Polyrizon Ltd. Ordinary Shares

uniQure led a group of biotech gainers on Wednesday after the FDA softened its stance on the company’s investigational gene therapy AMT-130 for Huntington’s disease. The agency now considers the 3-year analysis from the Phase I/II study acceptable as the primary basis for a Biologics License Application for accelerated approval, reversing its earlier recommendation for a prospective, randomized, double-blind, sham-surgery-controlled study. uniQure intends to submit the BLA in the third quarter of 2026, and its shares closed at $48.16, up 78.44%. Other notable movers included Elicio Therapeutics, which rose 70.65% after reporting that three advanced pancreatic cancer patients in its Phase 2 AMPLIFY-7P study achieved complete responses following treatment with its vaccine ELI-002 7P and subsequent checkpoint inhibitor therapy. Lunai Bioworks gained 40.06% after its CEO outlined developments including a first revenue-generating U.S. government defense contract and the formation of the Pathfinder Consortium. ClearPoint Neuro climbed 26.01% on spillover optimism related to uniQure’s AMT-130, which is administered using ClearPoint’s navigation system. Polyrizon added 15.55% after the publication of a U.S. patent application for its nasal drug delivery technology, and Faeth Therapeutics rose 14.59% as it anticipates topline data from a Phase 2 trial of its lead candidate PIKTOR in advanced endometrial cancer in the second half of 2026.