CytoDyn Inc (OTCMKTS: CYDY) stock has posted impressive gains ever since the biotechnology company posted preclinical data showing its candidate drug Leronlimab as the potential to suppress breast cancer metastatic burden. The stock has since rallied by more than 10%, from all-time lows.
CYDY Catalysts And Share Price Analysis
While the stock remains engulfed in a long-term bear trend, after succumbing to bearish pressure in recent months, it has started showing signs of bottoming out. One of the triggers fuelling the upside action is the confirmation that the Food and Drug Administration has granted the Company a Fast Track Designation for Leronlimab.
The biotechnology company has also confirmed that it is expanding trials on Leronlimab as possible preventive care for Non-alcoholic Steatohepatitis (NASH) in humanized murine models. CytoDyn has also entered into an agreement with Samsung BioLogics for the manufacture of $1 billion worth of Leronlimab in a bid to meet expected demand for future revenues.
The stock has since started surging after hitting the floor in the aftermath of a ferocious sell-off. With the strengthening upward momentum showing signs of pushing the stock higher, immediate resistance standing in the way of further upside action is at the $0.56 mark.
A rally followed by a close above the $0.56 mark should bring to an end a sell-off that had plunged the stock to all-time lows. Above the $0.56 resistance mark, CytoDyn would stand a chance of making a run for the $0.68 mark, the next substantial resistance level.
Failure to take out the $0.56 level would leave the stock susceptible to further drops, as has been the case for the better part of the year.
What Does CytoDyn Do?
CytoDyn casts itself as a clinical stage biotechnology company engaged in the clinical development and commercialization of humanized monoclonal antibodies for the treatment of HIV infection. Its lead product is PRO 140 a novel humanized monoclonal antibody that targets the CCR5 receptor.
Shares of CytoDyn have started picking up some steam after a rollercoaster first quarter on the confirmation of the milestones achieved on the development of Leronlimab. The FDA has already granted a Fast Track Designation to the candidate drug for the treatment of patients with CCR5-positive metastatic triple negative breast cancer mTNBC.
“Currently, there are no enduring treatment options for mTNBC patients and, we thank the FDA for recognizing the potential of Leronlimab for mTNBC patients. We remain highly encouraged by the potential of Leronlimab (PRO 140) as a pipeline of opportunities within a single drug franchise,” stated Dr. Nader Pourhassan, Ph.D., President, CEO, and director.
In addition to being capable of suppressing metastatic cancer, Leronlimab has continued to show tremendous potential as a single agent for maintenance of HIV viral load suppression.
Leronlimab continues to show prospects when it comes to suppressing breast cancer metastatic burden by 98%. Buoyed by the trial results the Company is to expand the pre-clinical animal studies to eight other cancer indications. Plans are also underway to file an Orphan Drug designation with the FDA.
The positive clinical trial results come on the heels of CytoDyn inking a comprehensive strategic agreement with Samsung BioLogics Co for the clinical and commercial manufacturing of Leronlimab. The anticipated production has the potential to support revenues of approximately $1 billion.
“We are elated at the distinction of collaborating with the world’s preeminent biologics manufacturer for our franchise-defining drug. We are also currently evaluating several potential licensing deals for Leronlimab to commercialization companies. We are getting closer to have such agreements in place which will provide CytoDyn non-dilutive funds to execute on our vision,” stated Dr. Pourhassan.
CytoDyn has achieved significant progress on the development of its lead candidate drug Leronlimab for various indications. The fact that the drug has the potential to suppress HIV viral load, as well as breast cancer metastatic, affirms its credentials as a key driver of the share price on positive trial results going forward.
The stock bouncing off, all-time lows, in a recent trading session, could as well signal that it has reached a bottom and due for a correction higher. Underlying fundamentals should continue to strengthen investor confidence in the stock ideal for fuelling further upside action.
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Disclosure: We have no position in CYDY and have not been compensated for this article.