New therapies including CAR-T, bispecific antibodies and dual-antibody immunotherapy are reshaping multiple myeloma care. Advances in genomic testing may also improve risk assessment and treatment decisions.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Autolus Therapeutics reported $74.3 million in 2025 revenue during its first commercial year, while facing a -265% gross margin. The company aims to achieve positive margins by 2026 through scaling production and expanding into autoimmune diseases with promising early lupus trial results. The broader CAR-T therapy market is projected to reach $9.85 billion in the US by 2033.
A phase 1 trial shows denileukin diftitox administered before CAR-T therapy has a favorable safety profile and encouraging efficacy in high-risk DLBCL patients, with an 86% overall response rate and 77% one-year progression-free survival. The treatment demonstrated consistent regulatory T-cell depletion, supporting its immunomodulatory mechanism. Larger controlled studies are needed to confirm these preliminary findings.
The cell therapy manufacturing market is projected to reach $14.01 billion by 2035, with CAR-T therapies dominating at 65% market share. Recent FDA approvals for new CAR-T indications and Japanese regulatory acceleration highlight growing clinical adoption, while research advances include new anti-aging protein platforms and CRISPR-based treatments.
A study of 366 patients found ide-cel CAR-T cell therapy achieved 81.6% overall response rate in patients 70 or older with relapsed/refractory multiple myeloma, with median progression-free survival of 18.9 months versus 5.7 months with standard regimens.
C4 Therapeutics has initiated its Phase 2 MOMENTUM trial of cemsidomide in relapsed/refractory multiple myeloma, targeting enrollment completion in Q1 2027 and a registrational dataset by 2028. The company plans a combination study with elranatamab in Q2 2026.
Next-generation in vivo CAR-T therapy enables cancer treatment with a single injection, while new Texas legislation and community-based delivery models expand patient access to this advanced cellular therapy.
Gilead Sciences has agreed to buy immunotherapy cancer biotech Arcellx in a deal worth $7.8 billion, deepening its bet on cancer immunotherapy and its existing partnership with the company.
Gilead Sciences will acquire Arcellx for $7.8 billion to expand their CAR-T cell therapy collaboration. The deal includes $115 per share at closing plus contingent payments based on sales milestones.
