Core Insights - Corcept Therapeutics' shares surged over 32% following FDA approval of its lead drug, relacorilant (brand name Lifyorli), for treating platinum-resistant epithelial ovarian cancer [1][2]. Drug Approval and Mechanism - The FDA approved Lifyorli for use in combination with nab-paclitaxel, specifically for adults with a form of ovarian cancer that recurs or progresses within approximately six months of platinum-based chemotherapy [2]. - Lifyorli functions by blocking cortisol-related stress signals, enhancing the responsiveness of cancer cells to chemotherapy [2]. Clinical Trial Results - The approval was based on a late-stage trial involving 381 patients, which demonstrated that those treated with the drug combination had a median survival of 16 months, compared to 11.9 months for those receiving chemotherapy alone [3]. Safety and Sales Projections - The treatment carries warnings for low white blood cell counts, serious infections, adrenal insufficiency, and potential harm to unborn babies, and is contraindicated for patients dependent on steroid medications [4]. - UBS analyst Ashwani Verma views the approval positively but notes the contraindication could pose challenges, estimating peak sales of around $550 million [4]. Previous Setbacks - In December, the FDA had previously declined to approve relacorilant for hypertension related to Cushing's syndrome, citing insufficient efficacy compared to a placebo and concerns over potential liver injury, which led to a 50% drop in the company's shares [5].

Core Insights - Anixa Biosciences, Inc. has provided an update on its Phase 1 ovarian cancer CAR-T clinical trial, highlighting positive patient outcomes following a protocol amendment that allows for significant dose escalation [1] Trial Overview - The trial involves liraltagene autoleucel (lira-cel), which targets the follicle-stimulating hormone receptor (FSHR) selectively expressed on ovarian cells and certain cancer cells, while sparing healthy tissue [2] - The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer who have not responded to standard chemotherapy and have progressed after two or more prior therapies [2] Patient Outcomes - Twelve patients have been treated at four dosage levels, with seven patients surviving beyond the expected median survival of approximately three to four months [3] - Notably, one patient survived 28 months post-treatment, while three others survived over one year (17, 15, and 14 months respectively) [4] Safety Profile - No dose-limiting toxicities (DLTs) have been observed, leading to the approval of a protocol amendment for significant dose escalation [5] - The favorable safety profile is believed to be partly due to the direct intra-peritoneal delivery of CAR-T cells, which may reduce systemic toxicity and enhance localized tumor targeting [6] Protocol Amendment - The amended protocol allows dosing to increase from 1×10⁵ to 1×10⁹ CAR-positive cells per kilogram of body weight, representing a two-order-of-magnitude increase [7] - The next patient cohort will receive 1×10⁷ cells/kg following a lymphodepletion regimen with cyclophosphamide and fludarabine [7] Lymphodepletion - Lymphodepletion is intended to reduce competing immune cells, creating a more favorable environment for CAR-T expansion and activity, although its role in solid tumors remains investigational [8] Market Reaction - Anixa Biosciences shares increased by 1.69% to $3.01 during premarket trading [8]