Disease

Cell & Gene Therapy
Genomics

Tenaya wins FDA RMAT designation for ARVC gene therapy TN-401

Tenaya Therapeutics has secured RMAT designation for TN-401, its AAV9-based gene therapy for PKP2-associated ARVC, backed by Phase 1b/2 interim data.
Tenaya Therapeutics has secured RMAT designation for TN-401, its AAV9-based gene therapy for PKP2-associated ARVC, backed by Phase 1b/2 interim data.
Diagnostics
Genomics

Veracyte acquires Convergent Genomics for up to $180m

Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.
Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.
Medical Devices
Diagnostics

Femasys partners CapexMD to finance FemaSeed fertility access

Femasys has linked with specialist fertility lender CapexMD to offer patients financing for its FemaSeed intratubal insemination portfolio across OB/GYN practices.
Femasys has linked with specialist fertility lender CapexMD to offer patients financing for its FemaSeed intratubal insemination portfolio across OB/GYN practices.
Pharmaceuticals
Diagnostics

Persica bolsters PP353 rationale with disc microbiology review

A new methodological scoping review by Persica Pharmaceuticals argues that low assay sensitivity explains conflicting findings on bacterial presence in spinal discs.
A new methodological scoping review by Persica Pharmaceuticals argues that low assay sensitivity explains conflicting findings on bacterial presence in spinal discs.
Pharmaceuticals

Verrica to present YCANTH and VP-315 data at two dermatology meetings

Post-hoc Phase 3 data show YCANTH cleared molluscum in over half of long-duration patients, while VP-315 showed abscopal-like activity in untreated
Post-hoc Phase 3 data show YCANTH cleared molluscum in over half of long-duration patients, while VP-315 showed abscopal-like activity in untreated
Pharmaceuticals
Diagnostics

Galimedix to present eDREAM Phase 2 GA data at EURETINA 2026

Galimedix Therapeutics will present five abstracts from its Phase 2 eDREAM study of GAL-101 in geographic atrophy at the Vienna congress in October.
Galimedix Therapeutics will present five abstracts from its Phase 2 eDREAM study of GAL-101 in geographic atrophy at the Vienna congress in October.
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
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.
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.
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
AgriTech
Diagnostics

Rad Source launches Sterile Insect Farms division for mosquito control

Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
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.
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
Medical Devices

Health Textiles Nigeria begins PermaNet Dual net production

Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
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.
Subscribe to Disease