It has been a busy week for the biotech sector with third-quarter earnings releases and regulatory and pipeline updates. The development of coronavirus vaccines and treatments and subsequent progress also continue to be in the spotlight.
Recap of the Week’s Most Important Stories:
Regeneron Q3 Earnings, Other Updates: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) posted better-than-expected third-quarter 2021 results, beating on both earnings and sales driven by strong growth in lead ophthalmology drug Eylea and asthma drug Dupixent. Contribution from its antibody cocktail for COVID-19, REGEN-COV, also boosted the top line.
Regeneron announced additional positive results from a phase III study on REGEN-COV. The late-stage study assessed the use of a single dose of investigational REGEN-COV (1,200 mg administered via four subcutaneous injections) to prevent COVID-19 in uninfected individuals. The study is being jointly conducted with the National Institute of Allergy and Infectious Diseases.
The new analyses showed REGEN-COV reduced the risk of contracting COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.6% during the pre-specified follow-up period (months two to eight), maintaining the 81.4% risk reduction during the first month after administration. During the eight-month assessment period, no individuals in the REGEN-COV group were hospitalized due to COVID-19 compared to six individuals in the placebo group (one person in the first month; five people during months two to eight). There were no deaths due to COVID-19 in any treatment group during the eight-month assessment period, and there were no new safety signals identified for REGEN-COV.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Moderna’s Q3 Earnings, Vaccine Updates: Moderna (MRNA - Free Report) missed on both earnings and sales in the third quarter. Nevertheless, revenues were up year over year driven by the sales of its coronavirus vaccine, which is now approved for temporary/emergency use in several countries. Moreover, grants from an agreement with Biomedical Advanced Research and Development Authority related to the development of the COVID-19 vaccine drove revenues.
Moderna also announced that it has submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency for the evaluation of a 50 µg two-dose series of mRNA-12731 in children aged six to 11 years. The phase II “KidCOVE” study of mRNA-1273 in the pediatric population aged six months to under 12 years is ongoing. The FDA has granted priority review to its biologics license application seeking approval for its COVID-19 vaccine, mRNA-1273. A decision is expected in April 2022.
Cassava Surges on Review Data: Shares of Cassava Sciences, Inc. (SAVA - Free Report) surged after the Journal of Neuroscience reported that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease (AD). The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava and is foundational to simufilam, its candidate for the proposed treatment of AD. Simufilam is the company’s lead drug candidate, which is being evaluated for the treatment of AD. Cassava has also been embroiled in a few controversies. In August, there was a petition requesting the FDA to halt the current clinical studies of simufilam PTI-125 sponsored by Cassava questioning the integrity of the studies on various grounds.
Biohaven Plunges on Pfizer Deal: Shares of Biohaven Pharmaceutical Holding Company Ltd. (BHVN - Free Report) were down after the company announced a deal with pharma giant Pfizer (PFE - Free Report) for its migraine drug. Both the companies announced a strategic commercialization agreement for rimegepant in markets outside of the United States upon approval. Rimegepant is commercialized as Nurtec ODT in the United States for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine in adults.
Per the deal, Biohaven would continue to be primarily responsible for further clinical development of rimegepant and the parties will cooperate in regulatory activities to secure approval for the product. Biohaven will continue to solely commercialize Nurtec ODT in the United States and Pfizer would commercialize rimegepant, upon approval, in all regions outside the United States. Additionally, per the arrangement, Pfizer gains rights outside of the United States for zavegepant, a third-generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, currently being studied in an intranasal delivery and a soft-gel formulation in phase III studies for migraine indications.
Pfizer will make an upfront payment of $500 million, consisting of $150 million cash and $350 million in the purchase of Biohaven equity at a 25% market premium. The latter is also eligible to receive up to $740 million of milestone payments along with tiered double-digit royalties.
Performance
The Nasdaq Biotechnology Index has lost 3.70% in the past five trading sessions. Among the biotech giants, Moderna has lost 32.06% during the period. Over the past six months, shares of Moderna have soared 49.39%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY’s Q3 Earnings Beat, MRNA’s Vaccine Updates & More).
What's Next in Biotech?
Stay tuned for more earnings, pipeline, and regulatory updates.
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It has been a busy week for the biotech sector with third-quarter earnings releases and regulatory and pipeline updates. The development of coronavirus vaccines and treatments and subsequent progress also continue to be in the spotlight.
Recap of the Week’s Most Important Stories:
Regeneron Q3 Earnings, Other Updates: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) posted better-than-expected third-quarter 2021 results, beating on both earnings and sales driven by strong growth in lead ophthalmology drug Eylea and asthma drug Dupixent. Contribution from its antibody cocktail for COVID-19, REGEN-COV, also boosted the top line.
Regeneron announced additional positive results from a phase III study on REGEN-COV. The late-stage study assessed the use of a single dose of investigational REGEN-COV (1,200 mg administered via four subcutaneous injections) to prevent COVID-19 in uninfected individuals. The study is being jointly conducted with the National Institute of Allergy and Infectious Diseases.
The new analyses showed REGEN-COV reduced the risk of contracting COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.6% during the pre-specified follow-up period (months two to eight), maintaining the 81.4% risk reduction during the first month after administration. During the eight-month assessment period, no individuals in the REGEN-COV group were hospitalized due to COVID-19 compared to six individuals in the placebo group (one person in the first month; five people during months two to eight). There were no deaths due to COVID-19 in any treatment group during the eight-month assessment period, and there were no new safety signals identified for REGEN-COV.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Moderna’s Q3 Earnings, Vaccine Updates: Moderna (MRNA - Free Report) missed on both earnings and sales in the third quarter. Nevertheless, revenues were up year over year driven by the sales of its coronavirus vaccine, which is now approved for temporary/emergency use in several countries. Moreover, grants from an agreement with Biomedical Advanced Research and Development Authority related to the development of the COVID-19 vaccine drove revenues.
Moderna also announced that it has submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency for the evaluation of a 50 µg two-dose series of mRNA-12731 in children aged six to 11 years. The phase II “KidCOVE” study of mRNA-1273 in the pediatric population aged six months to under 12 years is ongoing. The FDA has granted priority review to its biologics license application seeking approval for its COVID-19 vaccine, mRNA-1273. A decision is expected in April 2022.
Cassava Surges on Review Data: Shares of Cassava Sciences, Inc. (SAVA - Free Report) surged after the Journal of Neuroscience reported that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease (AD). The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava and is foundational to simufilam, its candidate for the proposed treatment of AD. Simufilam is the company’s lead drug candidate, which is being evaluated for the treatment of AD. Cassava has also been embroiled in a few controversies. In August, there was a petition requesting the FDA to halt the current clinical studies of simufilam PTI-125 sponsored by Cassava questioning the integrity of the studies on various grounds.
Biohaven Plunges on Pfizer Deal: Shares of Biohaven Pharmaceutical Holding Company Ltd. (BHVN - Free Report) were down after the company announced a deal with pharma giant Pfizer (PFE - Free Report) for its migraine drug. Both the companies announced a strategic commercialization agreement for rimegepant in markets outside of the United States upon approval. Rimegepant is commercialized as Nurtec ODT in the United States for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine in adults.
Per the deal, Biohaven would continue to be primarily responsible for further clinical development of rimegepant and the parties will cooperate in regulatory activities to secure approval for the product. Biohaven will continue to solely commercialize Nurtec ODT in the United States and Pfizer would commercialize rimegepant, upon approval, in all regions outside the United States. Additionally, per the arrangement, Pfizer gains rights outside of the United States for zavegepant, a third-generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, currently being studied in an intranasal delivery and a soft-gel formulation in phase III studies for migraine indications.
Pfizer will make an upfront payment of $500 million, consisting of $150 million cash and $350 million in the purchase of Biohaven equity at a 25% market premium. The latter is also eligible to receive up to $740 million of milestone payments along with tiered double-digit royalties.
Performance
The Nasdaq Biotechnology Index has lost 3.70% in the past five trading sessions. Among the biotech giants, Moderna has lost 32.06% during the period. Over the past six months, shares of Moderna have soared 49.39%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY’s Q3 Earnings Beat, MRNA’s Vaccine Updates & More).
What's Next in Biotech?
Stay tuned for more earnings, pipeline, and regulatory updates.
Only $1 to See All Zacks' Buys and Sells
We're not kidding.
Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.
Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that closed 228 positions with double- and triple-digit gains in 2023 alone.
See Stocks Now >>
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