4Mes
@Multibagger @Dividendenopi @Tenbagger2024
Things could now be looking up again. Corcept reports today, May 27, 2026, that the NDA application for Relacorilant for the treatment of Cushing's syndrome will be resubmitted. According to Corcept, the FDA requested additional analyses of the existing NDA data after the CRL; Corcept now says these analyses have been completed and will be included in the resubmission. This sounds more like "FDA may accept an analysis/data pathway" and not necessarily "new large study required". This is the key bullish point.
However, the case has changed significantly since then: Relacorilant has since been approved for platinum-resistant epithelial ovarian cancer in combination with nab-paclitaxel (my god does that sound complicated to a non-physician); Reuters reported the FDA approval on 3/25/2026 under the brand name Lifyorli, citing trial data with median overall survival of 16 months vs. 11.9 months with chemotherapy alone. This removes some of the binary risk for Corcept because Relacorilant is no longer just a "failed Cushing's candidate" but is already commercially viable.
I'll stay invested, if necessary I'll add a little more on a dip.
https://ir.corcept.com/news-releases/news-release-details/corcept-resubmit-its-new-drug-application-relacorilant-treatment
Things could now be looking up again. Corcept reports today, May 27, 2026, that the NDA application for Relacorilant for the treatment of Cushing's syndrome will be resubmitted. According to Corcept, the FDA requested additional analyses of the existing NDA data after the CRL; Corcept now says these analyses have been completed and will be included in the resubmission. This sounds more like "FDA may accept an analysis/data pathway" and not necessarily "new large study required". This is the key bullish point.
However, the case has changed significantly since then: Relacorilant has since been approved for platinum-resistant epithelial ovarian cancer in combination with nab-paclitaxel (my god does that sound complicated to a non-physician); Reuters reported the FDA approval on 3/25/2026 under the brand name Lifyorli, citing trial data with median overall survival of 16 months vs. 11.9 months with chemotherapy alone. This removes some of the binary risk for Corcept because Relacorilant is no longer just a "failed Cushing's candidate" but is already commercially viable.
I'll stay invested, if necessary I'll add a little more on a dip.
https://ir.corcept.com/news-releases/news-release-details/corcept-resubmit-its-new-drug-application-relacorilant-treatment
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@toscho thank you dear, as far as I could see the profit estimates for next year are even in triple digits
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•4Mes
Yes, I also think that we need time here. The FDA's decision will probably take 6 months. Then next year maybe...
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@toscho I am and remain convinced. It will reach triple digits next year at the latest.
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