Cell & Gene Therapy

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

Mesoblast completes enrolment in Phase 3 chronic back pain trial

Mesoblast has hit its 300-patient recruitment target for MSB-DR004, with topline data expected mid-2027 ahead of a planned FDA BLA filing.
Mesoblast has hit its 300-patient recruitment target for MSB-DR004, with topline data expected mid-2027 ahead of a planned FDA BLA filing.
The Biotech Times Editorial Team  · 
Bioprocessing
Cell & Gene Therapy

Cabaletta Bio signs 10-year cell therapy supply deal with Cellares

The agreement covers commercial-scale automated manufacture of rese-cel for autoimmune disease, with a BLA submission in myositis planned for 2027.
The agreement covers commercial-scale automated manufacture of rese-cel for autoimmune disease, with a BLA submission in myositis planned for 2027.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals

Tempest Therapeutics to present TPST-2003 CAR-T data at ISCT 2026

Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
The Biotech Times Editorial Team  · 
Pharmaceuticals
Cell & Gene Therapy

Regeneron Q1 2026 revenues rise 19% on Dupixent and new approvals

Regeneron posted $3.6bn in Q1 revenues and secured three FDA approvals, including the first gene therapy for genetic hearing loss.
Regeneron posted $3.6bn in Q1 revenues and secured three FDA approvals, including the first gene therapy for genetic hearing loss.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Regulatory Science

Orchard Therapeutics wins Innovation Passport for OTL-201 in MPS-IIIA

OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Regulatory Science

Creative Medical claims 93% response rate in Ultrasome knee OA pilot

CELZ reported its cell-free Ultrasome therapy met its primary endpoint in a knee osteoarthritis pilot, with no serious adverse events observed.
CELZ reported its cell-free Ultrasome therapy met its primary endpoint in a knee osteoarthritis pilot, with no serious adverse events observed.
The Biotech Times Editorial Team  · 
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