CytoDyn Inc (OTCMKTS:CYDY) is having another big week leading the OTC in volume one again. CytoDyn has emerged as the biggest mover in small caps in recent months since trading as low as $0.261 back in December. The stock boats a massive fast growing shareholder base and regularly trades over $25 million in daily dollar volume.
The big story on CytoDyn is its magic bullet Leronlimab and the highly positive results that continue to come back as it is being used to treat covid patients under the U.S. Food and Drug Administration’s (FDA) emergency Investigational New Drug (eIND) program. At last count 49 covid patients have received leronlimab and this number is rapidly increasing according to CEO Nader Pourhassan, Ph.D., who expects the results from both studies to be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system.
CytoDyn Inc (OTCMKTS:CYDY) is developing treatments for multiple therapeutic indications based on leronlimab, an injectable, novel humanized monoclonal antibody targeting the CCR5 receptor, with fewer side effects, lower toxicity and less frequent doses. CytoDyn acquired leronlimab from its developer, Progenics Pharmaceuticals back in 2012. The Company has been granted a “fast-track” designation for two potential uses of leronlimab – as a combination therapy with other medications for HIV patients and for patients with metastatic triple-negative breast cancer.
Leronlimab has demonstrated significant potential as a treatment for coronavirus (COVID-19) as it inhances the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in covid patients. Leronlimab is starting to get picked up by the national media which could spell doom for the significant short position that has built up in CYDY over the past few months. There are dozens of big board biotechs looking for a coronavirus treatment but its leronlimab from CytoDyn that keeps popping up mainstream press and on TV.
— Eugene Hayman (@EugeneHayman) April 30, 2020
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This week CYDY submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA to FDA for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication. The Company announced conditional acceptance by the FDA of the proprietary name Vyrologix (pronounced – vie-ro-loj-iks) for leronlimab as a combination therapy for highly treatment experienced HIV patients in the United States. In addition, the Company has also received a notice of allowance from the U.S. Trademark Office for the Vyrologix mark.
At last count 49 covid patients have been treated with leronlimab and the results coming back continue to be very promising. In Ny where 11 patients were treated with leronlimab, Cydodyn says it believes it was able to save the lives of four patients. In California leronlimab has been used to treat 23 patients, 3 have been taking off ventilators, 8 have been discharged from the hospital and 11 patients demonstrated improvement in respiratory parameters. In George 2 of the 3 patients treated with leronlimab have been taken off ventilators and another discharged from the hosptial. Another patient in Nortern Calirfonia is now weaning from ventilator and transferred to rehabilitation hospital. Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.”
— CytoDyn (@CytoDyn) April 30, 2020
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Currently CYDY is easily among the most exciting stories in small caps and the most actively traded as the Company became one of the first biotechs to have a drug that could be effective in the global fight against coronavirus COVID-19 world epidemic. CytoDyn magic bullet leronlimab has been hailed as a possible wonder drug has been found to have significant potential to attack a host of diseases including cancer, HIV and now coronavirus COVID-19. 49 patients now with serious respiratory conditions with Covid-19 around the country are being treated with leronlimab and the results coming back are highly promising with several patients including Samantha Mottet crediting “leronlimab” for their recovery from COVID-19. The story is starting to get picked up by the national media which could spell doom for the significant short position that has built up in CYDY over the past few months. While there are dozens of big board biotechs looking for a coronavirus treatment its leronlimab from CytoDyn that keeps popping up mainstream press and on TV. In a big move this week CYDY submitted the clinical, and the CMC portions of its BLA to FDA for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.
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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.