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biotech — 2 leads

DayFoundLeadSectorScoreCatalystSrc
ThuSep 24Celldex's hives drug won two Phase 3 trials decisively, and the stock fell 18% on two anaphylaxis cases

On September 22, 2026 Celldex reported that barzolvolimab met every primary and key secondary endpoint in two Phase 3 trials of 1,939 patients with chronic spontaneous urticaria, with 45–54% of treated patients completely free of hives and itch at 24 weeks against 15–18% on placebo, but two life-threatening anaphylaxis cases in one dose group sent the shares down 18% in two sessions — the opportunity turns on whether the safety signal is a label problem or a commercial one, which the full safety tables and the 52-week data will settle.

biotech66Full 52-week EMBARQ data and a BLA submission planned for 2027; detailed safety tables not yet published as of September 24, 20265
MonAug 31An mRNA cancer vaccine passed Phase 3 for the first time

A cancer vaccine custom-built for each individual patient worked in a large trial for the first time ever.

Moderna already jumped on the news — but every single dose requires bespoke lab work, and the companies that would have to supply that are still priced for the post-COVID collapse.

biotech72Data release, then FDA filing3

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