UK regulator halts Tavneos sales on September 02, 2026 Accelerated AMT-130 Approved avacopan gene therapy Huntington 's disease MHRA Regulators (device) Tavneos UK uniQure United States Food and Drug Administration +
Rare Disease Drugmakers Watch FDA for Renewed Focus on Therapies on August 12, 2026 Accelerated Approved Capricor Therapeutics deramiocel gene therapy Individualized Mechanism Framework Muscular Dystrophy, Duchenne Rare Diseases Regenxbio uniQure United States Food and Drug Administration +
uniQure Announces Pricing of Upsized $225 Million Public Offering: Details and Highlights on June 24, 2026 Capital Erythrocytes Guggenheim Securities Leerink Partners Market Pricing public entity Stifel underwritten uniQure upsized +
In another reversal, FDA gives uniQure accelerated approval path for Huntington's gene therapy on June 18, 2026 Accelerated AMT-130 Approved Biologics License Application Breakthrough Therapy cUHDRS gene therapy Huntington 's disease NEFL gene Phase I/II study RMAT uniQure United States Food and Drug Administration +
UniQure stock surges after FDA U-turn clears path to gene therapy filing on June 17, 2026 Accelerated AMT-130 Approved Blackfoot language Clinical Research gene therapy Huntington 's disease Phase QURE surge U-turn uniQure United States Food and Drug Administration +
FDA's Shock Rejection of Ebvallo Cell Therapy: Reconsideration Efforts and uniQure Concerns on May 07, 2026 Atara Biotherapeutics Cell Therapy CRL Ebvallo IL31RA gene Pierre Fabre Post-transplant lymphoproliferative disorder Tabelecleucel uniQure United States Food and Drug Administration +
FDA Rejects UniQure's AMT-130 Gene Therapy Data for Huntington's, Demands New Sham-Controlled Trial on March 06, 2026 AMT-130 gene therapy Huntington 's disease Phase 1/2 data sham-controlled trial uniQure United States Food and Drug Administration +
UniQure's Huntington's Gene Therapy AMT-130 Faces FDA Roadblock, Requiring New Trial on March 02, 2026 AMT-130 gene therapy Huntington 's disease Phase 3 sham surgery uniQure United States Food and Drug Administration +
Biopharma Bites: uniQure Pauses AMT-191 Dosing, GSK's Nucala Gets EU Nod, Gilead CAR-T Label Update on February 10, 2026 AMT-191 Approved CAR-T dosing EU Fabry Disease gene therapy Gilead Labels (device) Nucala Pauses SmithKline Beecham uniQure update +
UniQure restates FDA’s negative feedback on Huntington’s trial on December 05, 2025 AMT-130 antibody collaboration AstraZeneca external control group Feedback - system communication gene therapy Nerve Degeneration Neurimmune uniQure United States Food and Drug Administration +
uniQure Faces Delay as FDA Walks Back Accelerated Approval for Huntington’s Gene Therapy on November 03, 2025 Accelerated AMT-130 Approved Clinical Trials gene therapy Huntington 's disease regulatory setback uniQure United States Food and Drug Administration +
uniQure's Gene Therapy AMT-130 Significantly Slows Huntington's Progression in Pivotal Trial on September 25, 2025 AMT-130 Approved Clinical Trials Disease Progression gene therapy huntingtin-lowering Huntington 's disease Nerve Degeneration uniQure United States Food and Drug Administration +