in adherent
A post hoc analysis of REDUCE-IT, presented at ESC 2026, suggests icosapent ethyl's cardiovascular benefit may persist years after treatment stops in adherent
Biologics
Biotech

Eascra Biotech wins $7.96m NASA contract for space-made nanomedicine

The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
Digital Health

BrainsWay Deep TMS data show 70% cut in suicidal ideation in MDD

A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
Biologics

CytomX wins FDA Fast Track for EpCAM ADC in metastatic colorectal cancer

The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
Diagnostics

BridgeBio doses first patient in ASCEND-ATTR Phase 3b/4 study

BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
Digital Health
Biologics

Johns Hopkins wins NIH R01 to study GLP-1 long-term value

A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
Digital Health
Bioinformatics

Philips wins $33.7m ARPA-H award for AI robotic stroke care

Philips will work with Johns Hopkins and Boston University to develop remote and automated endovascular stroke procedures under the ARPA-H AIR programme.
Philips will work with Johns Hopkins and Boston University to develop remote and automated endovascular stroke procedures under the ARPA-H AIR programme.
Biologics

Mesoblast posts US$120m revenue as RYONCIL ramps

Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
Biologics

Monte Rosa doses first patient in Phase 2 MRT-2359 prostate cancer study

Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
Diagnostics

RenovoRx publishes PK/PD data showing 51% tumour-site drug extraction

Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
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