Novartis Pauses Eight CAR-T Trials After Three Patient Deaths; Bristol Myers Halts Enrollment

โดย Insider Monkey·USCH·Read original
Summary · why it matters

Novartis AG paused eight clinical trials of its experimental CAR-T cell therapy rap-cel in autoimmune and neurological conditions, including lupus, rheumatoid arthritis, and multiple sclerosis, after three patients died from immune effector cell-associated hemophagocytic syndrome, a rare and severe immune reaction, as first reported by the Wall Street Journal on September 1, 2026. The pause does not cover the company's two ongoing rap-cel trials in lymphoma and leukemia, which continue. Bristol-Myers Squibb Company separately paused enrollment in its own competing CAR-T program, zola-cel, as a precaution after observing what it described as transient and reversible inflammatory events, with no reported deaths. Bristol-Myers informed regulators and researchers in early June but waited about three months before informing the broader public, while Novartis confirmed its pause only after an analyst noticed the halted trials in a public database and disclosed the deaths one week later. Hedge fund count for Novartis grew to 38 in the second quarter from 31 in the first, with position value rising to $3.66 billion from $3.02 billion, while Bristol-Myers holders fell to 74 from 83 and position value declined to $4.79 billion from $5.97 billion.

Impact on assets 6

Biotech & Genomic Medicine▼ · 5 stocks
Novartis AG
NOVN
▼ NegativeRegulationrelevance

Novartis paused eight rap-cel CAR-T trials in autoimmune and neurological conditions after three patient deaths from a severe immune reaction.

Bristol-Myers Squibb Company
BMY
▼ NegativeRegulationrelevance

Bristol-Myers paused enrollment in its competing CAR-T program zola-cel and delayed informing the public for about three months, drawing regulatory scrutiny.

Longevity & Life Extension▲ · 1 stocks

Theme Impact 2

Related news

United States
▲

Iovance Biotherapeutics Fair Value Raised to US$12.80 on Amtagvi Demand

The fair value estimate for Iovance Biotherapeutics has been raised to US$12.80 per share from US$10.00, according to Simply Wall St. The revision reflects stronger expectations for the Amtagvi launch, margin trends and upcoming data, with the revenue growth assumption shifting from 43.38% to 45.57% and the net profit margin assumption moving from 9.50% to 12.09%. H.C. Wainwright lifted its price target to US$20 from US$9, citing FY26 total revenue guidance of US$410m to US$420m tied to U.S. demand for Amtagvi and Proleukin, while Wells Fargo moved to US$18 from US$14 and Goldman Sachs pointed to an inflection in the Amtagvi launch and easing logistical challenges. Barclays flagged durability in second line lung cancer for lifileucel ahead of IOV-LUN-202 data, while UBS, which raised its target to US$7 from US$4 and remains Neutral, noted that a strong Amtagvi quarter and gross margin of 56% came alongside a 74% rally in the stock. The valuation model's future P/E multiple changed from 75.55x to 72.80x and the discount rate moved from 7.47% to 7.50%.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics ▲Demand
Biotech & Genomic Medicine › Cell Therapy (CAR-T & beyond) ▲Demand
IOVA · Capital · Positive Multiple analysts raised price targets and fair value on stronger Amtagvi launch expectations, margin trends, and revenue guidance.
IOVA · Demand · Positive FY26 revenue guidance tied to U.S. demand for Amtagvi and Proleukin, with an inflection in the Amtagvi launch.
Read original ↗
Simply Wall St·1dRead more →
GlobalUnited StatesUnited KingdomFrance
▲

Cell and Gene Therapy Bio-Manufacturing Market to Reach $21.46 Billion by 2030

The global cell and gene therapy biomanufacturing market is projected to grow from $12.35 billion in 2025 to $13.83 billion in 2026, a compound annual growth rate of 12%, and to reach $21.46 billion by 2030 at a compound annual growth rate of 11.6% from 2026, according to the Cell and Gene Therapy Bio-Manufacturing Market Global Report 2026 added to ResearchAndMarkets.com. Growth is being driven by the increasing commercialization of cell and gene therapies, demand for scalable viral vector production, wider adoption of personalized medicine, and expansion among contract development and manufacturing organizations, alongside automation, digitalization, and investment in modern biomanufacturing facilities. The report cites the American Society of Gene and Cell Therapy's finding that the number of gene therapies in Phase III development increased by 10% during the fourth quarter of 2023 compared with the previous quarter, the first quarterly increase since the third quarter of 2022. In May 2026, Andelyn Biosciences launched its LVV Curator platform to streamline lentiviral vector manufacturing, using a modular, prevalidated framework based on Curator methodology previously applied across more than 100 adeno-associated virus programs. In January 2024, Oxford Biomedica plc acquired ABL Europe SAS for $17.35 million, expanding its manufacturing presence in Europe and its viral vector development and production services. North America was the largest cell and gene therapy biomanufacturing market in 2025, while Asia-Pacific is forecast to be the fastest-growing region; companies featured include Thermo Fisher Scientific Inc., Merck KGaA, Lonza Group AG, and Samsung Biologics Co. Ltd.
About megatrends
Biotech & Genomic Medicine › Tools, Diagnostics & CDMO ▲Technology
Biotech & Genomic Medicine › CDMO / Contract Manufacturing ▲Technology
Biotech & Genomic Medicine › Cell Therapy (CAR-T & beyond) ▲Technology
OXB.LSE · Capital · Positive Oxford Biomedica acquired ABL Europe SAS for $17.35 million, expanding its European viral vector manufacturing presence.
Read original ↗
ResearchAndMarkets.com·3dRead more →
United States
2

Ligand Pharmaceuticals Strikes US$47 Million AvenCell CAR-T Financing Deal

Ligand Pharmaceuticals has entered a US$47 million financing agreement with AvenCell Therapeutics, comprising up to US$6 million in Series C funding and as much as US$41 million tied to clinical milestones for AvenCell's CAR-T therapy programs. The deal deepens Ligand's royalty-focused model by adding potential royalty streams on AvenCell's current and future pipeline, further broadening its portfolio of over 200 partnered assets following the XOMA Royalty acquisition. The new milestone-linked exposure comes as Ligand faces partner execution questions, including a recent termination notice to Viking Therapeutics over the TR Beta program. Ligand's narrative projects $481.1 million in revenue and $273.9 million in earnings by 2029, with a fair value estimate of $342.82, a 9% upside to its current price. Before the AvenCell deal, the most optimistic analysts had already assumed revenue could reach about US$538 million and earnings about US$277 million by 2029.
About megatrends
Biotech & Genomic Medicine › Cell Therapy (CAR-T & beyond) Capital
LGND · Capital · Positive Ligand signs a US$47M financing deal with AvenCell, adding milestone-linked royalty exposure to its portfolio.
AvenCell Therapeutics · Capital · Positive AvenCell secures up to US$47M in Series C funding and milestone payments from Ligand for its CAR-T programs.
VKTX · Regulation · Negative Article notes Ligand recently issued a termination notice to Viking Therapeutics over the TR Beta program.
Read original ↗
Simply Wall St·5dRead more →