News Related to Stifel

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FDA Rejects uniQure's AMT-130 Data as Insufficient for Approval, Demands Sham-Controlled Trial

Mar 03, 2026

The FDA informed uniQure that Phase 1/2 study data for AMT-130 in Huntington's disease is insufficient to support a biologics license application, recommending a prospective, randomized, double-blind, sham surgery-controlled study instead.

Crinetics Reports Strong Early Sales for PALSONIFY, Positive Phase 2 Data for CAH Treatment

Feb 26, 2026

Crinetics Pharmaceuticals reported over $5 million in preliminary net product revenue for PALSONIFY in Q4 2025, while Phase 2 data for its congenital adrenal hyperplasia treatment showed promising results that analysts say have derisked the Phase 3 study design.