Sanaregen Vision Therapeutics Inc. has received FDA clearance to conduct a phase I/II trial of SVT-001, an investigational cell therapy for individuals with familial drusen.

CAR T cells have been groundbreaking for the treatment of B-cell cancers. But 8 years after Kymriah (tisagenlecleucel, Novartis AG) became the first CAR T-cell therapy to be approved, there are no CAR Ts approved for solid tumors.

In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway.

Innovacell Inc. launched a ¥14.16 billion (US$91.2 million) stock sale on the Tokyo Stock Exchange Feb. 24, ending a near two-year lull of biotech listings in Japan while signaling a dynamic year ahead for cell-based therapeutics.

Astellas Pharma Inc. and Vir Biotechnology Inc. have signed a global co-development pact to advance VIR-5500, Vir’s PRO-XTEN dual-masked CD3 T-cell engager targeting prostate-specific membrane antigen for treating prostate cancer. Under the deal terms, San Francisco-based Vir will receive $335 million in up-front and near-term payments, including $240 million in cash, $75 million in equity investment and a $20 million near-term milestone. Vir is also eligible to receive up to $1.37 billion in development, regulatory and sales-based milestones plus royalties on ex-U.S. sales.

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.

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.

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.

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.

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.