CytoDyn to submit leronlimab application questions to FDA; gets nod from UK regulators to proceed with coronavirus trial

CytoDyn Inc (OTCQB:CYDY) has announced a pair of regulatory advancements for its drug leronlimab as a treatment for HIV and the coronavirus (COVID-19) both in the US and across the pond.  The company said it will submit questions regarding its Biologics License Application (BLA) for leronlimab to the US Food and Drug Administration in writing instead of holding a virtual Type A meeting. The FDA has agreed to respond to said questions by September 4. The questions concern the additional information that the FDA requires to resubmit CytoDyn’s BLA for leronlimab as a combination therapy for HIV. READ: CytoDyn requests fast track approval for leronlimab from UK regulators to treat coronavirus patients “We completely understand and appreciate the FDA’s meeting schedule during these unprecedented times and are eager to discuss and provide all additional information regarding our recent BLA filing,” CEO Nader Pourhassan said in a statement. “Our questions to the FDA were submitted on a Type A meeting request and the Agency’s response to those questions will ensure we have the necessary information we need to resubmit the BLA as soon as possible.” In the UK, the clinical trials unit of the country’s Medicines & Healthcare product Regulatory Agency (MHRA) authorized CytoDyn to enroll patients in its ongoing Phase 3 trial of leronlimab in severe-to-critical coronavirus patients.  “We are very pleased with the MHRA’s confidence in leronlimab to initiate enrollment of patients in the UK for our current CD12 protocol,” Pourhassan said. “CytoDyn recently requested fast track approval from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data.” CytoDyn recently completed a Phase 2 trial of leronlimab in mild-to-moderate coronavirus patients. Participants who received leronlimab were more than twice as likely to experience an improvement in National Early Warning Score after two weeks than those who received a placebo. “We believe leronlimab has multiple opportunities for several clinical indications and we are very optimistic about our future based upon how far we have advanced this drug in about five years. In addition, we plan to file a BLA for HIV in the UK within the next four weeks,” Pourhassan said.  Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel