Corcept Therapeutics

Dazucorilant, a cortisol modulator, failed to slow ALS progression in a Phase 2 trial, showing no significant difference over placebo. Gastrointestinal side effects were more common with dazucorilant. Five deaths occurred in the placebo group compared to none in the high-dose group. Participants are now in an open-label extension study. Complete results will be presented at a scientific conference next year.

Corcept Therapeutics reported positive long-term outcomes from its Phase III study of relacorilant, a treatment for Cushing’s syndrome, showing sustained cardiometabolic improvements and high tolerance over six years. After 24 months, subjects showed significant reductions in mean systolic and diastolic blood pressure, with notable improvements in those switched from placebo. Relacorilant targets the glucocorticoid receptor and is being investigated for various cancers.

Corcept's CATALYST trial showed Korlym significantly reduced hemoglobin A1c by 1.47% vs 0.15% in placebo group (p<0.0001). 23.8% of 1,057 screened diabetes patients had hypercortisolism; 136 were treated. Safety profile consistent with Korlym's label.

The 'Cushing Syndrome - Pipeline Insight, 2024' report by ResearchAndMarkets.com details 4+ companies and 4+ pipeline drugs for Cushing Syndrome, including profiles of clinical and nonclinical stage products, therapeutic assessments, and pipeline development activities. Key players include Corcept Therapeutics, Sparrow Pharmaceuticals, and Crinetics Pharmaceuticals, with notable drugs like Relacorilant, SPI 62, and CRN-04894.

In today’s OncLive On Air, host Ashling Wahner interviews Premal Thaker, MD, MS, about relacorilant (CORT125134) in ovarian cancer, discussing its combination with nab-paclitaxel (Abraxane) for platinum-resistant cases, phase 2 data, and the upcoming phase 3 ROSELLA trial.

Trump's reelection may boost biotech innovation and M&A activity, potentially repealing the Inflation Reduction Act. Key roles in federal health agencies will influence drug pricing reforms. The Zacks Medical-Drugs industry, despite headwinds, shows promising trends with innovation in diabetes/obesity, inflammation, and neuroscience. Small drugmakers rely on collaboration partners and R&D funding, with notable stocks including Corcept Therapeutics, Madrigal Pharmaceuticals, Catalyst Pharmaceuticals, Theravance Biopharma, and Larimar Therapeutics.

Corcept Therapeutics' Phase III GRADIENT trial for relacorilant in Cushing’s syndrome missed its primary endpoint of systolic blood pressure improvement. However, the trial met secondary endpoints for hyperglycemia, weight, and body composition, with relacorilant showing significant improvements over placebo. The drug was well-tolerated, with no reported adverse effects like hypokalemia or adrenal insufficiency. The trial results will support the NDA submission this quarter, alongside data from the GRACE trial.

Corcept Therapeutics reports Q3 2024 revenue of $182.5M, up 48% YoY, and increases 2024 revenue guidance to $675-$700M. Net income per share is $0.41 (diluted), with cash and investments at $547.6M. The company plans to submit an NDA for relacorilant this quarter, supported by Phase 3 GRADIENT trial results.