Corcept Therapeutics

Corcept Therapeutics reports positive long-term outcomes from Phase III study of relacorilant for Cushing's syndrome, showing sustained cardiometabolic improvements and high tolerance over six years. Subjects showed significant reductions in blood pressure and maintained other cardiometabolic responses. The data supports an upcoming NDA submission, positioning relacorilant as a potential new standard of care.

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.

Corcept Therapeutics' Phase 2 DAZALS study on dazucorilant for ALS did not meet its primary endpoint of slowing motor skill decline but observed lower mortality in the higher dose group. This finding suggests a potential neuroprotective effect, shifting ALS research focus towards cortisol modulation for extending survival.

Corcept Therapeutics' dazucorilant failed to slow ALS progression in a phase 2 trial, missing primary endpoints and causing more gastrointestinal upset. Despite earlier promise in animal models, the trial's outcome reflects the challenges in ALS treatment development. Corcept plans to continue dazucorilant's development with a long-term study.

Corcept Therapeutics announced DAZALS study results, a Phase 2 trial for dazucorilant in ALS patients. The trial didn't meet its primary endpoint but noted fewer deaths in the dazucorilant group. An open-label extension study continues, with survival assessment in March 2025. Dazucorilant has FDA Fast Track Designation.

Corcept Therapeutics announced DAZALS study results, a Phase 2 trial for dazucorilant in ALS patients, which didn't meet its primary endpoint on ALSFRS-R change. However, the 300 mg group saw no deaths vs. 5 in placebo. The long-term extension study continues, with overall survival assessment in March 2025. Dazucorilant has FDA Fast Track Designation.

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.