CYDY - CytoDyn Inc.

Other OTC - Other OTC Delayed Price. Currency in USD
0.4350
-0.0175 (-3.87%)
At close: 3:57PM EDT
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Previous Close0.4525
Open0.4571
Bid0.0000 x 0
Ask0.0000 x 0
Day's Range0.4300 - 0.4572
52 Week Range0.0600 - 0.7100
Volume740,723
Avg. Volume473,120
Market Cap136.821M
Beta (3Y Monthly)0.90
PE Ratio (TTM)N/A
EPS (TTM)-0.2070
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est1.50
Trade prices are not sourced from all markets
  • ACCESSWIRE11 days ago

    The Stock Day Podcast Hosts CytoDyn to Discuss the Addition of Dr. Jonah Sacha to their Team

    PHOENIX, AZ / ACCESSWIRE / July 10, 2019 / The Stock Day Podcast welcomed CytoDyn (CYDY) (“the Company”), a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CEO and President, Nader Pourhassan, Ph.D., joined Stock Day host Everett Jolly. Jolly began the interview by asking about the Company’s recent press release regarding a new addition to their team.

  • GlobeNewswire13 days ago

    CytoDyn Names Dr. Jonah Sacha as its Senior Science Advisor to Explore Leronlimab (PRO 140) Potentials in HIV Pre-Exposure Prophylaxis (PrEP) and Cure

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications today announced the appointment of Dr. Jonah Sacha, Ph.D. as Senior Science Advisor to the Company.  Dr. Sacha will lead the development of leronlimab (PRO 140) as a potential therapeutic for HIV Pre-Exposure Prophylaxis (PrEP) and HIV cure.  Dr. Sacha is an expert in HIV/AIDS research who serves on the National Institutes of Health Office of AIDS Research Advisory Council and leads a research laboratory in the Vaccine and Gene Therapy Institute and Oregon National Primate Research Center at the Oregon Health & Science University. The Sacha laboratory aims to identify novel therapeutic approaches for use in prophylactic HIV vaccines and HIV-remission inducing treatments.

  • GlobeNewswire20 days ago

    CytoDyn Anticipates Revenue Commencing in August 2019 from Use of PA-14 and/or PRO 140 in Diagnostic Test

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications today announced a non-binding agreement with IncellDX, Inc. for a diagnostic license and supply agreement for the PA-14 antibody (the diagnostic designation of the murine version of PRO 140) and PRO 140, which is humanized PA-14.  Assays to determine the existence of CCR5 on cancer tissue and the receptor occupancy level for HIV patients are believed to be integral for the effective introduction of leronlimab for therapeutic benefits in this patient population. “Our non-binding agreement with IncellDX, subject to execution of a definitive agreement, which is expected to be finalized in July 2019, may lead to our first ever product revenues,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D.  “Importantly, the PRO 140 used for the PA-14 diagnostic test is non-commercial grade product in storage.  As such, this transaction allows CytoDyn to potentially realize significant value from product that would have very likely been discarded,” continued Dr. Pourhassan.  “Each diagnostic test may use 20 micro mg (mcg) of PRO 140 (1 mg = 1,000 mcg), implying significant revenue opportunity for CytoDyn, since any use of leronlimab for commercial purposes will require this diagnostic test.  Bottom line, this is a small first step in realizing full value from PRO 140,” concluded Dr. Pourhassan.

  • GlobeNewswire27 days ago

    FDA Grants Face-to-Face Meeting to Discuss CytoDyn’s 510(k) Application for ProstaGene™ Prognostic Test

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications today announced that the Center for Devices and Radiological Health (“CDRH”) of the U.S. Food and Drug Administration (“FDA”) has received CytoDyn’s previously announced submission of the 510(k) application for clearance of the ProstaGene™ Prognostic Test.  CDRH has granted CytoDyn a face-to-face meeting to discuss the application on August 28, 2019.  The ProstaGene™ Prognostic Test is intended for use in patients who have undergone a prostate biopsy and been found to have prostate cancer by the Gleason score. “We are extremely grateful to the FDA for the timely action date on our recently filed 510(k) application for clearance of the ProstaGene™ Prognostic Test,” stated Dr. Nader Pourhassan, Ph.D., President and CEO of CytoDyn.  “The ProstaGene™ Prognostic Test holds the potential to aid patients and physicians in better decision-making,” continued Dr. Pourhassan.  “We eagerly look forward to working with the FDA to ensure that we continue to develop the ProstaGene™ Prognostic Test to the highest standards of the FDA and solidify our potential commercialization alternatives, including potentially value accretive partnerships,” concluded Dr. Pourhassan.

  • GlobeNewswirelast month

    CytoDyn Submits 510(k) Pre-Submission Application to U.S. FDA for ProstaGene™ Prognostic Test

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the filing of a pre-submission application for a meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the 510(k) application for FDA clearance of the ProstaGene™ Prognostic Test.  The ProstaGene™ Prognostic Test is intended for use in patients who have undergone a prostate biopsy and been found to have prostate cancer by the Gleason score.  The ProstaGene™ Prognostic Test was developed by Dr. Richard Pestell, A.O., M.D., Ph.D., F.A.C.P., M.B.A., CytoDyn’s Chief Medical Officer. The test became an asset of CytoDyn upon its acquisition in November 2018 of ProstaGene, a biotechnology company founded by Dr. Pestell.

  • GlobeNewswirelast month

    CytoDyn Announces Major Discovery for its Monotherapy Indication

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today significant progress in securing the therapeutic effect and safety of leronlimab (PRO 140) with the development of an assay that can reliably determine a patient’s CCR5 status.  Currently, all new patients in the Company’s monotherapy trial are being evaluated with this newly developed screening-level test with the objective of identifying patients expected to respond to a monotherapy versus those not expected to respond due to CCR5  density. “The development and implementation of an assay that can rapidly and accurately identify potential responders to leronlimab offers a tremendous technical advancement with the potential to more precisely target leronlimab on patients most likely to respond to treatment,” stated Dr. Nader Pourhassan, President and CEO of CytoDyn.  “We are excited about our partnership with IncellDx to provide the technical support to explore the power and potential of CCR5 inhibition,” continued Dr. Pourhassan.

  • GlobeNewswirelast month

    CytoDyn Signs Groundbreaking Memorandum of Understanding with Thai Red Cross AIDS Research Centre to Study Pre-Exposure Prophylaxis Use of Leronlimab (PRO 140) in People at High Risk of Acquiring HIV

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a Memorandum of Understanding (“MOU”) with Thai Red Cross AIDS Research Centre (“TRCARC”) for the design and conduct of a pre-exposure prophylaxis (PrEP) clinical trial of leronlimab (PRO 140) in subjects at high risk of HIV infection. CytoDyn’s financial contribution to this trial will be limited to supplying TRCARC with the necessary quantities of leronlimab. TRCARC will secure all necessary regulatory permissions, and ensure that the PrEP trial is conducted in a timely manner under mutually agreed upon clinical trial protocols.

  • GlobeNewswirelast month

    CytoDyn Raises over $12 Million in New Capital from Private and Public Warrant Offers in the Last Five Weeks with Minimum Dilution

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications announced today that it raised approximately $9.1 million from its recently completed public warrant tender offer. “In addition to these developments, CytoDyn is about to enter the world of cancer therapeutics with the long-awaited first patient injection for TNBC approaching.

  • GlobeNewswirelast month

    CytoDyn to Present Pivotal Data at ASM Microbe 2019 Demonstrating Efficacy and Safety of Leronlimab (PRO 140) in HIV Patients with Multiple ARV Class Resistance

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications announced it will present final results of the Phase 3 pivotal clinical trial of leronlimab (PRO 140) as a combination therapy with HAART for heavily treatment experienced HIV patients at the 2019 American Society for Microbiology (ASM) Microbe Conference. The ASM Microbe Conference will be held June 20 – 24 at the Moscone Center in San Francisco.  ASM Microbe 2019 is the main forum for microbial sciences and considers and debates scientific issues, connects scientists and explores the complete spectrum of microbiology from basic science to translation and application.  CytoDyn’s management team will be available for investor and industry meetings throughout the duration of the conference.  Please direct meeting requests to: Marek Ciszewski, J.D. at mciszewski@edisongroup.com.

  • GlobeNewswirelast month

    CytoDyn and FDA Will Meet to Potentially Finalize Protocol for Pivotal Monotherapy Trial for Leronlimab

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announces that the U.S. Food and Drug Administration (“FDA”) has requested an in-person meeting to discuss and potentially finalize the Company’s recently submitted protocol for a pivotal monotherapy trial with leronlimab.  The Company will announce further details when available. “The potential role of the CCR5 co-receptor in the prevention of and cure for HIV has been very well documented and has been the subject of major media attention,” added Dr. Pourhassan.

  • GlobeNewswire2 months ago

    CytoDyn to Present at the 9th Annual LD Micro Invitational Conference on June 5

    VANCOUVER, Washington, May 30, 2019 -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5.

  • GlobeNewswire2 months ago

    CytoDyn to Hold Investment Community Conference Call on May 20, 2019

    VANCOUVER, Washington, May 16, 2019 -- CytoDyn Inc. (OTC.QB: CYDY) announces that Nader Pourhassan, Ph.D., President and Chief Executive Officer, and Richard Pestell, M.D.,.

  • GlobeNewswire2 months ago

    CytoDyn Files Pivotal Trial Protocol for HIV Monotherapy with FDA

    CytoDyn Inc. (CYDY), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has filed with the U.S. Food and Drug Administration (FDA) the pivotal trial protocol for leronlimab as a monotherapy for HIV patients.  The latest investigative monotherapy trial for HIV has now produced sufficient data for the Company’s Key Opinion Leaders to design a monotherapy pivotal Phase 3 trial. The objective of this trial is to assess the treatment strategy and clinical safety of using leronlimab subcutaneous (SC) 700mg weekly dose as single-agent induction therapy followed by leronlimab SC 525 or 700mg as maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

  • GlobeNewswire2 months ago

    CytoDyn Strengthens Management Team with Key Additions in Business Development and Quality Regulatory Compliance as it Advances Commercialization Plan for Leronlimab

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the hiring of Brendan Rae, Ph.D., J.D., as Senior Vice President of Business Development and George Bitar as Executive Director - Head of Quality.  The addition of these senior positions aligns with CytoDyn’s pursuit of strategic partnership agreements and efforts to attain its first FDA approval. Mr. Bitar will be responsible for overseeing all facets of the company’s Quality Systems, Quality Assurance, and Compliance Operations to ensure that product is manufactured consistently to meet all FDA standards.  As CytoDyn enters into a new era of manufacturing partnerships with contract manufacturing organizations (CMOs) in preparation for post-approval product launch of leronlimab, a knowledgeable Head of Quality is a critical component of the BLA approval and the commercialization process.  Mr. Bitar brings to CytoDyn over 25 years in quality management, technical operations, pharmaceutical manufacturing and R&D, including most recently as the Global Head of Quality at Hitachi Chemical Advanced Therapeutics Solutions, a cellular and gene therapy contract development and manufacturing organization.  Previously, Mr. Bitar led Pfizer’s generic oncology and biosimilars manufacturing through the approval process and was the Site Head of Quality for Pfizer’s specialty injectable and biologic drug products.  Prior to Pfizer, Mr. Bitar was Vice President – Head of Quality at InnoPharma Inc., which was acquired by Pfizer.   Mr. Bitar earned an M.S. in Pharmaceutical Chemistry with Honors from Seton Hall University and a B.Sc.

  • GlobeNewswire2 months ago

    CytoDyn Initiates Pre-Clinical Study of Leronlimab (PRO 140) to Prevent NASH with The Cleveland Clinic’s Dr. Daniel J. Lindner, M.D., Ph.D.

    VANCOUVER, Washington, May 13, 2019 -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5.

  • GlobeNewswire2 months ago

    CytoDyn Provides Updated Pre-Clinical Data Showing Leronlimab (PRO 140) Continues to Suppress Breast Cancer Metastatic Burden 98% Compared with Untreated Animals

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announces that in a murine xenograft human breast cancer metastatic model, after 9 weeks, compared with untreated mice at 8 weeks, the leronlimab treated mice continued to have a 98% reduction in metastatic burden.  Moreover, to test the ability of leronlimab to fight high tumor burden models, four of the mice in the control group with advanced metastatic disease, were treated with leronlimab.  Two of these four mice were still alive at week 16. “We anticipate presenting the findings at an appropriate medical conference and publish the results,” said Dr. Pestell.  “Should our mouse xenograft breast cancer metastasis studies using leronlimab correlate in humans, leronlimab may offer paradigm-shifting treatment options for metastatic cancer patients,” continued Dr. Pestell.  “We look forward to interim data from our first human trial in mTNBC this year that will inform our future development and regulatory strategy,” concluded Dr. Pestell.

  • GlobeNewswire2 months ago

    FDA Grants CytoDyn Fast Track Designation for Leronlimab (PRO 140) in metastatic Triple-Negative Breast Cancer, an Unmet Medical Need

    VANCOUVER, Washington, May 07, 2019 -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5.

  • GlobeNewswire2 months ago

    CytoDyn’s Monotherapy Trial with Leronlimab (PRO 140) Reaches its Ultimate Goals

    New data shows 525 mg dose achieves 95% response rate after the first 10 weeks of monotherapy with leronlimabOver 110 patients have reached almost one year of suppressed viral.

  • GlobeNewswire3 months ago

    CytoDyn to Present at ThinkEquity Conference on May 2, 2019

    VANCOUVER, Washington, April 29, 2019 -- CytoDyn Inc. (OTC.QB: CYDY), CytoDyn, a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the.

  • GlobeNewswire4 months ago

    ASM Microbe 2019 Conference Grants Both Poster and Oral Presentations to CytoDyn for its Pivotal Study of Leronlimab (PRO 140) which Demonstrated Superior Efficacy and Safety in Heavily Treatment-Experienced HIV Patients

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has been selected to present final results of the pivotal study of leronlimab (PRO 140) in heavily treatment-experienced HIV patients infected with CCR5-tropic HIV-1 at the 2019 American Society for Microbiology (ASM) Microbe Conference.  The company has been selected for oral and poster presentations.

  • GlobeNewswire4 months ago

    CytoDyn and Samsung BioLogics Enter into Agreement to Manufacture $1 Billion Worth of Leronlimab (PRO 140) to Meet Expected Demand for Future Revenues Post-Approval

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the execution of a comprehensive strategic agreement with Samsung BioLogics Co., Ltd. for the clinical and commercial manufacturing of leronlimab (PRO 140). The quantity of new leronlimab to be produced under the agreement is anticipated to be sufficient to support potential revenues for CytoDyn of approximately $1 billion based upon $120,000 per patient, per year. The agreement commences immediately and entails, most notably, technology transfer of the fully validated commercial process and scale-up, large scale commercial production, validation, and regulatory support during the pre- and post- approval process with the U.S. Food and Drug Administration (FDA) and other global regulatory bodies.  In the last four years, Samsung BioLogics has secured 8 biologics drugs approvals from the FDA and 22 overall when including other agencies around the world.

  • Reuters4 months ago

    S.Korean stocks rise for 3rd session as risk appetite improves

    Round-up of South Korean financial markets: ** South Korea's KOSPI stock index gained for a third consecutive session on Tuesday on positive manufacturing data from the world's top two economies. The won ...

  • GlobeNewswire4 months ago

    CytoDyn Announces Data From Two Studies at the AACR Annual Meeting

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, highlighted two studies that will be presented on April 1st at the American Association of Cancer Research (AACR) Annual Meeting taking place March 29 to April 3 in Atlanta, Georgia. The first study will present data showing the expression of CCR5 in circulating tumor cells (CTCs) of HER2 metastatic breast cancer (mBC) patients and documents the correlation between CCR5 and HER2 expression in CTCs.  The second study will highlight murine xenograft data showing that CytoDyn’s humanized monoclonal antibody, leronlimab (PRO 140), can effectively block human breast cancer metastases and enhance the cell killing ability of DNA damaging chemotherapy by selectively targeting the CCR5 receptor.

  • GlobeNewswire4 months ago

    CytoDyn’s Monotherapy Trial with Leronlimab (PRO 140) Exceeds Expectations

    50 patients in 350 mg dose arm have reached about 1 year of monotherapy with 6 patients passing 4.5 years (on extension study). VANCOUVER, Washington, March 26, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that new data shows that a weekly dose of 525 mg and 700 mg of leronlimab yielded approximately a 90% response rate for those HIV-infected patients who pass the first 10 weeks of monotherapy without virologic failure.

  • GlobeNewswire4 months ago

    CytoDyn Reaches Historical Milestone, Submits First of Three Sections of BLA to FDA for Leronlimab (PRO 140) as a Combination Therapy for HIV

    CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has filed with the U.S. Food and Drug Administration (FDA) the non-clinical portion of its Biologics License Application (BLA) using the FDA’s Rolling Review process.  The non-clinical portion constitutes the first of three sections of the BLA submission for leronlimab (PRO 140) as a combination therapy with HAART for HIV-infected patients. The FDA previously granted Fast Track Designation (FTD) and recently granted Rolling Review for leronlimab (PRO140), which facilitates frequent interactions with the FDA review team.