CAR-T Setbacks, FDA Momentum and Gene Therapy Investment – Weekly News Round-up

This week’s developments across the advanced therapies sector showcase the continued momentum behind next-generation cell and gene therapies, while also highlighting the strategic realities shaping the market. From new FDA clearances and major financing rounds to pipeline reprioritisation. Companies across the industry are sharpening their focus on differentiated technologies, scalable development strategies and areas of highest unmet need.

11 May 2026
| Rori Mwansa
CAR-T Setbacks, FDA Momentum and Gene Therapy Investment – Weekly News Round-up

Johnson & Johnson discontinues CAR-T lymphoma programmes despite promising efficacy signals

Johnson & Johnson has discontinued development of its CD20-targeting and dual CD19/CD20 CAR-T programmes for large B-cell lymphoma, despite previously highlighting encouraging efficacy data. The decision comes as the company reassesses its oncology strategy and prioritises programmes with clearer commercial and clinical differentiation. The decision underscores the increasingly difficult commercial environment facing CAR-T developers in crowded indications such as large B-cell lymphoma. Strong efficacy alone is no longer enough, companies must also demonstrate meaningful differentiation in safety, manufacturing scalability, durability and market access potential. The news also reflects a broader industry trend toward portfolio prioritisation, with companies becoming more selective about where they deploy capital amid ongoing market pressures.

Read more via Fierce Biotech and Pharma Now

 

Latus Bio raises $97m Series A to advance gene therapies for Huntington’s disease

Emerging gene therapy company Latus Bio has closed a substantial $97 million Series A financing round to support development of gene therapies targeting Huntington’s disease and other neurological disorders. The company is developing AAV-based therapies designed to improve delivery efficiency and durability in the central nervous system. While the gene therapy sector has faced setbacks around manufacturing challenges, regulatory scrutiny and commercial sustainability, significant funding rounds like this suggest confidence remains in next-generation approaches with stronger delivery technologies and clearer translational potential.

Read more via Biopharma Dive

 

Cellenkos secures FDA clearance for CK0802 trial in steroid-refractory GVHD

 Clinical-stage biotech Cellenkos has received FDA clearance for its Investigational New Drug (IND) application to begin a Phase 1b/2a clinical trial of CK0802 in patients with steroid-refractory graft-versus-host disease (GVHD). CK0802 is an allogeneic, off-the-shelf regulatory T-cell (Treg) therapy designed to reduce inflammation and restore immune balance in patients with severe immune complications following stem cell transplantation. The FDA clearance reinforces increasing industry confidence in regulatory T-cell therapies as a promising modality for autoimmune and inflammatory conditions. Off-the-shelf Treg therapies could offer important advantages over personalised cell therapies, including reduced manufacturing complexity, improved scalability and faster patient access. The move also highlights the growing diversification of the cell therapy landscape, with innovation expanding well beyond oncology into immune-mediated diseases and transplant complications.

Read more via BioSpace

Topics
  • Gene Therapy
  • Cell Therapy
  • Rare Disease
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