Clinical Trials

Imviva Biotech CTD402 shows 80–86% response in R/R T-ALL at EHA2026

Allogeneic anti-CD7 CAR-T candidate CTD402 posted strong remission rates in adult and paediatric T-cell leukaemia patients across two EHA2026 poster presentations.
Allogeneic anti-CD7 CAR-T candidate CTD402 posted strong remission rates in adult and paediatric T-cell leukaemia patients across two EHA2026 poster presentations.
The Biotech Times Editorial Team  · 
Genomics

Kyntra Bio roxadustat shows TI benefit in LR-MDS regardless of RS status

Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.
Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.
The Biotech Times Editorial Team  · 

Lyell Immunopharma reports ronde-cel safety data at EHA 2026

Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.
Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis Rhapsido meets Phase 3 endpoints across three CIndU subtypes

RemIND trial data presented at EAACI 2026 show remibrutinib doubled complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic
RemIND trial data presented at EAACI 2026 show remibrutinib doubled complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic
The Biotech Times Editorial Team  · 
Regulatory Science

Sanofi wins FDA approval for Tzield in stage 3 type 1 diabetes

The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.
The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.
The Biotech Times Editorial Team  · 
Regulatory Science

Rafael Holdings completes Phase 3 NPC trial, targets NDA in H2 2026

Rafael Holdings hit last-patient-last-visit in its pivotal TransportNPC trial and expects to file an NDA for Trappsol Cyclo in the second half
Rafael Holdings hit last-patient-last-visit in its pivotal TransportNPC trial and expects to file an NDA for Trappsol Cyclo in the second half
The Biotech Times Editorial Team  · 
Diagnostics

Roche gains FDA nod for first PTEN companion diagnostic

The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
The Biotech Times Editorial Team  · 
Diagnostics

Syndax revumenib shows broad activity across leukaemia studies at EHA

Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.
Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.
The Biotech Times Editorial Team  · 
Regulatory Science

Ascendis Pharma reports five-year Phase 2 data for TransCon PTH

Palopegteriparatide sustained multi-organ benefits over five years in hypoparathyroidism, with 82% of patients meeting the multi-component response endpoint.
Palopegteriparatide sustained multi-organ benefits over five years in hypoparathyroidism, with 82% of patients meeting the multi-component response endpoint.
The Biotech Times Editorial Team  · 
Diagnostics

Caribou Biosciences CB-011 shows 83% CR rate in r/r myeloma at EHA

Updated CaMMouflage phase 1 data show deep, durable responses from a single dose in heavily pretreated, BCMA-naïve multiple myeloma patients.
Updated CaMMouflage phase 1 data show deep, durable responses from a single dose in heavily pretreated, BCMA-naïve multiple myeloma patients.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Climb Bio posts Phase 1b ITP data for budoprutug at EHA 2026

Early data from 15 heavily pretreated patients show robust B-cell depletion and durable platelet responses, with no serious adverse events reported.
Early data from 15 heavily pretreated patients show robust B-cell depletion and durable platelet responses, with no serious adverse events reported.
The Biotech Times Editorial Team  · 
Diagnostics

Roche's Tecentriq wins FDA Priority Review in stage III colon cancer

The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

HUTCHMED sovleplenib hits Phase III primary endpoint in wAIHA

ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
The Biotech Times Editorial Team  · 
Biotech

Immuneering doses first patient in Phase 3 pancreatic cancer trial

The MAPKeeper 301 trial will test atebimetinib plus modified chemotherapy in first-line metastatic PDAC, with topline overall survival data expected in mid-2028.
The MAPKeeper 301 trial will test atebimetinib plus modified chemotherapy in first-line metastatic PDAC, with topline overall survival data expected in mid-2028.
The Biotech Times Editorial Team  · 
Diagnostics

Kura and Kyowa Kirin report 94% 12-month survival in AML combo trial

KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
The Biotech Times Editorial Team  · 
Genomics

Novartis del-brax Phase I/II FSHD study meets primary biomarker endpoint

Novartis says its AOC therapy del-brax hit biomarker endpoints in the FORTITUDE study, with Phase III now enrolling 200 FSHD patients.
Novartis says its AOC therapy del-brax hit biomarker endpoints in the FORTITUDE study, with Phase III now enrolling 200 FSHD patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The Biotech Times Editorial Team  · 
Bioinformatics

Nurix BTK degrader bexobrutideg shows 92.9% ORR in second-line CLL

Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
The Biotech Times Editorial Team  · 
Bioinformatics

Syndax SAVE trial data published in JCO showing 88% ORR

Phase 1/2 SAVE data show revumenib plus decitabine/cedazuridine and venetoclax achieved 88% ORR in heavily pretreated AML patients.
Phase 1/2 SAVE data show revumenib plus decitabine/cedazuridine and venetoclax achieved 88% ORR in heavily pretreated AML patients.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Cartesian licenses mRNA payload to WestGene for in vivo CAR-T

Cartesian Therapeutics and WestGene Biopharma will combine mRNA CAR-T payloads with targeted LNPs to run a Phase 1 MG trial from late 2026.
Cartesian Therapeutics and WestGene Biopharma will combine mRNA CAR-T payloads with targeted LNPs to run a Phase 1 MG trial from late 2026.
The Biotech Times Editorial Team  · 
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