Regulatory Science

Bioxodes reports positive Phase 2a data for BIOX-101 in ICH

Bioxodes presented final BIRCH trial data at ESOC 2026, showing BIOX-101 reduced haemorrhage volume and edema growth with no mortality in 23 ICH patients.
Bioxodes presented final BIRCH trial data at ESOC 2026, showing BIOX-101 reduced haemorrhage volume and edema growth with no mortality in 23 ICH patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals

BriaCell wins FDA clearance for Bria-BRES+ breast cancer IND

BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
The Biotech Times Editorial Team  · 
Regulatory Science

CDT Equity advances AZD5904 to PCT stage and seeks pharma partner

CDT Equity has filed for PCT patent protection on its myeloperoxidase inhibitor AZD5904 and is now actively seeking an out-licensing partner for late-stage
CDT Equity has filed for PCT patent protection on its myeloperoxidase inhibitor AZD5904 and is now actively seeking an out-licensing partner for late-stage
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science

Cellectar's iopofosine I 131 shows durable WM responses at 12 months

Phase 2b CLOVER WaM data show 83.6% ORR and 17.8-month median response duration, strengthening the case for accelerated FDA approval.
Phase 2b CLOVER WaM data show 83.6% ORR and 17.8-month median response duration, strengthening the case for accelerated FDA approval.
The Biotech Times Editorial Team  · 
Regulatory Science

Cristcot names Rayna Herman to lead HCA commercial division

Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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