Traders should take note of the fact that CytoDyn Inc (OTCMKTS:CYDY) just announced that it has filed with the U.S. Food and Drug Administration (FDA) a request seeking Priority Review designation for the Company’s Biologics License Application (BLA) for leronlimab as a combination therapy for HIV indication.
According to the release, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). FDA informs the applicant of a Priority Review designation within 60 days.
CytoDyn Inc (OTCMKTS:CYDY) promulgates itself as a late-stage biotechnology company that focuses on the clinical development and commercialization of humanized monoclonal antibodies to treat human immunodeficiency virus (HIV) infection.
Its lead product is PRO 140, a therapeutic anti-viral agent, which is in Phase IIb extension study for HIV as monotherapy, rollover study for HIV as a combination therapy, Phase IIb/III investigative trial for HIV, Phase Ib/II trial for triple-negative breast cancer, and Phase II trial for graft-versus-host disease.
CytoDyn Inc. has strategic agreement with Samsung BioLogics Co. Ltd. for the clinical and commercial manufacturing of leronlimab. The company was formerly known as RexRay Corporation. CytoDyn Inc. was incorporated in 2002 and is based in Vancouver, Washington.
According to company materials, “CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.”
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As noted above, CYDY just announced that it has filed with the U.S. Food and Drug Administration (FDA) a request seeking Priority Review designation for the Company’s Biologics License Application (BLA) for leronlimab as a combination therapy for HIV indication.
While this is a clear factor, it has been incorporated into a trading tape characterized by a pretty dominant offer, which hasn’t been the type of action CYDY shareholders really want to see. In total, over the past five days, shares of the stock have dropped by roughly -4% on above average trading volume. All in all, not a particularly friendly tape, but one that may ultimately present some new opportunities. Furthermore, the listing has witnessed a pop in interest, as transaction volume levels have recently pushed 2% over what the stock has registered over the longer term.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We look forward to the FDA’s decision on our important request and are hopeful that we can bring leronlimab therapy to highly treatment experienced HIV patients by late 2020. Leronlimab’s potential for many other indications could be expedited, should the Company receive its first approval. All other potential indications (and we believe there are many) could have a much faster approval process as label expansion approvals.”
Now commanding a market cap of $1.48B, CYDY has a significant war chest ($7.1M) of cash on the books, which stands against about $41M in total current liabilities. One should also note that debt has been growing over recent quarters. The company is pre-revenue at this point. This is an exciting story, and we look forward to a follow-up chapter as events transpire. Sign-up for continuing coverage on shares of $CYDY stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $CYDY, either long or short, and we have not been compensated for this article.