Bristol Myers Squibb has told Orum Therapeutics it is ending development of BMS-986497 (ORM-6151), a degrader-antibody conjugate that pairs a CD33-targeting antibody with a GSPT1 degrader, after reviewing Phase 1 data in acute myeloid leukemia and high-risk myelodysplastic syndrome, Korea Biomedical Review reported on September 18, 2026. BMS bought the program from Orum in October 2023 for $100 million upfront in a deal worth up to $180 million; Orum keeps the upfront payment but is no longer eligible for up to $80 million in remaining milestones. Orum said it was notified unexpectedly and is assessing the situation. It will concentrate on ORM-1153, a CD123-targeting degrader-antibody conjugate for the same indications, for which the FDA has cleared an investigational new drug application.
Novartis (NYSE: NVS) initiated clinical holds on all rap-cel (YTB323, an autologous CD19-directed CAR-T cell therapy) autoimmune trials on August 24, 2026 following three fatal cases of immune effector cell-associated hemophagocytic syndrome, a rare life-threatening inflammatory reaction. Affected trials cover lupus (systemic lupus erythematosus), myasthenia gravis, multiple sclerosis, systemic sclerosis, idiopathic inflammatory myopathies, and additional autoimmune indications. Bristol Myers Squibb (NYSE: BMY) voluntarily paused enrollment in its own zola-cel (zolacabtagene autoleucel, another autologous CD19 CAR-T) autoimmune trials after detecting transient and reversible inflammatory events during routine safety surveillance; BMS had halted the enrollment in June 2026 after cases of brain inflammation but did not publicly disclose the pause until three months later. Novartis and BMS were the leading commercial-scale CAR-T-in-autoimmune-disease players; the paired pauses are a substantial setback for the category, which had been the hottest cell-therapy expansion area of 2026 after Kyverna, Cabaletta Bio, and multiple academic centers reported dramatic clinical responses in refractory lupus and neurological autoimmune disease.
The Factor XIa inhibitor milvexian (an oral small-molecule antithrombotic co-developed by Bristol Myers Squibb (NYSE: BMY) and Janssen) failed to reduce major adverse cardiovascular events versus placebo when added to standard antiplatelet therapy after recent acute coronary syndrome (ACS) in the Phase 3 LIBREXIA ACS trial presented in a Hot Line Session at ESC Congress 2026 Saturday August 29. The primary endpoint (cardiovascular death, myocardial infarction, or ischemic stroke) occurred in 5.4% of the milvexian arm versus 5.1% on placebo. Researchers observed no differences in intracranial or fatal bleeding between arms, addressing safety concerns that have historically constrained anticoagulant use in the post-ACS setting. The LIBREXIA program continues to assess milvexian in stroke and atrial fibrillation. The Factor XIa class as a whole (also including Bayer-Janssen's asundexian and Anthos Therapeutics' abelacimab) has struggled to demonstrate clean cardiovascular benefit at low bleeding cost.
Bristol Myers Squibb (NYSE: BMY) on Wednesday August 26, 2026 ended its cell therapy manufacturing alliance with Cellares (South San Francisco) after finding that Cellares' Cell Shuttle automated production system failed to meet the requirements for making the CAR-T immunotherapy Breyanzi (lisocabtagene maraleucel). BMS and Cellares had signed a $380 million global capacity reservation and supply agreement in 2024 that positioned BMS to use Cell Shuttle for end-to-end automated CAR-T production at clinical and commercial scales. Cellares announced 100 layoffs (roughly 20% of the workforce) in response to the loss of the contract, coming just two months after closing a $327 million Series D. Cellares CEO Fabian Gerlinghaus said the company will 'resize' operations. The story is a data point on the fragility of contract cell-therapy manufacturing platforms and, by extension, a caution flag on the parallel automated-peptide-synthesis vendor category as GLP-1 and next-gen peptide production leans further on continuous-flow and automated platforms.