प्राथमिक स्रोत रिकॉर्ड
निर्णायकटॉपलाइन परिणाम
Corcept: प्लैटिनम-प्रतिरोधी ओवेरियन कैंसर में relacorilant के फेज 3 ROSELLA अध्ययन ने OS एंडपॉइंट पूरा किया
ROSELLA Phase 3 trial met its overall-survival primary endpoint, showing a 35 % reduction in risk of death (HR 0.65, p=0.0004) and a 4.1-month median-OS gain (16.0 vs 11.9 months) with relacorilant plus nab-paclitaxel versus nab-paclitaxel alone. The NDA for relacorilant in platinum-resistant ovarian cancer remains under FDA review with a PDUFA target action date of July 11, 2026; an MAA is also under EMA review.
मुख्य तथ्य
- फाइल किया गया
- 22 जन॰ 2026, 01:10 pm
- घटना
- टॉपलाइन परिणाम
- दिशा
- सकारात्मक
- कंपनी
CORTCorcept- संपत्ति
- relacorilant
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- माध्यिका ओएस
- 16.0 बनाम 11.9 महीने
- ओएस पी मान
- 0.0004
- पीएफएस पी मान
- 0.008
- ओएस हैज़र्ड अनुपात
- 0.65
- पीएफएस हैज़र्ड अनुपात
- 0.70
स्रोत का अंश
EX-99.1 2 d96058dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 CONTACT: Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com www.corcept.com Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer • Data demonstrate a 35 percent reduction in the risk of death • Both dual primary endpoints (progression-free and overall survival) were met, without the need for biomarker selection and without increased safety burden • Relacorilant’s New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) as a treatment for patients with platinum-resistant ovarian cancer with a Prescription Drug User Fee Act (PDUFA) target action date of July 11, 2026 •
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