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The Zacks Analyst Blog Highlights Moderna, Gilead Sciences, Kodiak Sciences and Lexicon Pharmaceuticals
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For Immediate Release
Chicago, IL – March 4, 2022 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Moderna (MRNA - Free Report) , Gilead Sciences, Inc. (GILD - Free Report) , Kodiak Sciences Inc. (KOD - Free Report) and Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) .
Here are highlights from Thursday’s Analyst Blog:
Biotech Stock Roundup: MRNA, KOD, LXRX and More
Earnings results and other regulatory updates have grabbed focus in the biotech sector this week.
Recap of the Week's Most Important Stories:
Moderna's Q4 Results: Moderna beat on earnings and sales in the fourth quarter. The company reported earnings of $11.29 per share, which easily beat the Zacks Consensus Estimate of $9.83. The company had incurred a loss of 69 cents per share in the year-ago quarter. The significant improvement in the bottom line was driven by strong year-over-year growth in revenues.
Revenues in the quarter were $7.2 billion, beating the Zacks Consensus Estimate of $6.71 billion. In the year-ago quarter, revenues were $571 million. The significant increase in the top line was driven by the strong sales of its coronavirus vaccine, which is now approved or authorized for temporary/emergency use in several countries.
Moderna has several advance purchase agreements for its COVID-19 vaccine with multiple countries for 2022, worth $19 billion. These agreements also include an option for the delivery of potential updated COVID-19 vaccine booster candidates aggregating $3 billion.
Gilead Receives CRL for Lenacapavir: Gilead Sciences, Inc. announced that the FDA has issued a complete response letter (CRL) for the new drug application (NDA) for lenacapavir. The candidate is an investigational, long-acting HIV-1 capsid inhibitor under review for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.
The FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial as the reason for their action. The regulatory body has raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution, which has resulted in a clinical hold for injectable lenacapavir.
Kodiak Plunges on Study Results: Shares of Kodiak Sciences Inc. plummeted after the company announced dismal top-line results from its phase IIb/III study on KSI-301, a novel antibody biopolymer conjugate, in treatment-naïve subjects with neovascular (wet) age-related macular degeneration. The randomized, double-masked, active comparator-controlled study is evaluating the efficacy, durability and safety of KSI-301, a novel antibody biopolymer conjugate, in treatment-naïve subjects with neovascular (wet) age-related macular degeneration.
The results of the study showed that although KSI-301 demonstrated strong durability and was safe and well-tolerated, it did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains for subjects dosed on extended regimens compared to aflibercept given every eight weeks. Investors were clearly disappointed as KSI-301is the lead candidate for Kodiak.
Lexicon Down on Regulatory Update: Shares of Lexicon Pharmaceuticals, Inc. plunged after the company announced that it is voluntarily withdrawing its NDA for sotagliflozin. Lexicon had submitted an NDA to the FDA at the end of the fourth quarter of 2021 seeking approval for the marketing and sale of sotagliflozin, to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction.
The NDA was withdrawn to correct a technical issue with the submission recently identified by the company. Nevertheless, Lexicon plans to resubmit it in the second quarter of 2022.
7 Best Stocks for the Next 30 Days
Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."
Since 1988, the full list has beaten the market more than 2X over with an average gain of +25.4% per year. So be sure to give these hand-picked 7 your immediate attention.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights Moderna, Gilead Sciences, Kodiak Sciences and Lexicon Pharmaceuticals
For Immediate Release
Chicago, IL – March 4, 2022 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Moderna (MRNA - Free Report) , Gilead Sciences, Inc. (GILD - Free Report) , Kodiak Sciences Inc. (KOD - Free Report) and Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) .
Here are highlights from Thursday’s Analyst Blog:
Biotech Stock Roundup: MRNA, KOD, LXRX and More
Earnings results and other regulatory updates have grabbed focus in the biotech sector this week.
Recap of the Week's Most Important Stories:
Moderna's Q4 Results: Moderna beat on earnings and sales in the fourth quarter. The company reported earnings of $11.29 per share, which easily beat the Zacks Consensus Estimate of $9.83. The company had incurred a loss of 69 cents per share in the year-ago quarter. The significant improvement in the bottom line was driven by strong year-over-year growth in revenues.
Revenues in the quarter were $7.2 billion, beating the Zacks Consensus Estimate of $6.71 billion. In the year-ago quarter, revenues were $571 million. The significant increase in the top line was driven by the strong sales of its coronavirus vaccine, which is now approved or authorized for temporary/emergency use in several countries.
Moderna has several advance purchase agreements for its COVID-19 vaccine with multiple countries for 2022, worth $19 billion. These agreements also include an option for the delivery of potential updated COVID-19 vaccine booster candidates aggregating $3 billion.
Moderna carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Gilead Receives CRL for Lenacapavir: Gilead Sciences, Inc. announced that the FDA has issued a complete response letter (CRL) for the new drug application (NDA) for lenacapavir. The candidate is an investigational, long-acting HIV-1 capsid inhibitor under review for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.
The FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial as the reason for their action. The regulatory body has raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution, which has resulted in a clinical hold for injectable lenacapavir.
Kodiak Plunges on Study Results: Shares of Kodiak Sciences Inc. plummeted after the company announced dismal top-line results from its phase IIb/III study on KSI-301, a novel antibody biopolymer conjugate, in treatment-naïve subjects with neovascular (wet) age-related macular degeneration. The randomized, double-masked, active comparator-controlled study is evaluating the efficacy, durability and safety of KSI-301, a novel antibody biopolymer conjugate, in treatment-naïve subjects with neovascular (wet) age-related macular degeneration.
The results of the study showed that although KSI-301 demonstrated strong durability and was safe and well-tolerated, it did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains for subjects dosed on extended regimens compared to aflibercept given every eight weeks. Investors were clearly disappointed as KSI-301is the lead candidate for Kodiak.
Lexicon Down on Regulatory Update: Shares of Lexicon Pharmaceuticals, Inc. plunged after the company announced that it is voluntarily withdrawing its NDA for sotagliflozin. Lexicon had submitted an NDA to the FDA at the end of the fourth quarter of 2021 seeking approval for the marketing and sale of sotagliflozin, to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction.
The NDA was withdrawn to correct a technical issue with the submission recently identified by the company. Nevertheless, Lexicon plans to resubmit it in the second quarter of 2022.
7 Best Stocks for the Next 30 Days
Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."
Since 1988, the full list has beaten the market more than 2X over with an average gain of +25.4% per year. So be sure to give these hand-picked 7 your immediate attention.
See them now >>
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.