Cell & Gene Therapy

Cell-based and gene-based therapeutics, including CAR-T, stem-cell therapies, and gene editing.
Cell & Gene Therapy
Biologics

Currus Biologics wins FDA IND clearance for CUR-001 CAR-T trial

The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
Cell & Gene Therapy
Biologics

4DMT enrols first patients in 4SIGHT Phase 3 DME gene therapy trial

4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen's OCU400 gains provisional approval in The Bahamas for RP

Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Medical Devices
Diagnostics
Pharmaceuticals
Cell & Gene Therapy
Biologics

Penn Medicine and IBA form Noventra Oncology Alliance JV

The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova present Klothonova encapsulated-cell data

The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
Cell & Gene Therapy
Biologics

CIRM awards $9m to Enloe Health for Northern California CGT centre

The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
Cell & Gene Therapy
Biologics

Celularity closes $10m first tranche of $28m recapitalisation

Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
Pharmaceuticals
Biologics
Cell & Gene Therapy

C4 Therapeutics cemsidomide shows T-cell data at IMS 2026

Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Cell & Gene Therapy
Biologics

CARVYKTI: half of earlier-line myeloma patients free at five years

Five-year CARTITUDE-2 data show 50% of RRMM patients remained alive and progression-free after a single cilta-cel infusion, with overall survival at
Five-year CARTITUDE-2 data show 50% of RRMM patients remained alive and progression-free after a single cilta-cel infusion, with overall survival at
Diagnostics
Biologics
Cell & Gene Therapy

Adaptive Biotechnologies cites clonoSEQ in new myeloma cure definition

A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
Cell & Gene Therapy
Biologics
Pharmaceuticals

CARVYKTI gives five-year remissions to 50% in early-line myeloma

Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
Biologics
Cell & Gene Therapy
Pharmaceuticals

Transgene reports 100% DFS at 41 months for TG4050 HNSCC vaccine

Transgene's personalised neoantigen vaccine TG4050 maintained 100% disease-free survival at over three years in resected head and neck cancer, with Phase 2 topline
Transgene's personalised neoantigen vaccine TG4050 maintained 100% disease-free survival at over three years in resected head and neck cancer, with Phase 2 topline
Cell & Gene Therapy
Pharmaceuticals

Ligand commits up to $47m to back AvenCell's allogeneic CAR-T pipeline

Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
Cell & Gene Therapy
Genomics

Prime Medicine wins FDA IND clearance for PM647 in AATD

The Cambridge biotech's in vivo Prime Editor targets the root genetic cause of alpha-1 antitrypsin deficiency, with first-in-human data expected in
The Cambridge biotech's in vivo Prime Editor targets the root genetic cause of alpha-1 antitrypsin deficiency, with first-in-human data expected in
Biologics
Synthetic Biology
Cell & Gene Therapy

Scarlet Therapeutics wins $14m DARPA deal for smart red blood cells

The Bristol biotech will lead an international consortium to engineer red blood cells that sense and respond to physiological changes.
The Bristol biotech will lead an international consortium to engineer red blood cells that sense and respond to physiological changes.
Biologics
Cell & Gene Therapy

Adagene wins NMPA IND clearance for masked HER2xCD3 bispecific ADG138

Adagene's double-masked T-cell engager ADG138 cleared China's NMPA for a Phase 1 solid tumour trial due to start in Q4 2026.
Adagene's double-masked T-cell engager ADG138 cleared China's NMPA for a Phase 1 solid tumour trial due to start in Q4 2026.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Vironexis VNX-101 achieves MRD-negative responses in R/R ALL

All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
Cell & Gene Therapy
Bioprocessing
Biologics

Avaí Bio clears cell bank safety testing for Klotho therapy

Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
Cell & Gene Therapy
Pharmaceuticals

Longeveron HLHS stem cell trial misses primary endpoint

ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
Biologics
Cell & Gene Therapy
Diagnostics
Genomics

NCCN guidelines name clonoSEQ for myeloma MRD testing

Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
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