Lunai Bioworks Inc.

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.

CervoMed shares soared more than 80% on Tuesday with key clinical trial catalysts ahead, leading a group of biotech gainers. The company's lead drug candidate Neflamapimod is in development for dementia with Lewy bodies, with a Phase 3 trial planned for the second half of 2026, and has been selected for the EXPERTS-ALS platform in the UK, with first patient dosing anticipated in the fourth quarter of 2026. Simulations Plus agreed to be acquired by affiliates of Altaris for $375 million, or $18.50 per share, a 26% premium to its 60-day volume-weighted average price. NeOnc Technologies received its first international regulatory clearance from the Department of Health - Abu Dhabi to begin a Phase 2 trial of NEO212 for aggressive brain tumors. Lunai Bioworks regained compliance with Nasdaq's minimum bid price requirement, securing its listing. Other notable movers included Conexeu Sciences, which expanded its board and appointed a chief commercial officer, and Certara, which integrated its D360 platform with Secondary Intelligence software to improve off-target safety risk evaluation.