Clinical Trials

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
Pharmaceuticals
Biologics

Rhythm Pharma setmelanotide shows BMI gains in paediatric HO data

Real-world French data and Phase 3 post-hoc analyses reinforce setmelanotide's cardiometabolic benefits in paediatric acquired hypothalamic obesity.
Real-world French data and Phase 3 post-hoc analyses reinforce setmelanotide's cardiometabolic benefits in paediatric acquired hypothalamic obesity.
Biologics
Pharmaceuticals

Tam-Peli cuts SCLC death risk 54% in Phase III, Roche reports

MediLink's B7-H3 ADC beat topotecan on overall survival and response rate in 451-patient Chinese trial, with an NDA now accepted by China
MediLink's B7-H3 ADC beat topotecan on overall survival and response rate in 451-patient Chinese trial, with an NDA now accepted by China
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.
Pharmaceuticals
Genomics
Regulatory Science

CAMP4 Therapeutics wins MHRA nod for CMP-002 SYNGAP1 Phase 1/2 trial

CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related
CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related
Biologics
Pharmaceuticals

Electra Therapeutics starts Phase 1 of SIRPγ antibody ELA822

Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Pharmaceuticals
Biologics

Pharming wins FDA approval for Joenja in children aged 4 to 11 with APDS

The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
Genomics
Diagnostics
Regulatory Science

NAD recommends Nucleus Genomics modify embryo screening ad claims

The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
Medical Devices

Intuitive meta-analysis backs da Vinci across 13 conditions

A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
Pharmaceuticals
Regulatory Science

Nicox NCX 470 NDA accepted for review by China's NMPA

China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
Cell & Gene Therapy
Biologics
Regulatory Science

Resolution Therapeutics completes enrolment in EMERALD liver trial

All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
Biologics
Pharmaceuticals
Medical Devices

Syncromune presents SYNC-T Phase 1 prostate data at CIRSE 2026

The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
Pharmaceuticals
Biologics

Teitur Trophics reports Phase I safety and CNS exposure for TT-P34

The Danish biotech said its Parkinson's peptide TT-P34 was well tolerated and crossed the blood-brain barrier, with biomarker signals supporting lysosomal pathway
The Danish biotech said its Parkinson's peptide TT-P34 was well tolerated and crossed the blood-brain barrier, with biomarker signals supporting lysosomal pathway
Pharmaceuticals
Regulatory Science

Adneuris presents Phase 3 and abuse-potential data for cebranopadol

Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Biologics
Medical Devices
Regulatory Science

Biora Therapeutics to start first human trial of oral biologic capsule

The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
Pharmaceuticals
Diagnostics

CervoMed neflamapimod nfvPPA biomarker data accepted at ISFTD 2026

CervoMed will present 12-week plasma biomarker data from its Phase 2a nfvPPA trial at ISFTD in October, covering at least 22 participants.
CervoMed will present 12-week plasma biomarker data from its Phase 2a nfvPPA trial at ISFTD in October, covering at least 22 participants.
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