Leronlimab

Jose Goyos sentenced to 15 years for managing a $67M Medicare fraud scheme involving medically unnecessary genetic tests. Nader Pourhassan and Kazem Kazempour convicted of securities fraud for deceiving investors regarding CytoDyn’s FDA submissions. Dr. Basem Hamid pays $948,359.85 to settle false Medicare claims for neurostimulator implants.

Former CytoDyn CEO Nader Pourhassan found guilty of lying to investors about experimental drug leronlimab, profiting from its promoted potential for HIV, cancer, and COVID-19 treatments.

Two CEOs, Nader Pourhassan and Kazem Kazempour, were convicted for defrauding investors about a drug being developed to treat HIV and COVID-19. They enriched themselves by millions with false promises of FDA approval, leading to investor losses. Pourhassan and Kazempour were accused of lying about the timeline and status of regulatory submissions to the FDA.

Two men, Nader Pourhassan and Kazem Kazempour, were convicted for deceiving investors about CytoDyn’s drug development to inflate stock prices. They made false statements about FDA approval timelines, sold shares at inflated prices, and raised $300 million from investors. Pourhassan and Kazempour face up to 20 years in prison for securities fraud, wire fraud, and insider trading.

November 2024 saw numerous FDA approvals, designations, and clinical trial advancements in oncology, including revumenib for KMT2A-rearranged acute leukemia, obe-cel for relapsed/refractory B-cell ALL, and fast track designations for ALE.P02 in Claudin-1-positive tumors. Other highlights include orphan drug designations for LBL-024 in neuroendocrine cancer and elraglusib in Ewing sarcoma, and a new drug application for sunvozertinib in EGFR-mutant NSCLC.

CytoDyn appoints Richard Pestell, M.D., Ph.D., as Lead Consultant in Oncology to advance leronlimab's clinical development in cancer treatment.

DelveInsight's report on Nonalcoholic Steatohepatitis (NASH) provides insights into historical and forecasted epidemiology, market trends, current treatment practices, emerging drugs, and market size from 2019 to 2032 in the United States, EU5, and Japan. Key companies and therapies in the NASH market are highlighted, including recent developments like Aligos Therapeutics' Phase 1 data presentation.

CytoDyn finalized a phase 2 study protocol for leronlimab in relapsed/refractory microsatellite stable colorectal cancer, gaining FDA clearance. The trial, in partnership with Syneos Health, is set to start in November 2024, with patient enrollment in early 2025. Leronlimab, combined with TAS-102 and bevacizumab, targets CCR5+ MSS mCRC patients who have undergone multiple treatments.

CytoDyn Inc. received FDA clearance for a phase II oncology trial evaluating leronlimab in r/r microsatellite stable colorectal cancer. The trial, in partnership with Syneos Health, will begin patient enrollment in early 2025.