Biotech Market Disconnect: Celldex and Amgen Challenge Industry Assumptions
The biotech market has been experiencing a disconnect between its performance and the reality on the ground. Despite the modest decline in the XBI index, IPOs are pricing at record highs, but long-short funds are suffering due to their exposure to clinical catalysts.
Celldex's barzolvolimab results in chronic urticaria have raised questions about safety, with some arguing that the data should lead to a clean label. However, Yaron Werber estimates that 20-35% of patients have severe skin and angioedema involvement, making mast cell depletion an attractive treatment option.
The placebo arm in Celldex's Phase 3 study had 50% more anaphylaxis events than the drug arm, which had two cases out of 1,500 patients. Werber expects the skin clearance and angioedema benefit to land in the label, without a black box warning.
In another development, Amgen's dazodalibep has shown positive Phase 3 results in systemic Sjögren's disease, making it the only company with momentum in both symptomatic and systemic disease. Werber sizes the market at $25 billion in the U.S., with the symptomatic form accounting for two-thirds of the addressable population.