Cytodyn Inc Stock Price, News & Analysis

CytoDyn Inc. announced that Health Canada has authorized the emergency use of leronlimab for treating metastatic triple-negative breast cancer (mTNBC). CEO Nader Pourhassan expressed optimism about the approval, highlighting the potential for expanded access for other mTNBC patients. The company plans to pursue similar approvals in other countries, including the U.S. CytoDyn is also looking to resubmit its Biologics License Application for HIV treatment following previous setbacks. Leronlimab targets the CCR5 receptor and has shown promise in clinical trials for various indications.

CytoDyn Inc. (OTCQB: CYDY) has announced the adjournment of its 2021 Annual Meeting of Stockholders to November 24, 2021, at 8:00 a.m. Pacific Time. Stockholders must register 24 hours before the meeting. The management team will outline the company's strategy for the coming year. CytoDyn is developing leronlimab, a CCR5 antagonist, with indications across multiple therapeutic areas, including HIV and COVID-19. The firm is also resubmitting its Biologics License Application (BLA) for HIV treatments, with expectations for completion in Q1 2022.

CytoDyn Inc. (OTCQB: CYDY) has announced the initiation of its Biologics License Application (BLA) resubmission for HIV, guided by the FDA. The current phase involves submitting non-clinical and CMC sections, with the clinical section expected in Q1 2022. CEO Nader Pourhassan expressed optimism over progress, noting patients from the CD02 trial have achieved prolonged viral load suppression. The company is also preparing to file for expanded access to leronlimab for urgent cases. CytoDyn is focused on addressing previous BLA issues and exploring further clinical trials for various conditions.

CytoDyn Inc. (OTCQB: CYDY) announced it submitted a Breakthrough Therapy designation application to the FDA for leronlimab as a treatment for metastatic triple-negative breast cancer (mTNBC). This application is based on positive findings from a study involving 28 patients who had failed multiple treatments. Key results show a median overall survival of 12+ months for those on higher doses of leronlimab, exceeding traditional treatment options. The CEO expressed hope for improved patient outcomes and anticipates FDA feedback before year-end.

CytoDyn Inc. (OTCQB: CYDY) announced updated results from its ongoing cancer study using leronlimab for treating 28 patients with CCR5+ Metastatic Triple-Negative Breast Cancer (mTNBC). The updated analysis shows a 3600% increase in 12-month Overall Survival (OS) and a 580% increase in 12-month Progression Free Survival (PFS). CEO Nader Pourhassan stated that they are preparing a Breakthrough Therapy application to the FDA. Leronlimab holds Fast Track designation for HIV and mTNBC, with several ongoing clinical trials targeting various conditions.

CytoDyn Inc. (OTCQB: CYDY) announced preliminary results from its Phase 2 trial of leronlimab for treating nonalcoholic steatohepatitis (NASH). Findings from five patients indicated reductions in fatty deposits by up to 45% and fibrosis by 10% in four out of five patients. The trial aims to show if leronlimab can inhibit liver fibrosis in NASH. The company plans to submit a Breakthrough Therapy designation application and expects more data in December. Currently, there are no FDA-approved treatments for NASH, affecting 3-12% of U.S. adults.

CytoDyn Inc. (OTCQB: CYDY) announced that its 2021 Annual Meeting of Shareholders was convened and subsequently adjourned due to the absence of a quorum, attributed to the activist group led by Paul Rosenbaum and Bruce Patterson failing to submit proxies. The meeting is rescheduled for November 24, 2021, to allow further proxy solicitation. Shareholders are urged to vote using the provided BLUE proxy card. CytoDyn continues its efforts to advance clinical trials for leronlimab, targeting various therapeutic uses including HIV and cancer.

CytoDyn Inc. (OTCQB: CYDY) has announced the FDA's acceptance of its revised "Rolling Review" timeline for the resubmission of its Biologics License Application (BLA) for leronlimab, targeted at highly treatment-experienced HIV patients. The Company expects to resubmit the non-clinical and CMC sections in November 2021, with the clinical section anticipated in early 2022. Leronlimab aims to serve multiple indications, including HIV and metastatic triple-negative breast cancer, having shown significant promise in clinical trials.

CytoDyn Inc. (OTCQB: CYDY) has initiated its pivotal Phase 3 trial (CD16) for critically ill COVID-19 patients in Brazil, treating the first patient recently. An interim analysis will assess outcomes after 127 patients are enrolled. The trial focuses on patients needing mechanical ventilation and utilizes leronlimab, a CCR5 antagonist. Compared to prior trials, new dosing methods via IV could enhance drug absorption. The company aims to file for Emergency Use Authorization after promising initial results from prior studies indicate significant survival benefits.