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Biotech Stock Roundup: ALXN to Raise Guidance, BMY to Buy MYOK & Other Updates
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It was a busy week for the biotech sector, with quite a few regulatory and other pipeline updates. While coronavirus-related news continues to grab headlines as President Trump tested positive, other regulatory events and pipeline news were also in the spotlight. Moreover, the sector was also in the spotlight on M&A activities.
Recap of the Week’s Most Important Stories:
Alexion Gains on Expected Increase in Outlook: Shares of Alexion Pharmaceuticals, Inc. gained after it announced that it plans to raise its annual guidance for 2020 by more than $200 million. An update on the same will be provided by the company when it releases third-quarter results. Moreover, the company expects to return at least $3 billion to shareholders through a multi-year stock buyback program, through 2023. Alexion also presented its strategic advancements at its Virtual Investor Day. The company highlighted its robust pipeline of more than 20 development programs across seven rare-disease franchises, with expected continued growth from more than five novel investigational new drug applications (INDs) by 2025. The company targets 2025 global revenues of $9-$10 billion and at least a 10% revenue compound annual growth rate (CAGR) through 2025 and beyond.
BioNTech Gains on COVID-19 Vaccine Progress: Shares of BioNTech (BNTX - Free Report) gained after it announced that it initiated a rolling submission to the European Medicines Agency (EMA) for lead pipeline candidate, BNT162b2, against COVID-19. The candidate is being developed in partnership with Pfizer, Inc. The rolling review was accepted by the EMA based on available preclinical and clinical data for BNT162b2 to date. The data suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. Both companies plan to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA).
Bristol-Myers to Buy MyoKardia: Bristol-Myers Squibb Company (BMY - Free Report) has entered into a definitive agreement with clinical-stage biopharmaceutical company, MyoKardia , in a bid to acquire the latter for $225 per share in cash or a total value of $13.1 billion. The deal is expected to close in the fourth quarter of 2020. The pending acquisition will strengthen Bristol Myers’ cardiovascular franchise as MyoKardia develops targeted therapies for the treatment of serious cardiovascular diseases. MyoKardia’s lead therapeutic candidate, mavacamten, a potential first-in-class cardiovascular medicine, is being developed for the treatment of obstructive hypertrophic cardiomyopathy (HCM). A new drug application for mavacamten for the same indication is expected to be filed in the first quarter of 2021 in the United States.
Earlier, Bristol-Myers announced that Opdivo (nivolumab) 360 mg every three weeks in combination with Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
Regeneron Gains on Experimental COVID-19 Therapy in Focus: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) gained after it confirmed the White House statement that it provided a single 8-gram dose of its experimental COVID-19 therapy, REGN-COV2, for the president. REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block the infectivity of SARS-CoV-2.
REGN-COV2 was provided in response to an Individual Patient Investigational New Drug (IND) application, which was commonly known as a “compassionate use” request from the President’s physicians. It is being evaluated for both treatment and prevention of COVID-19.
Reportedly, the president was also administered Gilead Sciences’ (GILD - Free Report) antiviral drug, remdesivir. The FDA had earlier granted Emergency Use Authorization (EUA) to remdesivir for the COVID-19 infection.
Corvus Surges on Positive COVID-19 Study Data: Shares of clinical-stage biopharmaceutical company, Corvus Pharmaceuticals, Inc. (CRVS - Free Report) , surged after it announced updated data from its ongoing phase I study evaluating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The updated data includes 56-day follow-up results from the first two cohorts (0.3 mg/kg and 1.0mg/kg dose) and initial results from the third cohort (3.0 mg/kg) of the study. Data showed a dose response with higher and more prolonged titers of anti-SARS-CoV-2 antibodies in the 1.0 mg/kg cohort compared to the 0.3 mg/kg cohort. The results further showed increased levels of memory B cells and memory T cells without any safety issues.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 1.86% in the last four trading sessions. Among the biotech giants, Alexion gained 1.44% during this period. Over the past six months, shares of Alexion have gained 33.03%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN's Cocktail Data, GILD's RA Drug Approval & Other Updates)
What's Next in Biotech?
Stay tuned for more pipeline updates.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Biotech Stock Roundup: ALXN to Raise Guidance, BMY to Buy MYOK & Other Updates
It was a busy week for the biotech sector, with quite a few regulatory and other pipeline updates. While coronavirus-related news continues to grab headlines as President Trump tested positive, other regulatory events and pipeline news were also in the spotlight. Moreover, the sector was also in the spotlight on M&A activities.
Recap of the Week’s Most Important Stories:
Alexion Gains on Expected Increase in Outlook: Shares of Alexion Pharmaceuticals, Inc. gained after it announced that it plans to raise its annual guidance for 2020 by more than $200 million. An update on the same will be provided by the company when it releases third-quarter results. Moreover, the company expects to return at least $3 billion to shareholders through a multi-year stock buyback program, through 2023. Alexion also presented its strategic advancements at its Virtual Investor Day. The company highlighted its robust pipeline of more than 20 development programs across seven rare-disease franchises, with expected continued growth from more than five novel investigational new drug applications (INDs) by 2025. The company targets 2025 global revenues of $9-$10 billion and at least a 10% revenue compound annual growth rate (CAGR) through 2025 and beyond.
Alexion currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BioNTech Gains on COVID-19 Vaccine Progress: Shares of BioNTech (BNTX - Free Report) gained after it announced that it initiated a rolling submission to the European Medicines Agency (EMA) for lead pipeline candidate, BNT162b2, against COVID-19. The candidate is being developed in partnership with Pfizer, Inc. The rolling review was accepted by the EMA based on available preclinical and clinical data for BNT162b2 to date. The data suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. Both companies plan to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA).
Bristol-Myers to Buy MyoKardia: Bristol-Myers Squibb Company (BMY - Free Report) has entered into a definitive agreement with clinical-stage biopharmaceutical company, MyoKardia , in a bid to acquire the latter for $225 per share in cash or a total value of $13.1 billion. The deal is expected to close in the fourth quarter of 2020. The pending acquisition will strengthen Bristol Myers’ cardiovascular franchise as MyoKardia develops targeted therapies for the treatment of serious cardiovascular diseases. MyoKardia’s lead therapeutic candidate, mavacamten, a potential first-in-class cardiovascular medicine, is being developed for the treatment of obstructive hypertrophic cardiomyopathy (HCM). A new drug application for mavacamten for the same indication is expected to be filed in the first quarter of 2021 in the United States.
Earlier, Bristol-Myers announced that Opdivo (nivolumab) 360 mg every three weeks in combination with Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
Regeneron Gains on Experimental COVID-19 Therapy in Focus: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) gained after it confirmed the White House statement that it provided a single 8-gram dose of its experimental COVID-19 therapy, REGN-COV2, for the president. REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block the infectivity of SARS-CoV-2.
REGN-COV2 was provided in response to an Individual Patient Investigational New Drug (IND) application, which was commonly known as a “compassionate use” request from the President’s physicians. It is being evaluated for both treatment and prevention of COVID-19.
Reportedly, the president was also administered Gilead Sciences’ (GILD - Free Report) antiviral drug, remdesivir. The FDA had earlier granted Emergency Use Authorization (EUA) to remdesivir for the COVID-19 infection.
Corvus Surges on Positive COVID-19 Study Data: Shares of clinical-stage biopharmaceutical company, Corvus Pharmaceuticals, Inc. (CRVS - Free Report) , surged after it announced updated data from its ongoing phase I study evaluating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The updated data includes 56-day follow-up results from the first two cohorts (0.3 mg/kg and 1.0mg/kg dose) and initial results from the third cohort (3.0 mg/kg) of the study. Data showed a dose response with higher and more prolonged titers of anti-SARS-CoV-2 antibodies in the 1.0 mg/kg cohort compared to the 0.3 mg/kg cohort. The results further showed increased levels of memory B cells and memory T cells without any safety issues.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 1.86% in the last four trading sessions. Among the biotech giants, Alexion gained 1.44% during this period. Over the past six months, shares of Alexion have gained 33.03%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN's Cocktail Data, GILD's RA Drug Approval & Other Updates)
What's Next in Biotech?
Stay tuned for more pipeline updates.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>