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The Zacks Analyst Blog Highlights: Gilead Sciences, Regeneron Pharma, Sanofi, Novavax and Translate Bio
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For Immediate Release
Chicago, IL – March 17, 2021 – 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: Gilead Sciences, Inc. (GILD - Free Report) , Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Sanofi (SNY - Free Report) , Novavax, Inc. (NVAX - Free Report) and Translate Bio, Inc. (TBIO - Free Report) .
Here are highlights from Tuesday’s Analyst Blog:
Biotech Stock Roundup: GILD, REGN, SNY and More
The biotech sector continues to be in focus as the development of antibodies and vaccines for coronavirus is gaining importance with each passing day, with the pandemic refusing to die out. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Gilead, Merck to Develop HIV Treatments: Gilead Sciences announced a collaboration agreement with pharma giant Merck to co-develop and co-commercialize long-acting treatments in HIV. The companies have collaborated to evaluate Gilead’s investigational capsid inhibitor, lenacapavir, with Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, to form a two-drug regimen for HIV patients.
Both candidates are currently in late-stage development and have demonstrated activity at low dosages in clinical studies. The first studies of the oral combination are expected to begin in the second half of 2021. Per the terms, Gilead and Merck will share operational responsibilities, as well as development, commercialization and marketing costs, and any future revenues.
Regeneron, Sanofi’s Libtayo Positive for Cervical Cancer: Regeneron Pharmaceuticals and partner Sanofi announced that the phase III study evaluating the PD-1 inhibitor Libtayo monotherapy compared to chemotherapy in patients previously treated with chemotherapy, whose cervical cancer is recurrent or metastatic, demonstrated an overall survival (OS) benefit. Patients in the study were randomized to receive Libtayo monotherapy (350 mg every 3 weeks) or an investigator's choice of commonly used chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine).
Notably, the subjects receiving Libtayo experienced a 31% reduced risk of death. Among these, patients with squamous cell carcinoma experienced a 27% reduced risk of death while adenocarcinoma patients experienced a 44% reduced risk of death.
Significantly, based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), the study will be stopped early and the data will form the basis of regulatory submissions later in the year. Libtayo is already approved for advanced cutaneous squamous cell carcinoma (CSCC), advanced non-small cell lung cancer (NSCLC) and basal cell carcinoma (BCC).
Novavax’s Vaccine Effective Against Original & Variant COVID-19 Strains: Novavax announced impressive data from a phase III trial in the United Kingdom of its vaccine candidate, NVX–CoV237, against COVID-19. Data showed a final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19.
The company also announced a complete analysis of its phase IIb study taking place in South Africa, with an efficacy of 55.4% among the HIV-negative trial participants in a region where the vast majority of strains are B1.351 escape variants. The vaccine candidate demonstrated 100% protection against severe disease, including all hospitalization and death in both studies. Both studies achieved their statistical success criteria.
Translate Bio Gains on Vaccine Update: Shares of Translate Biogained after the company and partner Sanofi Pasteur, the vaccines global business unit of Sanofi, announced the initiation of the phase I/II study on MRT5500, a COVID-19 vaccine candidate. The phase I/II study is a randomized, double-blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of MRT5500.
Approximately 415 healthy adults aged 18 years or older are expected to be enrolled in the trial across 13 investigational sites. The participants will receive one dose of MRT5500, or two doses 21 days apart. Three different dose levels will be investigated (15µg, 45µg or 135µg). Consequently, Translate Bio will receive a $25-million payment based on the achievement of this milestone. Interim results from this study are expected in the third quarter of 2021.
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: Gilead Sciences, Regeneron Pharma, Sanofi, Novavax and Translate Bio
For Immediate Release
Chicago, IL – March 17, 2021 – 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: Gilead Sciences, Inc. (GILD - Free Report) , Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Sanofi (SNY - Free Report) , Novavax, Inc. (NVAX - Free Report) and Translate Bio, Inc. (TBIO - Free Report) .
Here are highlights from Tuesday’s Analyst Blog:
Biotech Stock Roundup: GILD, REGN, SNY and More
The biotech sector continues to be in focus as the development of antibodies and vaccines for coronavirus is gaining importance with each passing day, with the pandemic refusing to die out. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Gilead, Merck to Develop HIV Treatments: Gilead Sciences announced a collaboration agreement with pharma giant Merck to co-develop and co-commercialize long-acting treatments in HIV. The companies have collaborated to evaluate Gilead’s investigational capsid inhibitor, lenacapavir, with Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, to form a two-drug regimen for HIV patients.
Both candidates are currently in late-stage development and have demonstrated activity at low dosages in clinical studies. The first studies of the oral combination are expected to begin in the second half of 2021. Per the terms, Gilead and Merck will share operational responsibilities, as well as development, commercialization and marketing costs, and any future revenues.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regeneron, Sanofi’s Libtayo Positive for Cervical Cancer: Regeneron Pharmaceuticals and partner Sanofi announced that the phase III study evaluating the PD-1 inhibitor Libtayo monotherapy compared to chemotherapy in patients previously treated with chemotherapy, whose cervical cancer is recurrent or metastatic, demonstrated an overall survival (OS) benefit. Patients in the study were randomized to receive Libtayo monotherapy (350 mg every 3 weeks) or an investigator's choice of commonly used chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine).
Notably, the subjects receiving Libtayo experienced a 31% reduced risk of death. Among these, patients with squamous cell carcinoma experienced a 27% reduced risk of death while adenocarcinoma patients experienced a 44% reduced risk of death.
Significantly, based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), the study will be stopped early and the data will form the basis of regulatory submissions later in the year. Libtayo is already approved for advanced cutaneous squamous cell carcinoma (CSCC), advanced non-small cell lung cancer (NSCLC) and basal cell carcinoma (BCC).
Novavax’s Vaccine Effective Against Original & Variant COVID-19 Strains: Novavax announced impressive data from a phase III trial in the United Kingdom of its vaccine candidate, NVX–CoV237, against COVID-19. Data showed a final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19.
The company also announced a complete analysis of its phase IIb study taking place in South Africa, with an efficacy of 55.4% among the HIV-negative trial participants in a region where the vast majority of strains are B1.351 escape variants. The vaccine candidate demonstrated 100% protection against severe disease, including all hospitalization and death in both studies. Both studies achieved their statistical success criteria.
Translate Bio Gains on Vaccine Update: Shares of Translate Bio gained after the company and partner Sanofi Pasteur, the vaccines global business unit of Sanofi, announced the initiation of the phase I/II study on MRT5500, a COVID-19 vaccine candidate. The phase I/II study is a randomized, double-blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of MRT5500.
Approximately 415 healthy adults aged 18 years or older are expected to be enrolled in the trial across 13 investigational sites. The participants will receive one dose of MRT5500, or two doses 21 days apart. Three different dose levels will be investigated (15µg, 45µg or 135µg). Consequently, Translate Bio will receive a $25-million payment based on the achievement of this milestone. Interim results from this study are expected in the third quarter of 2021.
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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.