Cytodyn Inc Stock Price, News & Analysis

CytoDyn Inc. (OTCQB: CYDY) announced key management appointments, including Dr. Christopher Recknor as Senior Executive VP of Clinical Operations and Dr. Nitya Ray as Chief Operating Officer. This restructuring aims to streamline the BLA resubmission process and advance clinical development for leronlimab, a CCR5 antagonist with potential applications in HIV and cancer. The company is also preparing for upcoming trials, including for NASH and COVID-19 long-haulers. Dr. Ray's experience is expected to enhance regulatory submissions, while a strong inventory of leronlimab supports commercial readiness.

CytoDyn Inc. (OTCQB: CYDY) has filed a lawsuit against NSF International and Amarex Clinical Research for breach of contract, alleging failure to provide agreed services and significant delays in obtaining regulatory approval for its investigational drug, leronlimab. CytoDyn claims these failures have resulted in substantial damages and avoidable delays in clinical development. The company has simultaneously initiated arbitration to seek a resolution. Meanwhile, CytoDyn plans to resubmit its Biologics License Application (BLA) by early 2022, with upcoming trial submissions expected in November.

CytoDyn Inc. (OTC-PINK: CYDY) responds to an activist group's plan, asserting it lacks compelling strategic direction for cancer therapy approval. The company emphasizes its progress in developing leronlimab, a CCR5 antagonist, achieving faster advancements than prior ownership. Key points include support from top oncologists, a focus on Breakthrough Therapy designation, and a recent Phase 3 trial clearance in Brazil for IV treatment. CytoDyn warns shareholders against the activist group's misleading statements and conflicts of interest, advising no immediate action.

A group of long-time stockholders of CytoDyn Inc. (CYDY) has nominated five director candidates and released a white paper criticizing the company's borrowing practices. Since June 2018, CYDY has relied heavily on borrowing from Iliad Research and Trading, resulting in $142.5 million of convertible notes yielding only $125 million due to high costs. The group calls for accountability from current management, asserting the need for competent leadership to restore investor trust and maximize the company's potential.

CytoDyn Inc. (OTCQB: CYDY) announced a comprehensive business update to be presented by CEO Nader Pourhassan and CMO Scott Kelly at the Emerging Growth Conference on September 29, 2021. The presentation will last 20 minutes, followed by 40 minutes of Q&A.

CytoDyn is developing leronlimab, a CCR5 antagonist with potential uses in treating HIV, cancer, and post-COVID-19 symptoms. The FDA has granted Fast Track designation for two indications related to HIV and metastatic cancer. Phase 2 trials for NASH and long COVID are also underway.

A group of long-time stockholders of CytoDyn Inc. (OTC: CYDY) has announced a strategic plan to secure FDA approval for Leronlimab, a cancer therapy. They have nominated five experienced candidates for the Board, asserting that the current management's approach is ineffective. The plan aims to leverage precision medicine data, combine therapies, prioritize cancer targets, and partner with leading oncology companies. The Group believes this strategy could generate revenue and enhance shareholder value, urging stockholders to vote for their nominees on the WHITE proxy card.

CytoDyn (OTC-PINK: CYDY) has received approval from Brazil’s ANVISA to commence an additional Phase 3 CD16 clinical trial for leronlimab, targeting critically ill COVID-19 patients requiring mechanical ventilation. The trial aims to enroll 316 patients across 22 centers, with an interim analysis planned after 40% enrollment. CytoDyn's CEO highlighted the advantages of IV administration of leronlimab over subcutaneous methods used previously. With a primary endpoint of recovery time, the study builds on previous findings showing significant survival benefits in the critically ill.

CytoDyn, a late-stage biotechnology company, announced that Dr. Scott Kelly will present at the World Antiviral Congress from November 30 to December 2, 2021, in San Diego. His talk, scheduled for November 30 at 2:55 PM PDT, will focus on leronlimab, a CCR5 antagonist with potential applications in treating HIV, COVID-19, and related conditions. Dr. Kelly emphasized the significance of leronlimab’s potential in antiviral therapy, highlighting CytoDyn's ongoing clinical trials and resubmission efforts with the FDA for HIV treatment.

A group of long-time stockholders of CytoDyn Inc. (OTC: CYDY) has announced their commitment to a proxy contest to elect five director candidates to the Board. Judge Maryellen Noreika approved the dismissal of CYDY’s lawsuit aimed at preventing stockholders from voting for these candidates. The stockholders argue that ending the litigation will conserve corporate resources amid dwindling finances due to past management issues. A separate litigation in Delaware remains pending to ensure stockholder voting rights for the nominated candidates.