CytoDyn shares jump as it submits leronlimab license application to FDA; names Mulholland as interim finance chief

CytoDyn Inc (OTCQB:CYDY) said it reached a milestone Monday, namely its submission to the FDA of the final two parts required to license leronlimab as a combination therapy with highly active antiretroviral therapy (HAART) for HIV patients, who are highly treatment experienced. The move marks CytoDyn's transition from a development-stage company to a commercial organization, said Nader Pourhassan, president and CEO of CytoDyn. READ: CytoDyn Inc’s first patient treated with flagship drug leronlimab in Phase 2b/3 trial for coronavirus "We are excited about the opportunity to introduce a novel therapeutic to HIV patients. Monday also saw the biotech firm report that Michael D Mulholland had been hired as interim chief financial officer. He most recently served as executive advisor to the CEO and senior vice president of finance. Investors responded well, sending shares nearly 11% higher to $3.54 in morning trade.  The final parts of the Biologics License Application (BLA) were the clinical,and the CMC (chemistry, manufacturing and controls) portions. Dr Pourhassan said once the ongoing investigative trial for leronlimab as a once-weekly monotherapy for HIV-infected patients had reached its objectives, the firm plans to initiate a registration-directed study. "Leronlimab’s strong safety profile demonstrated in eleven clinical trials with over 800 people supports its long-term potential," said Dr Pourhassan.. "With the BLA filing for a combination therapy now complete, we are continuing our efforts on commercialization-readiness, as well as advancing leronlimab in the other important therapeutic areas of COVID-19, cancer and immunology," he added. The FDA has granted 'Fast Track' status to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second for metastatic triple-negative breast cancer. Also on Monday, in  a separate statement, CytoDyn said the FDA had conditionally approved the proprietary name Vyrologix for leronlimab as a combination therapy for highly treatment experienced HIV patients in the USA and that it had also received the green light from the US trademark office for the Vyrologix mark. Final approval, however, of Vyrologix as the proprietary name for leronlimab is conditional on FDA approval of the Biologics License Application and new drug application. On Mulholland's return to a senior leadership role at the company, Dr Pourhassan also said in the statement: "His deep experience and knowledge will help us navigate through the myriad of opportunities before us and assist our team to maximize shareholder value." Contact the author at giles@proactiveinvestors.com