FDA goes on offense amid surge of criticism for recent drug decisions [CNN]
uniQure N.V. - Ordinary Shares (QURE)
Last uniqure n.v. - ordinary shares earnings: 4/29 07:00 am
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uniqure.com/investors-newsroom/overview.php
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Source: CNN
The call focused on the FDA's decision to ask for an additional clinical trial from the biotechnology company UniQure before greenlighting it to apply for approval of its gene therapy for Huntington's disease, a fatal neurodegenerative disorder. Patients and the company had hoped the therapy could move into an FDA review based on existing evidence, a hope that was dashed Monday. But the regulator, who spoke on the condition of anonymity, also attacked outside scientists who serve on advisory committees for the agency, saying they “do not do their homework” and may be motivated by financial conflicts of interest. The official additionally singled out Dr. Janet Woodcock, a retired FDA veteran who called the UniQure decision “truly evil” in an interview with the New York Times this week. “Dr. Woodcock is an esteemed regulator,” the official said, “and as such, there are many commenters who I don't expect better from, but Dr. Woodcock, I do expect better from.” Woodcock declined to
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News
- FDA goes on offense amid surge of criticism for recent drug decisions [CNN]CNN
- INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in uniQure N.V. of Class Action Lawsuit and Upcoming Deadlines - QUREPR Newswire
- Holzer & Holzer, LLC Reminds QURE Investors of the April 13, 2026 Lead Plaintiff Deadline in the uniQure N.V. Securities Class ActionGlobeNewswire
- FDA official calls UniQure's Huntington's disease treatment a failure [Yahoo! Finance]Yahoo! Finance
- FDA official calls UniQure's gene therapy a ‘failed' treatment for Huntington's disease [CNBC]CNBC
QURE
Earnings
- 11/10/25 - Miss
QURE
Sec Filings
- 3/4/26 - Form 144
- 3/4/26 - Form 144
- 3/4/26 - Form 144
- QURE's page on the SEC website