Investors will focus on pipeline updates when
CytoDyn Inc. ( CYDY Quick Quote CYDY - Free Report) reports fourth-quarter 2020 results.
CytoDyn’s stock has surged 382% in the year so far against the
industry's decline of 6.5%.
The company missed earnings estimates in the last reported quarter by 45.84%.
Let us see how things have shaped up prior to this announcement.
Factors to Note
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel, humanized, monoclonal antibody targeting the CCR5 receptor. Hence, investors will primarily focus on pipeline updates on the same.
CytoDyn has successfully completed a phase III study on leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
Last month, the company received a Refusal to File letter from the FDA regarding its Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients. The FDA has informed CytoDyn that its BLA does not contain certain information needed to complete a substantive review and therefore, the FDA will not accept the BLA at this time.
CytoDyn intends to request a Type A meeting with the FDA to discuss its request for additional information. Nevertheless, the agency does not require any additional clinical trials to be conducted, while the company will conduct additional analysis of completed trials.
CytoDyn recently announced results of the patient safety data from its COVID-19 phase II study for mild-to-moderate indications. This trial was designed to evaluate the safety and efficacy of leronlimab and the results of the efficacy portion of the data are anticipated to be released as soon as the statistical analyses of all primary and secondary endpoints are completed.
CytoDyn has also initiated a phase II study to evaluate leronlimab for the treatment of non-alcoholic steatohepatitis (NASH). The study will test whether leronlimab can control the liver fibrosis associated with NASH.
Operating expenses are expected to have increase from the previous quarter due to multiple ongoing studies.
Our proven model does not conclusively predict an earnings beat for CytoDyn this time around. The combination of a positive
Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. Unfortunately, that is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Earnings ESP: Earnings ESP for CytoDyn is 0.00%.
Zacks Rank: The company currently carries a Zacks Rank #3.
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