What happened
Shares of uniQure N.V. (QURE 6.08%) are crashing today, down by 32.6% as of 11:19 a.m. ET. The steep decline came after the gene therapy specialist provided its second-quarter update Monday morning.
Investors weren't all that interested in uniQure's financial results. The company's only revenue is from collaborations. uniQure reported a net loss in Q2 of $39.1 million, or $0.84 per share, on revenue of just $0.5 million.
So why did the biotech stock plunge so much? uniQure announced the postponement of adding higher-dose procedures in a phase 1/2 study of AMT-130 in treating early-stage Huntington's disease.
NASDAQ: QURE
Key Data Points
So what
uniQure only has two programs in clinical testing, one of which is AMT-130. Any bad news for the experimental gene therapy, therefore, will almost certainly rattle investors.
In July, the company reported that three of 14 patients treated with a higher dose of AMT-130 experienced unexpected severe adverse reactions. As a result, uniQure decided to delay any additional higher-dose procedures in the study until it can implement additional monitoring and treatment plans, as well as complete a safety review.
Importantly, there haven't been any reports of severe adverse events related to AMT-130 in patients receiving lower doses of the experimental therapy. uniQure doesn't expect any impact of its delay related to higher-dose procedures on the timing of announcing results from the lower-dose procedures.
Now what
uniQure expects to complete its safety review early in Q4 of this year. The company also continues to anticipate reporting data from one- to two-year follow-ups on both low- and high-dose cohorts of its AMT-130 clinical study in Q2 of 2023.
