CytoDyn has previously submitted applications fo

CytoDyn has previously submitted applications for Breakthrough Therapy Designation (BTD) for their drug leronlimab (PRO 140) for the treatment of metastatic triple-negative breast cancer (mTNBC).

Here is a summary of the status based on available public information:

Submissions: CytoDyn filed for BTD for leronlimab in mTNBC multiple times, including an initial filing in January 2020 and a subsequent submission or re-submission in November 2021.

FDA Response: There is no recent public confirmation that the FDA has granted the Breakthrough Therapy Designation for leronlimab for mTNBC.

Current Focus: CytoDyn continues to develop leronlimab in oncology, and recent press releases (late 2024 and 2025) focus on:

FDA clearance to proceed with a Phase 2 oncology trial for leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (mCRC).

New data analyses suggesting a novel mechanism of action for leronlimab in solid tumors, specifically in mTNBC patients.

In summary:

CytoDyn has sought Breakthrough Therapy Designation for leronlimab in mTNBC in the past, but the most recent public information available does not indicate that the designation has been granted. The company's current activities appear to be focused on advancing their Phase 2 oncology trials for other solid tumors, such as colorectal cancer, and ongoing analysis of data in mTNBC.

What is Breakthrough Therapy Designation?
Breakthrough Therapy Designation is a process created by the FDA to expedite the development and review of a drug if it is intended to treat a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate a substantial improvement over available therapies on a clinically significant endpoint.

A company must submit a formal request with supporting preliminary clinical data to the FDA for the drug and specific indication to be considered. The designation, if granted, provides for more intensive FDA guidance and an organizational commitment involving senior managers to expedite the drug's development.