I want to also ask you about something that the secretary of uh health and human services asked you to review. I think it was last month. Uh looking at the latest data on methapristone, more commonly known as the abortion pill.Is that review still ongoing. Has it begun. What are you looking at here.And why is it being reviewed in the first place given the fact that there aren't safety concerns about this drug. >> Yeah. So uh as a part of a regulation called the REM, the risk evaluation and and mitigation st ...

The Food and Drug Administration is allowing Juul, the brand widely blamed for sparking the teen vaping trend, to keep its ecigarettes on the market. That decision, announced late last week, concludes a multi-year review that left the products in limbo. Juel is celebrating the move, but others are criticizing it, including Democratic Senator Dick Durban of Illinois, who claims the company ignited a youth vaping epidemic and is calling on FDA Commissioner Dr.. Marty McCary to reverse the decision. Dr.. McCar ...

Core Insights - Corcept Therapeutics (CORT) has submitted a new drug application (NDA) to the FDA for its lead candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [1][7] - The NDA submission is based on positive data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [3][2] - The company aims to diversify its product offerings beyond its sole marketed drug, Korlym, to reduce reliance on it for growth [9][7] NDA Submissions and Studies - In December 2024, CORT submitted an NDA for relacorilant to treat hypercortisolism (Cushing's syndrome), which was accepted by the FDA in March 2025 with a target action date of December 30, 2025 [5][2] - The NDA for platinum-resistant ovarian cancer is supported by data from the ROSELLA study and other phase II studies [2][3] - CORT is also conducting additional studies, including the BELLA study, which evaluates relacorilant in combination with nab-paclitaxel and Roche's Avastin for the same indication [10] Financial Performance - Year to date, CORT shares have increased by 44.4%, significantly outperforming the industry average rise of 4.1% [4] - Korlym generated sales of $157.2 million in Q1 2025, reflecting a year-over-year increase of 7.1% due to strong demand [8] Pipeline and Future Prospects - CORT is exploring relacorilant in combination with Xtandi for early-stage prostate cancer and evaluating its selective cortisol modulator dazucorilant for amyotrophic lateral sclerosis (ALS) [11] - Another candidate, miricorilant, is being studied for metabolic dysfunction-associated steatohepatitis [12] - A potential approval for relacorilant could expand CORT's patient base and reduce dependence on Korlym for long-term growth [9]