CYTODYN INC. DL -,01 WKN: A0YHA5 ISIN: US23283M1018 Kürzel: 296 Forum: Aktien Thema: Hauptdiskussion

CytoDyn Files an IND and a Phase 2 Protocol with the FDA for the Treatment of NASH with Leronlimab https://www.globenewswire.com/news-release/2019/09/04/1910587/0/en/CytoDyn-Files-an-IND-and-a-Phase-2-Protocol-with-the-FDA-for-the-Treatment-of-NASH-with-Leronlimab.html

CytoDyn to Present at RHK Capital 2019 Disruptive Growth Conference Dr. Pourhassan will present on, among other things, the potential to increase leronlimab’s half-life so that it may be able to be administered only once a month, and pre-clinical study results pertaining to the potential for leronlimab to reduce liver fibrosis, which is one of the clinical manifestations of non-alcoholic steatohepatitis (NASH). https://www.globenewswire.com/news-release/2019/08/29/1908463/0/en/CytoDyn-to-Present-at-RHK-Capital-2019-Disruptive-Growth-Conference.html

CytoDyn Joins The Stock Day Podcast to Discuss Phase 3 Trials for Their HIV Program Jolly asked about the Company's plans for potential partnerships or licensing. Dr. Pourhassan shared that the Company is very close to signing a licensing agreement, which represents an important step towards the production of their HIV program. To close the interview, Jolly noted that the Company is exceptionally undervalued and represents a great opportunity for investors interested in this space. https://finance.yahoo.com/news/cytodyn-joins-stock-day-podcast-120000211.html

CytoDyn Provides Update on Dose Escalating Trial with Leronlimab for HIV Monotherapy for a Potential Pivotal Trial 564 patients have been enrolled in monotherapy trials to date with over 150 patients hitting the benchmark of one-year of sustained viral suppression The response rate post-10 weeks of monotherapy is 68% with 350 mg dose, 94% with 525 mg and 85% with 700 mg https://www.globenewswire.com/news-release/2019/08/14/1901595/0/en/CytoDyn-Provides-Update-on-Dose-Escalating-Trial-with-Leronlimab-for-HIV-Monotherapy-for-a-Potential-Pivotal-Trial.html

CytoDyn Files a Phase 2 Protocol with the FDA for Leronlimab (PRO 140) and Regorafenib as a Combination Therapy for Metastatic Colorectal Cancer This is a single arm study with 30 patients designed to test the hypothesis that the combination of leronlimab, administered as a subcutaneous injection, and Regorafenib, administered orally, will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer. “This is the third clinical program that CytoDyn has underway in the oncology space,” stated, CytoDyn President and CEO, Nader Pourhassan, Ph.D. “We recently announced the first injection in our clinical trial using leronlimab to treat metastatic triple-negative breast cancer (rmTNBC), under the supervision of Jacob Lalezari, M.D.  In addition, our Phase 1b/2 trial using leronlimab in treatment-naïve mTNBC patients is under the supervision of Massimo Cristofanilli, M.D. professor of Medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine.”    “With results from multiple pre-clinical studies in various cancer indications, including MBC and mCRC, we are optimistic about the potential of leronlimab to provide a new therapeutic option for individuals diagnosed with invasive cancer each year in the United States.  We again thank the patients who have agreed to participate in our trials and endeavor to provide each of them with clinical benefit,” concluded Dr. Pourhassan. https://www.globenewswire.com/news-release/2019/08/08/1899023/0/en/CytoDyn-Files-a-Phase-2-Protocol-with-the-FDA-for-Leronlimab-PRO-140-and-Regorafenib-as-a-Combination-Therapy-for-Metastatic-Colorectal-Cancer.html

wow... 👏🏻 bin gespannt ob das klappt Danke für die Info

CytoDyn marks major milestone for its leronlimab drug with first step into field of cancer A first patient is being treated under emergency investigational new drug regulations of the US Food and Drug Administration https://www.proactiveinvestors.com/companies/news/900209/cytodyn-marks-major-milestone-for-its-leronlimab-drug-with-first-step-into-field-of-cancer-900209.html

Dann drücken wir mal die Daumen dass das persönliche Treffen was bringt ✊🏻

CytoDyn Granted Small Business Waiver of Application Fees by FDA for Leronlimab (PRO 140) BLA Filing “We are extremely grateful to the FDA for granting the fee waiver,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “Our goal firmly remains to complete in September 2019 the BLA filing with the FDA for leronlimab as a combination therapy with HAART for HIV-infected patients and hopefully initiate our first monotherapy pivotal trial for label expansion soon after our in-person meeting with the FDA,” continued Dr. Pourhassan. “We are also hopeful to initiate our funded PrEP clinical trial this year, which will be conducted in Thailand.” https://www.cytodyn.com/newsroom/press-releases/detail/347/cytodyn-granted-small-business-waiver-of-application-fees

CytoDyn Sponsored Research Reaffirms the Role of CCR5 in Cancer Biology and Provides a New Potential Cancer Treatment Modality Exciting results from Daniel Lindner, M.D., Ph.D. at the Cleveland Clinic with leronlimab on human colon carcinoma https://www.globenewswire.com/news-release/2019/08/02/1896197/0/en/CytoDyn-Sponsored-Research-Reaffirms-the-Role-of-CCR5-in-Cancer-Biology-and-Provides-a-New-Potential-Cancer-Treatment-Modality.html

CytoDyn Executes Exclusive Worldwide Licensing Agreement with IncellDX for PA-14 and PRO 140 for Diagnostic Testing Purposes Agreement represents a revenue opportunity as a diagnostic test for receptor occupancy and the existence of CCR5 on cancer tissue and in HIV https://www.globenewswire.com/news-release/2019/07/26/1892175/0/en/CytoDyn-Executes-Exclusive-Worldwide-Licensing-Agreement-with-IncellDX-for-PA-14-and-PRO-140-for-Diagnostic-Testing-Purposes.html

Das klingt nach einem guten Verlauf und das es noch ein bisschen dauert, aber es bewegt sich was in die richtige Richtung 👍🏻 Danke Schorsch 👏🏻

CytoDyn Finalizes Development of Receptor Occupancy Test to Guide Pivotal Monotherapy Discussions With the FDA GlobeNewswireJuly 25, 2019, 12:00 PM GMT+2 -       FDA face-to-face meeting granted to discuss pivotal monotherapy trial -       Conference call for investors and media on Tuesday, July 30, 2019 at 4:00 p.m. ET with introduction to Dr. Jonah Sacha for CURE and PrEP programs, Dr. Bruce Patterson for CCR5 receptor occupancy for HIV and cancer, and Dr. Jacob Lalezari for TNBC trial https://finance.yahoo.com/news/cytodyn-finalizes-development-receptor-occupancy-100000939.html

TipTop, merci

👍Danke Schorsch

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