A Wall Street Analyst Spotted the Trial Freeze—Then Came News of Three Deaths

Pharmaceutical giants delayed public disclosure of critical safety halts in CAR-T clinical trials, leaving patients, medical professionals, and investors uninformed about severe adverse events and patient deaths for weeks or months.

Unannounced Pauses And Secret Fatalities

The Wall Street Journal on Friday noted that Bristol Myers Squibb & Co. (NYSE:BMY) halted enrollment in its autoimmune study for zola-cel in June after detecting cases of brain inflammation, known as ICANS.

Although the drugmaker notified federal regulators promptly, three months passed before the firm shared the pause publicly.

The WSJ also noted that Novartis AG (NYSE:NVS) suspended trials for its competing therapy, rap-cel, after three patients died from a rare immune system overreaction.

The company confirmed the deaths only after an analyst at William Blair noticed database changes, leading to reports by Endpoints News, the report highlighted.

Manufacturing Platforms And Complications

Both companies re-engineer patient immune cells to treat disabling autoimmune conditions such as lupus and rheumatoid arthritis. However, distinct manufacturing methods may influence toxicity risks.

Citing an Oppenheimer analyst, the report added that Novartis compresses cell growth into roughly one day, causing cells to multiply aggressively inside patients.

Conversely, Bristol Myers uses a five-day platform designed to let cells stabilize prior to infusion, characterizing its adverse events as non-fatal, transient, and reversible.

Regulatory Discretion Triggers Industry Alarm

While federal regulations require companies to submit rapid safety reports to regulators, no mandates require public disclosure unless trials materially impact bottom lines.

The discretion leaves hundreds of enrolled participants without timely risk updates.

The withholding of clinical information has alarmed advocacy groups and clinical trial researchers. Scleroderma trial participant Sue Chrysogelos criticized the lack of shared knowledge, while trial physician Dr. Anca Askanase confirmed receiving written notice from Bristol Myers regarding the study pause.

Price Action: Novartis shares were down 1.58% at $160.52 and Bristol-Myers Squibb shares were down 1.73% at $66.91 at the time of publication on Friday, according to Benzinga Pro data.

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