Clinical Trials

Pharmaceuticals
Diagnostics
Cell & Gene Therapy

KORTUC hits 184-patient enrolment in registrational breast cancer trial

The Palo Alto radiosensitizer biotech said its UK-led breast cancer study is now moving toward a 2027 efficacy readout, as two further cancer trials
The Palo Alto radiosensitizer biotech said its UK-led breast cancer study is now moving toward a 2027 efficacy readout, as two further cancer trials
Biologics
Pharmaceuticals

One04 Therapeutics launches on Phase 1 data for Factor H candidate

The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
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
Pharmaceuticals
Diagnostics

Agomab reports positive Phase 1 data for inhaled IPF drug AGMB-447

Agomab's lung-restricted ALK5 inhibitor showed favourable safety and proof-of-mechanism in IPF patients; a Phase 2 study is set to begin before
Agomab's lung-restricted ALK5 inhibitor showed favourable safety and proof-of-mechanism in IPF patients; a Phase 2 study is set to begin before
Diagnostics
Pharmaceuticals
Biologics

Telix's Pixclara wins FDA approval as first glioma FET-PET agent

Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.
Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.
Biologics
Pharmaceuticals

Immunocore completes TEBE-AM enrolment as tebentafusp Phase 3 matures

Immunocore has enrolled 540 patients in its registrational TEBE-AM trial, with topline overall survival data expected as early as end of 2026.
Immunocore has enrolled 540 patients in its registrational TEBE-AM trial, with topline overall survival data expected as early as end of 2026.
Biologics
Pharmaceuticals

J&J's amivantamab plus chemo hits 34-month OS in EGFR Ex20ins NSCLC

Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to
Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to
Pharmaceuticals
Regulatory Science

Leios Therapeutics clears FDA end-of-phase 2 meeting for 10XB-101

The La Jolla biotech secured FDA alignment on Phase 3 design for its injectable submental fat treatment, clearing the path to a 505(b)(2
The La Jolla biotech secured FDA alignment on Phase 3 design for its injectable submental fat treatment, clearing the path to a 505(b)(2
Medical Devices

Elixir Medical wins Japan approval for DynamX coronary bioadaptor

Japan's MHLW has approved Elixir Medical's DynamX bioadaptor for coronary artery disease, creating a new device category in the country.
Japan's MHLW has approved Elixir Medical's DynamX bioadaptor for coronary artery disease, creating a new device category in the country.
Pharmaceuticals
Regulatory Science

Pharmazz wins FDA Orphan Drug Designation for sovateltide in NHIE

Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
Biologics
Pharmaceuticals

Revelyx Bio Phase 2 data back recombinant liquid botulinum toxin YY003

YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
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.
Biologics
Pharmaceuticals

Leads Biolabs opamtistomig hits 87% ORR in squamous NSCLC at WCLC

Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
Biologics
Pharmaceuticals

Oncolytics reports pelareorep active alongside pan-RAS inhibitor in CRC

Preclinical data show pelareorep maintained tumour-reducing activity when combined with a pan-RAS inhibitor, with no evidence of antagonism between the two agents.
Preclinical data show pelareorep maintained tumour-reducing activity when combined with a pan-RAS inhibitor, with no evidence of antagonism between the two agents.
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.
Medical Devices

SS Innovations reports 14,000+ procedures and telesurgery record

SS Innovations says its SSi Mantra system has surpassed 14,100 cumulative procedures and set a new longest-distance telesurgery record spanning 13,600 miles.
SS Innovations says its SSi Mantra system has surpassed 14,100 cumulative procedures and set a new longest-distance telesurgery record spanning 13,600 miles.
Digital Health
Regulatory Science

Sequoia Project, AHIMA and HCPro launch information blocking training

The three organisations have released a four-course online series to help healthcare workforces comply with US federal information blocking rules now under active
The three organisations have released a four-course online series to help healthcare workforces comply with US federal information blocking rules now under active
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.
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