Aurinia Pharmaceuticals Aktie
WKN DE: A1W7D4 / ISIN: CA05156V1022
|
30.09.2025 03:10:41
|
Aurinia Pharma Reaffirms LUPKYNIS Safety And Efficacy Following Retracted FDA Official's Post
(RTTNews) - Responding to a now retracted LinkedIn post referencing voclosporin by an FDA official, Aurinia Pharmaceuticals Inc. (AUPH) stated that it stands firmly behind the favorable benefit/risk profile of LUPKYNIS (voclosporin). The drug received full FDA approval in January 2021, supported by data from AURORA 1—a large, randomized 52-week clinical trial. In April 2024, the FDA further approved a supplementary new drug application for long-term use of LUPKYNIS, based on AURORA 2 results, which confirmed sustained efficacy over three years and a safety profile consistent with AURORA 1.
Earlier today, George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research, reportedly said in a LinkedIn post that the company's voclosporin, which was approved by the FDA in 2021, has "significant toxicity" and has not been shown to have a positive impact on patients. CDER will be evaluating surrogate endpoints used for FDA approval.
AUPH closed Monday's regular trading at $11.06 down $2.08 or 15.83%. But in the After hours trading the stock gained $0.81 or 7.32%.
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Aurinia Pharmaceuticals Incmehr Nachrichten
|
30.07.25 |
Ausblick: Aurinia Pharmaceuticals öffnet die Bücher zum abgelaufenen Quartal (finanzen.net) | |
|
11.05.25 |
Ausblick: Aurinia Pharmaceuticals informiert über die jüngsten Quartalsergebnisse (finanzen.net) |
Analysen zu Aurinia Pharmaceuticals Incmehr Analysen
Aktien in diesem Artikel
| Aurinia Pharmaceuticals Inc | 10,71 | 2,24% |
|