Cell & Gene Therapy

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

Taranis Capital and EEC Partner to Build Next-Generation Data Centres

Taranis Capital and Emaar Executive Company partner to develop carrier-neutral data centres across Saudi Arabia, supporting rising AI and cloud demand under Vision 2030

Taranis Capital Limited (“Taranis”), a DFSA-regulated investment firm based in Dubai International Financial Centre (DIFC), has signed a Memorandum of Understanding (MOU) with Emaar Executive Company (EEC) to develop, construct, and operate a portfolio of next-generation, carr

Mark Walker  · 
Cell & Gene Therapy

Cell therapy's second act: why Boston is still winning

Four years after the first wave of CAR-T IPOs, Massachusetts is quietly becoming the centre of gravity for the next generation of cell therapies — this time, for solid tumours.

When the FDA approved the first CAR-T therapy for leukaemia in 2017, the assumption across the industry was that the blood cancer playbook would translate quickly into solid tumours. It did not.

Mark Walker  · 
Cell & Gene Therapy

The Royal Marsden Pioneers CAR-T Therapy for Multiple Myeloma in the UK

During Blood Cancer Awareness Month, The Royal Marsden becomes the first UK centre to treat multiple myeloma patients with CAR-T therapy outside clinical trials

During Blood Cancer Awareness Month, The Royal Marsden becomes the first UK centre to treat multiple myeloma patients with CAR-T therapy outside clinical trials, offering renewed hope and

The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals
Regulatory Science
Biologics

Ultragenyx wins FDA approval for FAYUVI in Sanfilippo syndrome Type A

FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

SNIPR enrolls first Phase 2 patient in CRISPR phage trial

SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Capricor to present 24-month Deramiocel DMD data at WMS 2026

Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Tempest Therapeutics options Senlang lentiviral in vivo CAR-T platform

Tempest secures an exclusive option on Senlang's CD7-targeted lentiviral vector platform, adding a Phase 1 multiple myeloma programme to its in vivo CAR
Tempest secures an exclusive option on Senlang's CD7-targeted lentiviral vector platform, adding a Phase 1 multiple myeloma programme to its in vivo CAR
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
Diagnostics
Bioprocessing
Cell & Gene Therapy

ChemoMetec posts 3% revenue rise as XcytoMatic sales more than double

The Danish cell-counting specialist reported DKK 511m in revenue and a 55% EBITDA margin for 2025/26, with automation demand accelerating instrument sales.
The Danish cell-counting specialist reported DKK 511m in revenue and a 55% EBITDA margin for 2025/26, with automation demand accelerating instrument sales.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Resolution Therapeutics completes enrolment in EMERALD liver trial

All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

Legend Biotech to present five-year CARVYKTI data at IMS 2026

Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

IMUNON signs NCI CRADA to expand IMNN-001 into new solid tumours

IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics
Pharmaceuticals

Opus Genetics reports positive Phase 1/2 OPGx-BEST1 data

All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

Intellia Therapeutics secures $400m debt facility with OrbiMed

The CRISPR biotech drew an initial $75m at closing, with further tranches tied to milestones for its HAE gene-editing candidate lonvo-z.
The CRISPR biotech drew an initial $75m at closing, with further tranches tied to milestones for its HAE gene-editing candidate lonvo-z.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Cell & Gene Therapy

Eledon files IND for islet cell transplant trial as Phase 3 nears

Eledon Pharmaceuticals has submitted an IND for a registrational islet cell transplant study of tegoprubart, while reaffirming its Q4 2026 Phase 3 kidney trial start.
Eledon Pharmaceuticals has submitted an IND for a registrational islet cell transplant study of tegoprubart, while reaffirming its Q4 2026 Phase 3 kidney trial start.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Opus Genetics to unveil OPGx-BEST1 Phase 1/2 data on 9 September

The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Genomics

Scribe Therapeutics IPO raises $155m as STX-1150 enters clinic

The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
The Biotech Times Editorial Team  · 
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