Regulatory Science

Cytokinetics' aficamten hits dual Phase 3 endpoints in nHCM

ACACIA-HCM met both primary endpoints — symptom burden and exercise capacity — marking the first positive Phase 3 trial in non-obstructive HCM.
ACACIA-HCM met both primary endpoints — symptom burden and exercise capacity — marking the first positive Phase 3 trial in non-obstructive HCM.
Regulatory Science

Dupixent shows esophageal function gains in Phase 4 EoE trial

Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Pharmaceuticals
Biotech

Electra Therapeutics doses first patient in ipsoprubart T cell trial

Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Cell & Gene Therapy

Ernexa's ERNA-101 clears tumours completely in ovarian cancer models

Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
Diagnostics

Eupraxia EoE drug shows >90% inflammation cut in Phase 1b/2a data

EP-104GI reduced EoEHSS inflammation scores by more than 90% at the highest dose tested, with fibrosis improvements sustained to 36 weeks.
EP-104GI reduced EoEHSS inflammation scores by more than 90% at the highest dose tested, with fibrosis improvements sustained to 36 weeks.
Diagnostics
Regulatory Science

EyePoint targets mid-2026 wet AMD readout as losses widen

EyePoint said its DURAVYU Phase 3 wet AMD trials remain on track for topline data from mid-2026, backed by $223m in cash extending into
EyePoint said its DURAVYU Phase 3 wet AMD trials remain on track for topline data from mid-2026, backed by $223m in cash extending into
Diagnostics

Femasys logs first commercial use of FemaSeed Complete in OB/GYN offices

Femasys says its integrated intratubal insemination system has achieved its first revenue-generating use, positioning OB/GYNs as first-line fertility providers.
Femasys says its integrated intratubal insemination system has achieved its first revenue-generating use, positioning OB/GYNs as first-line fertility providers.
Diagnostics

Glucotrack CBGM hits 6.8% MARD over 240 days in ovine study

A peer-reviewed ovine study shows Glucotrack's implantable glucose monitor maintained accuracy for up to 240 days with no device-related adverse events.
A peer-reviewed ovine study shows Glucotrack's implantable glucose monitor maintained accuracy for up to 240 days with no device-related adverse events.
Bioprocessing
Diagnostics

ChemoMetec Q3 revenue rises 15% as XcytoMatic platform gains traction

The Danish cell-counting specialist reported DKK 142.3m in Q3 revenue, with XcytoMatic instrument sales quadrupling year-on-year, excluding a one-off accounting
The Danish cell-counting specialist reported DKK 142.3m in Q3 revenue, with XcytoMatic instrument sales quadrupling year-on-year, excluding a one-off accounting
Biotech

Hemab Therapeutics prices upsized IPO at $18 per share on Nasdaq

The coagulation-disorder biotech raised approximately $301.5m gross, listing under ticker COAG with two clinical-stage antibody programmes in its pipeline.
The coagulation-disorder biotech raised approximately $301.5m gross, listing under ticker COAG with two clinical-stage antibody programmes in its pipeline.
Regulatory Science

Immunocore posts $107m KIMMTRAK quarter with landmark five-year OS data

KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
Cell & Gene Therapy

IN8bio to present GBM clinical data and TCE platform at ASCO and R&D Day

IN8bio will showcase its gamma-delta T cell engager platform and new glioblastoma clinical data across four conferences in May and June 2026.
IN8bio will showcase its gamma-delta T cell engager platform and new glioblastoma clinical data across four conferences in May and June 2026.
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