Loading...
•
Jun 30, 2023
uniQure Q2 2023 Earnings Report
uniQure reported encouraging interim analysis data from Phase I/II clinical trial of AMT-130 in Huntington’s disease and is preparing to initiate two Phase I/II clinical trials in refractory temporal lobe epilepsy and SOD1-ALS later this year.
Key Takeaways
uniQure announced its financial results for the second quarter of 2023, highlighting encouraging data from its AMT-130 Huntington's disease trial and preparations for new clinical trials. The company's cash position is strong with $628.6 million, excluding a $100 million milestone received in July.
Announced encouraging interim analysis data from Phase I/II clinical trial of AMT-130 in Huntington’s disease showing preservation of function compared to baseline and clinical benefits relative to natural history.
Preparations underway to initiate two Phase I/II clinical trials in refractory temporal lobe epilepsy and SOD1-ALS later this year; IND for Fabry disease expected to be submitted in the second half of 2023.
Strong cash position of $628.6 million as of June 30, 2023, which excludes a $100 million milestone related to first commercial sale of HEMGENIX® in the U.S. received in July 2023.
Announced sale of royalty interest in HEMGENIX® for up to $400 million.
Forward Guidance
The company provided forward-looking statements regarding its ability to fund operations into 2026, continued progress on the commercialization of HEMGENIX®, clinical benefits for patients treated with AMT-130, the timing of patient enrollment in the AMT-130 clinical trial, submission of an investigational new drug application for Fabry disease in 2023, initiation of a Phase I/II clinical study of AMT-162 for the treatment of ALS in the second half of 2023, submission of an investigational new drug application or initiation of a Phase I/II clinical study of AMT-260 for rTLE in the second half of 2023, and interactions with regulatory agencies in the first quarter of 2024.
Positive Outlook
- Continued progress on the commercialization of HEMGENIX®
- Clinical benefits for patients treated with AMT-130
- Patient enrollment in the AMT-130 clinical trial
- Submission of an investigational new drug application for Fabry disease in 2023
- Initiation of a Phase I/II clinical study of AMT-162 for the treatment of ALS in the second half of 2023
Challenges Ahead
- Risks associated with the regulatory approval and commercial launch of HEMGENIX®
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...