Quote:AI Overview
Based on the drug approved in that timeframe it is not Leronlimab.
The drug approved on February 26, 2026, 44 days after its filing date, is zongertinib (brand name Hernexeos).
Here are the details regarding the February 26, 2026, approval:
Drug: Zongertinib (Hernexeos).
Indication: First-line treatment for adults with HER2-mutated non-squamous non-small cell lung cancer (NSCLC).
Filing Date: January 13, 2026.
Approval Date: February 26, 2026 (44 days later).
Program: FDA Commissioner's National Priority Voucher (CNPV) pilot program.
Leronlimab Status:
Leronlimab is an investigational CCR5 antagonist being developed by CytoDyn for various conditions, including HIV, metastatic triple-negative breast cancer, and potentially COVID-19. As of early 2026, it is involved in an Expanded Access Program (EAP) scheduled for March 2026, not a rapid 44-day approval for lung cancer.
Nice to know that kind of approval can come in such a short time.