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CytoDyn (CYDY) to Report Q4 Earnings: What's in the Offing?
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Investors will focus on pipeline updates when CytoDyn Inc. (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.
Earnings Whispers
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.
Stocks to Consider
Here are a few stocks you may want to consider, as our model shows that these have the right combination of elements to post an earnings beat this season.
Incyte (INCY - Free Report) has an Earnings ESP of +4.62% and a Zacks Rank #3.
Pacira BioSciences, Inc. (PCRX - Free Report) has an Earnings ESP of +28.42% and a Zacks Rank of 2.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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CytoDyn (CYDY) to Report Q4 Earnings: What's in the Offing?
Investors will focus on pipeline updates when CytoDyn Inc. (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.
Earnings Whispers
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.
Stocks to Consider
Here are a few stocks you may want to consider, as our model shows that these have the right combination of elements to post an earnings beat this season.
Translate Bio (TBIO - Free Report) has an Earnings ESP of +7.69% and a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Incyte (INCY - Free Report) has an Earnings ESP of +4.62% and a Zacks Rank #3.
Pacira BioSciences, Inc. (PCRX - Free Report) has an Earnings ESP of +28.42% and a Zacks Rank of 2.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>