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Ultragenyx sells priority review voucher for $210M
Ultragenyx received the PRV from the FDA's August 2026 approval of Genglycos, the first treatment designed to address the underlying cause of glycogen storage disease type Ia.
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Capricor shares 24-month data for Duchenne therapy
Capricor is relying on the 24-month data to support its amended BLA, which faces a November 22 FDA decision.
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SereNeuro secures pre-seed financing to advance iPSC-derived pain therapy
SN101 is an off-the-shelf, non-opioid therapy made of purified human pain-sensing neurons derived from induced pluripotent stem cells.
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Charles River, Autolomous partner to digitize lab execution
The companies announced the launch of Apollo Orchestrate, a new capability within Charles River's Apollo platform built on Autolomous' autoloMATE laboratory execution system.
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Beam sues Chinese startup, alleging theft of trade secrets
Beam has filed a lawsuit alleging that former scientist stole confidential base-editing research to cofound a rival biotech.
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Pierre Fabre resubmits BLA for twice-rejected T-cell therapy
Tabelecleucel is an allogeneic T-cell therapy with a proposed indication for relapsed/refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
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uniQure gene therapy slows Huntington's progression, but investors aren't convinced
Additional data from the ongoing phase 1/2 studies of AMT-130 show a 44% slowing of Huntington's disease progression compared with an external control.
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Adicet off-the-shelf CAR-T shows early signs of efficacy in lupus
At the 12-month mark, 50% of evaluable lupus nephritis patients achieved a complete renal response and 54% of evaluable patients achieved DORIS remission.
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Kyverna touts one-year durability data for autoimmune CAR-T
Kyverna intends to include the one-year data in its rolling BLA submission, on track to be completed in Q4 2026.
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Cellares partners with Seoul hospital to automate gene-edited HSPC therapy manufacturing
The partnership marks Cellares' second collaboration in Asia.
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