uniQure N.V. Stock News

~ Alignment with FDA continues to support Accelerated Approval pathway ~ ~ BLA submission planned for first quarter of 2026 ~ ~ Conference call today at 8:30 a.m. ET ~ LEXINGTON, Mass.

uniQure recently divested from its Lexington facility to Genezen and freed $25 million while significantly reducing its operating costs. At the same time, AMT-130 has received the FDA's Breakthrough Therapy, RMAT, Fast-Track, and Orphan Drug status with Accelerated Approval via cUHDRS. Similarly, QURE is building MRI-guided infusion centers, payer-access teams, and a US Center of Excellence net...

NORWOOD, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company focused on oncology and obesity, today announced the appointment of Rachelle Jacques as Chair of its Board of Directors, effective May 15.

uniQure N.V. (NASDAQ:QURE ) Q1 2025 Earnings Conference Call May 9, 2025 8:30 AM ET Company Participants Chiara Russo - Senior Director, Investor Relations Matt Kapusta - Chief Executive Officer Walid Abi-Saab - Chief Medical Officer Christian Klemt - Chief Financial Officer Conference Call Participants Luca Issi - RBC Debjit Chattopadhyay - Guggenheim Paul Matteis - Stifel Patrick Trucchio - H.C.

~ AMT-130 granted Breakthrough Therapy designation by FDA ~ ~ Initial safety data from third cohort of Phase I/II study show AMT-130 continues to be generally well-tolerated, with no treatment-related serious adverse events ~ ~ Held Type B FDA meetings in the first and second quarters of 2025 to advance BLA preparations for AMT-130; regulatory update expected in the second quarter of 2025 ~ ~ A...

uniQure's lead program for Huntington's Disease is planning to file an application via the accelerated approval pathway. On Monday, May 5th, PTC Therapeutics announced positive results from their phase 2 Huntington's Disease trial. I compare the data from these two treatments and share my thoughts here.

~ uniQure to host inaugural earnings call on Friday, May 9, 2025 at 8:30 a.m. ET ~ ~ uniQure to host inaugural earnings call on Friday, May 9, 2025 at 8:30 a.m. ET ~

uniQure's AMT-130 gene therapy for Huntington's Disease shows promising trial data, leading to significant stock price increases and potential for FDA accelerated approval. QURE's stock has seen volatility but has near-term catalysts like BLA submission and 36-month trial data, suggesting potential for immediate further gains. Despite competition from PTC518, AMT-130's effectiveness and one-tim...