We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Biotech Stock Roundup: Coronavirus Updates From REGN, MRNA, & Other Updates
Read MoreHide Full Article
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:
Regeneron Reports Positive Data for Antibody Cocktail: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced positive initial results from an ongoing phase III study evaluating its antibody cocktail, REGEN-COV (casirivimab and imdevimab antibody cocktail). The cocktail, which was granted an Emergency Use Authorization (EUA) by the FDA last year, was used as a passive vaccine for the prevention of COVID-19 in people who are at high risk of infection (due to household exposure to a COVID-19 patient). The data suggest that REGEN-COV as a passive vaccine may both reduce transmission of the virus as well as the viral and disease burden in those who still get infected.
An exploratory analysis was conducted on the first approximately 400 evaluable individuals enrolled in the trial, who were randomized to receive passive vaccination with REGEN-COV (1,200 mg via subcutaneous injections) or placebo. The results showed that passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic infection and approximately 50% lower overall rate of infection (symptomatic and asymptomatic). The lower number of infections occurring with the REGEN-COV therapy was all asymptomatic, with decreased peak virus levels and short duration of viral shedding. Infections in the REGEN-COV group lasted not more than one week, while approximately 40% of infections in the placebo group lasted three to four weeks. No infected individuals in the REGEN-COV group had high viral loads.
Exelixis Wins FDA Nod for Cabometyx Combo: Exelixis, Inc. (EXEL - Free Report) announced that the FDA approved lead drug, Cabometyx, in combination with Bristol-Myers Squibb Company (BMY - Free Report) ’s immuno-oncology drug, Opdivo, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval came ahead of the Prescription Drug User Fee Act (PDUFA) action date of Feb 20, 2021. The FDA approval was based on positive results of the CheckMate -9ER study, wherein the combination of Cabometyx and Opdivo significantly improved overall survival while doubling progression-free survival and objective response rate compared to Sutent as a first-line treatment for patients with advanced RCC, one of the most common forms of kidney cancer.
Moderna Up on Update on Its COVID-19 Vaccine: Shares of Moderna, Inc. (MRNA - Free Report) gained after it announced a supply update on its COVID-19 vaccine. Per the company, 30.4 million doses have been supplied to the U.S. government to date. The company confirmed that it is on track to deliver on its commitment of providing approximately 100 million doses to the U.S. government by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter.
Earlier, the company announced that its vaccine provides protection against new emerging strains of the virus as well. Results from in vitro neutralization studies of sera from individuals vaccinated with COVID-19 Vaccine showed activity against emerging strains of SARS-CoV-2 and vaccination with the COVID-19 vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the U.K. and the Republic of South Africa, respectively.
Aurinia Gains on Drug Approval: Shares of Aurinia Pharmaceuticals Inc. (AUPH - Free Report) rallied after it announced an FDA approval of its new drug application (“NDA”) for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (“LN”), a kidney disorder. The approval was based on promising data from pivotal studies evaluating the drug in combination with standard-of-care (SoC). Data showed that patients receiving Lupkynis in addition to SoC were more than twice as likely to achieve renal response compared to SoC alone. Moreover, the Lupkynis combo also reduced urine protein creatinine ratio twice as fast as SoC alone.
Vertex sNDA for Trikafta Accepted by FDA: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for the approved indication of Trikafta to include children aged 6 years through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data. The agency has granted Priority Review to the sNDA and assigned a PDUFA target action date of Jun 8, 2021.
The Nasdaq Biotechnology Index inched up 0.01% in the last five trading sessions. Among the biotech giants, Incyte gained 5.78% during this period. Over the past six months, shares of Alexion have rallied 51.38%. (See the last biotech stock roundup here: Biotech Stock Roundup: ALXN Pauses Study, ACRS & GRTS Surge, & Other Updates)
What's Next in Biotech?
Stay tuned for more pipeline, regulatory and upcoming earnings updates.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
These 7 were selected because of their superior potential for immediate breakout.
Image: Bigstock
Biotech Stock Roundup: Coronavirus Updates From REGN, MRNA, & Other Updates
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:
Regeneron Reports Positive Data for Antibody Cocktail: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced positive initial results from an ongoing phase III study evaluating its antibody cocktail, REGEN-COV (casirivimab and imdevimab antibody cocktail). The cocktail, which was granted an Emergency Use Authorization (EUA) by the FDA last year, was used as a passive vaccine for the prevention of COVID-19 in people who are at high risk of infection (due to household exposure to a COVID-19 patient). The data suggest that REGEN-COV as a passive vaccine may both reduce transmission of the virus as well as the viral and disease burden in those who still get infected.
An exploratory analysis was conducted on the first approximately 400 evaluable individuals enrolled in the trial, who were randomized to receive passive vaccination with REGEN-COV (1,200 mg via subcutaneous injections) or placebo. The results showed that passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic infection and approximately 50% lower overall rate of infection (symptomatic and asymptomatic). The lower number of infections occurring with the REGEN-COV therapy was all asymptomatic, with decreased peak virus levels and short duration of viral shedding. Infections in the REGEN-COV group lasted not more than one week, while approximately 40% of infections in the placebo group lasted three to four weeks. No infected individuals in the REGEN-COV group had high viral loads.
Exelixis Wins FDA Nod for Cabometyx Combo: Exelixis, Inc. (EXEL - Free Report) announced that the FDA approved lead drug, Cabometyx, in combination with Bristol-Myers Squibb Company (BMY - Free Report) ’s immuno-oncology drug, Opdivo, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval came ahead of the Prescription Drug User Fee Act (PDUFA) action date of Feb 20, 2021. The FDA approval was based on positive results of the CheckMate -9ER study, wherein the combination of Cabometyx and Opdivo significantly improved overall survival while doubling progression-free survival and objective response rate compared to Sutent as a first-line treatment for patients with advanced RCC, one of the most common forms of kidney cancer.
Moderna Up on Update on Its COVID-19 Vaccine: Shares of Moderna, Inc. (MRNA - Free Report) gained after it announced a supply update on its COVID-19 vaccine. Per the company, 30.4 million doses have been supplied to the U.S. government to date. The company confirmed that it is on track to deliver on its commitment of providing approximately 100 million doses to the U.S. government by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter.
Earlier, the company announced that its vaccine provides protection against new emerging strains of the virus as well. Results from in vitro neutralization studies of sera from individuals vaccinated with COVID-19 Vaccine showed activity against emerging strains of SARS-CoV-2 and vaccination with the COVID-19 vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the U.K. and the Republic of South Africa, respectively.
Aurinia Gains on Drug Approval: Shares of Aurinia Pharmaceuticals Inc. (AUPH - Free Report) rallied after it announced an FDA approval of its new drug application (“NDA”) for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (“LN”), a kidney disorder. The approval was based on promising data from pivotal studies evaluating the drug in combination with standard-of-care (SoC). Data showed that patients receiving Lupkynis in addition to SoC were more than twice as likely to achieve renal response compared to SoC alone. Moreover, the Lupkynis combo also reduced urine protein creatinine ratio twice as fast as SoC alone.
Vertex sNDA for Trikafta Accepted by FDA: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for the approved indication of Trikafta to include children aged 6 years through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data. The agency has granted Priority Review to the sNDA and assigned a PDUFA target action date of Jun 8, 2021.
Vertex currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index inched up 0.01% in the last five trading sessions. Among the biotech giants, Incyte gained 5.78% during this period. Over the past six months, shares of Alexion have rallied 51.38%. (See the last biotech stock roundup here: Biotech Stock Roundup: ALXN Pauses Study, ACRS & GRTS Surge, & Other Updates)
What's Next in Biotech?
Stay tuned for more pipeline, regulatory and upcoming earnings updates.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>