Shares of CytoDyn Inc. ((CYDY - Free Report) ) grew 20% after it announced the signing of a Memorandum of Understanding (MOU) with the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) to conduct a COVID-19 study on its investigational candidate, leronlimab. The study will be conducted for severe and critically ill patients, with the potential to collaborate on additional COVID-19 studies. The NIH of Mexico is an organization that coordinates the main institutions of medical care.
The study will consist of only 25 patients and the company believes that it could receive the approval very quickly in Mexico as the anecdotal data received by CytoDyn (from more than70 COVID-19 critical patients who were treated under EIND in the United States) impressed the NIH of Mexico.
Per the MOU, CytoDyn will supply leronlimab at its expense to the NIH and both parties willproceed expeditiously to complete the mutually-agreed protocol for this study.
Shares of the company have soared 777% year to date against the industry’s decline of 7.2%.
Leronlimab is an investigational, humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases, including NASH. The FDA has granted a Fast Track designation to leronlimab for two potential indications of deadly diseases —one as a combination therapy with HAART for HIV-infected patients and another for metastatic triple-negative breast cancer.
At this time, there are minimal treatment options for COVID-19. A potential approval of leronlimab will be a huge breakthrough to meet this unmet medical need.
The company filed its biologics license application (BLA) with the FDA for leronlimab as a combination therapy for highly treatment-experienced HIV patients on Apr 27, 2020, and submitted additional FDA requested clinical datasets on May 11.
Zacks Rank & Stocks to Consider
CytoDyn currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the medical drugs sector are Amneal Pharmaceuticals Inc. (AMRX - Free Report) , Ono Pharmaceutical Co. (OPHLF - Free Report) and BioLineRx Ltd. (BLRX - Free Report) , all carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amneal’s earnings per share estimates have increased from 49 cents to 57 cents for 2020 and from 63 cents to 68 cents for 2021 in the past 60 days.
Ono Pharmaceutical’s earnings per share estimates have increased from $1.14 to $1.20 for 2020 and from $1.24 to $1.27 for 2021 in the past 60 days.
BioLineRx’s loss per share estimates have narrowed from $2.77 to $2.24 for 2020 and from $3.01 to $2.88 for 2021in the past 60 days.
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