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CytoDyn Inc. reports developments for leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor. The company is a clinical-stage oncology issuer focused on CCR5 biology in difficult-to-treat cancers, including metastatic triple-negative breast cancer and metastatic colorectal cancer.
Recurring news includes clinical and translational data presentations, Phase 2 colorectal cancer study updates, expanded access activity for triple-negative breast cancer, and preclinical work in glioblastoma. Company updates also cover financing actions used to support leronlimab development and corporate webcasts addressing scientific, operational, clinical, and financial progress.
CytoDyn Inc. (OTC.QB: CYDY) announced the release of CD12 Phase 3 trial data for leronlimab, aimed at treating critically ill COVID-19 patients. Key findings include:
- 24% reduction in all-cause mortality.
- Shortened hospital stays with a significance of p=0.0050.
- Improved discharge alive rates: 28% vs. 11%.
Statistically significant results were noted in age-adjusted analyses. The company is set to pursue further studies with regulatory consultations from the FDA and other agencies.
CytoDyn Inc. (CYDY) announced the submission of a protocol to the U.S. FDA for enrolling 140 critical COVID-19 patients in a trial. This follows the enrollment of 46 additional patients in the open-label portion of the CD12 trial. The company is also engaging with Health Canada for potential sales of leronlimab in Canada. Recent data indicate a statistically significant reduction in mortality among patients receiving leronlimab compared to placebo. CytoDyn plans to refile its Biologics License Application for HIV treatment in the first half of 2021.
CytoDyn Inc. (OTC.QB: CYDY) announced positive results from its Phase 3 trial of leronlimab for severely ill COVID-19 patients. The trial showed a 24% decrease in all-cause mortality, a 6-day reduction in hospital stays, and a 166% higher chance of being discharged alive at Day 28 compared to placebo. The company is in discussions with the FDA, MHRA, and Health Canada for potential approval. There are ongoing efforts to enroll more patients while preparing a manuscript for publication.
CytoDyn Inc. (OTC.QB: CYDY) has submitted a protocol to the U.S. FDA for the immediate enrollment of 140 critical COVID-19 patients, aiming to support a potential Emergency Use Authorization (EUA) for leronlimab. The FDA is reviewing this submission while the Company explores regulatory pathways in the U.K. and Canada. Preliminary data indicates leronlimab may significantly impact mortality rates among elderly patients. With a Fast Track designation, CytoDyn is focusing on enhancing accessibility of leronlimab for COVID-19 treatment amidst ongoing trials and regulatory discussions.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast on March 8, 2021, to discuss data from its Phase 3 trial for severe-to-critically ill COVID-19 patients. Management, including CEO Nader Pourhassan and CMO Scott Kelly, will outline the regulatory path forward across multiple countries and provide updates on clinical and corporate priorities. The webcast will allow for 90 minutes of Q&A, accessible via CytoDyn's website.
CytoDyn Inc. (OTC.QB: CYDY) announced positive results from its Phase 3 trial of leronlimab for treating critically ill COVID-19 patients. The study showed a 24% reduction in mortality and a 6-day shorter hospital stay compared to placebo. Additionally, the probability of being 'discharged alive' at Day 28 was 28% for leronlimab patients against 11% for the placebo group. The Company is in discussions with regulatory agencies to expedite approval. These outcomes highlight leronlimab’s potential as a safe and effective treatment for this vulnerable patient group.
CytoDyn Inc. (OTC.QB: CYDY) announced a new “universal shelf” registration statement on Form S-3 with the SEC, replacing the previous registration expiring on March 7, 2021. This allows CytoDyn to maintain registration of unexercised warrants and provides flexibility for future capital access. No immediate plans to offer securities exist, and no sales can occur until the registration becomes effective. The shelf registration has been active since 2016, enabling timely capital market access.
CytoDyn Inc. (OTC.QB: CYDY) has unblinded the data from its CD12 clinical trial for COVID-19 and expects to conclude discussions with regulatory agencies within 2 to 3 weeks. The trial involved 394 patients and evaluated the efficacy of Vyrologix™ (leronlimab-PRO 140). The FDA has granted leronlimab Fast Track designation for treatment of critical illnesses, including a combination therapy for HIV and metastatic triple-negative breast cancer. The company anticipates refiling its Biologics License Application in the first half of 2021.
CytoDyn (OTC.QB: CYDY) announced its collaboration with Chiral Pharma Corp. to provide 200,000 vials (100,000 doses) of leronlimab for potential sales in the Philippines, specifically targeting COVID-19 patients. The company seeks a Compassionate Special Permit (CSP) for registration, aiming to conduct trials and gather data from Philippine patients receiving the treatment. CytoDyn's Phase 2 clinical trial for COVID-19 showed significant results, with expectations to release more data soon. The FDA has granted Fast Track designation for leronlimab for critical medical conditions.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast on October 20, 2020, at 2:00 pm PT to discuss the Data Safety Monitoring Committee's recommendations following an interim analysis of 195 patients in its Phase 2b/3 clinical trial for severe-to-critical COVID-19. The webcast will feature a presentation and a Q&A session. The event is accessible via the company's website and will be archived for 30 days after the event.