CytoDyn Stock Moves Higher Amid FDA News

Late-stage company CytoDyn Inc. (CYDY) announced that it has submitted a letter to the US Food and Drug Administration for the approval of leronlimab, a drug for the treatment of patients with mTNBC. CYDY stock price is at $1.16 in the market, moving 1.75% higher compared to the previous session. The company’s Chief Medical Officer showed early research data from the study at the Triple-Negative Breast Cancer Digital Summit. Dr. Nitya Ray led the team that worked on the project.

The data from these studies were collected from 28 patients with mTNBC who received 1 dose of leronlimab subcutaneously in combination with standard of care. All subjects were followed for at least 3 months. The median progression-free survival was 52 years in the higher dose cohort and 1.8 years in the lower dose group.

The LifeTracDx™ liquid biopsy algorithm was used to evaluate the response of patients with leronlimab-refractory non-small cell lung cancer. It uses three different parameters to measure the changes in cancer-associated macrophage-like cells (CAML) and CTCs. The data package supporting the company’s application for Breakthrough therapy designation for leronbalab for the treatment of mTNBC is strong evidence that this treatment could provide patients with a new therapeutic option.