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CytoDyn Requests Covid-19 Emergency Use Approval For Leronlimab
Corona

CytoDyn Requests Covid-19 Emergency Use Approval For Leronlimab

Late-stage biotech CytoDyn Inc (CYDY) has announced that it has provided its Top-line Report from its recently completed Phase 2 trial of leronlimab for COVID-19 patients with mild-to-moderate symptoms to the U.S. Food and Drug Administration (FDA), and requested emergency use approval.

In addition, CytoDyn has sent its report to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines.

At the same time, the company revealed that it has also been approached by several doctors about a clinical study of leronlimab in long-hauler COVID-19 individuals. CytoDyn is now preparing a Phase 3 protocol and will file it as soon as possible.

Nader Pourhassan, CEO of CytoDyn, stated, “We believe the statistically significant data of NEWS2 findings, along with impressive safety results, from our Phase 2 trial set forth in the Top-line Report provides compelling data in support of leronlimab’s use to fight COVID-19… We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations, mild-to-moderate, severe-to-critical, and long-haulers.”     

Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

So far the FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control.

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. (See CytoDyn stock analysis on TipRanks).

Shares in CYDY are currently trading up a whopping 276% year-to-date- however analyst Yi Chen of HC Wainwright is staying sidelined on the stock for now. He reiterated his hold rating after CytoDyn reported the positive Phase 2 trial results. “These results show that leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is safe and can deliver rapid improvement in symptoms associated with the coronavirus infection, in our view” Chen commented on August 17.

The analyst told investors: “In anticipation of both additional clinical data and agency feedback, we reiterate our Neutral rating without a price target.” Chen cited market valuation and volatility as the reasons for removing his prior $4 price target.

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