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BioWorld - Friday, July 17, 2026
Home » Topics » Drugs » Cell therapy

Cell therapy
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Bladder phase II sinks Protara, LMs phase III wins for Palvella

Feb. 24, 2026
By Randy Osborne
No Comments
Almost three months to the day after Protara Therapeutics Inc. made known positive interim data from the phase II trial testing cell-based therapy TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), Palvella Therapeutics Inc. scored positive top-line results from the phase III Selva study evaluating Qtorin 3.9% rapamycin anhydrous gel for microcystic LMs.
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Stem cells

Japan endorses two iPSC drugs for approval under CEA pathway

Feb. 24, 2026
By Marian (YoonJee) Chu
No Comments
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
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Acquisition puzzle

Gilead brings Arcellx fully under the fold for $7.8B

Feb. 23, 2026
By Brian Orelli
No Comments
Gilead Sciences Inc. is acquiring partner Arcellx Inc. at a value of up to $7.8 billion, consisting of $115 per share up front and a potential payment of $5 per share through a contingent value right.
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T cells
Immuno-oncology

Zelluna’s ZI-MA4-1 gains UK CTA clearance for solid tumors

Feb. 23, 2026
No Comments
Zelluna ASA has received approvals from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and research ethics committee for its clinical trial application (CTA) for ZI-MA4-1, Zelluna’s lead T-cell receptor-based natural killer (TCR-NK) product candidate.
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Stem cells

Japan endorses two iPSC drugs for approval under CEA pathway

Feb. 20, 2026
By Marian (YoonJee) Chu
No Comments
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
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Dollar sign droplet above test tube
Ocular

Financing at Gelmedix supports GMX-101 for geographic atrophy

Feb. 18, 2026
No Comments
Gelmedix Inc. has completed a $13 million seed financing to support progression of the company’s lead program, GMX-101, a retinal pigment epithelial (RPE) cell therapy to treat late-stage geographic atrophy.
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Brain, syringe hovering over hands
Neurology/psychiatric

Stem cell-derived factor has potential in anti-NMDAR encephalitis

Feb. 16, 2026
No Comments
Researchers have explored the effects of human umbilical cord mesenchymal stem cells (hUC-MSCs) on cognitive recovery in anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis, a rare, neuronal antibody-mediated disorder characterized by neuropsychiatric symptoms and impaired cognitive function. hUC-MSCs have previously shown immunomodulatory and anti-inflammatory properties.
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Illustration of lymphocytes
Neurology/psychiatric

TRX-319 silences autoreactive B and T cells in multiple sclerosis

Feb. 11, 2026
No Comments
Researchers from Tr1x Inc. presented the development of TRX-319, a novel allogeneic regulatory T-cell therapy designed for the treatment of autoimmune disorders.
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T cells attacking cancer
Newco news

Vibrant aims to tame EGFR tumors with masked TCEs

Feb. 10, 2026
By Tamra Sami
No Comments
After raising $61 million in a series B round, Vibrant Therapeutics Inc. is gearing up to begin a U.S. phase I trial with its lead program, VIB-305, a masked T-cell engager (TCE) for treating EGFR-positive solid tumors.
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T cells attacking cancer
Newco news

Vibrant aims to tame EGFR tumors with masked TCEs

Feb. 5, 2026
By Tamra Sami
No Comments
After raising $61 million in a series B round, Vibrant Therapeutics Inc. is gearing up to begin a U.S. phase I trial with its lead program, VIB-305, a masked T-cell engager (TCE) for treating EGFR-positive solid tumors.
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