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Biotech Stock Roundup: REGN Cocktail Data Positive, INCY's Jakafi Disappoints & More
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The biotech sector continues to be in focus with updates on the development of antibodies and vaccines for coronavirus. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Regeneron Reports Positive Data on COVID-19 Cocktail: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that its phase III outcomes trial on REGEN-COV (casirivimab with imdevimab) in high-risk non-hospitalized COVID-19 patients was successful.
The study, evaluating its investigational cocktail antibody REGEN-COV in infected non-hospitalized patients (n=4,567), met its primary endpoint. The study showed that REGEN-COV significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo. REGEN-COV also met all secondary endpoints in the phase III outcomes trial, including the ability to reduce symptom duration.
Additionally, a companion phase II study showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first seven study days comparable to the 2,400 mg and 1,200 mg IV doses.
Ionis Plunges on Study Update: Shares of Ionis Pharmaceuticals, Inc. (IONS - Free Report) plummeted after it announced that its partner Roche (RHHBY - Free Report) stopped dosing in the late-stage GENERATION HD1 study of tominersen in manifest Huntington's disease (HD). The decision was based on the results of a pre-planned review of data from the phase III study conducted by an unblinded independent Data Monitoring Committee (iDMC).
The iDMC recommendation was based on the potential benefit/risk profile of study participants. Nevertheless, no new or emerging safety signals identified for tominersen. Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen. Roche licensed the investigational molecule from Ionis in 2017.
Incyte’s Jakafi Fails in ARDS Study: Incyte (INCY - Free Report) announced that the phase III DEVENT study on Jakafi in patients on mechanical ventilation with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) was not successful. The study evaluated the efficacy and safety of Jakafi (5mg and 15mg) plus standard of care (SoC) versus SoC alone in these patients.
The DEVENT study did not meet its primary endpoint — mortality due to any cause through day 29 — adjusted for ARDS severity between the two treatment arms versus placebo. The results however indicate a trend toward an improvement in mortality in the overall study population.
CureVac Expands COVID-19 Vaccine Candidate Study: CureVac N.V. (CVAC - Free Report) announced plans to expand and further specify the protocols of its ongoing late-stage clinical studies on CVnCoV, its COVID-19 vaccine candidate. The efficacy of the mRNA-based candidate is currently being evaluated in the pivotal HERALD phase IIb/3 study in Europe and Latin America. This will allow determining the efficacy of the vaccine candidate for select variants.
The company is in discussions with the European Medicines Agency (EMA) to potentially include an amendment related to select virus strains in the study. The progress in the phase IIa trial in older adults in Peru and Panama enables the addition of a secondary vaccine efficacy endpoint.
The recent publication of preclinical data demonstrated that CVnCoV protects against various emerging infections with the SARS-CoV-2 Variant of Concern B.1.351 (the "South African" variant) and a strain of the original SARS-CoV-2 B1 lineage (BavPat1) in a transgenic mouse model.
Zealand’s Drug Wins FDA Approval: Zealand Pharma announced that the FDA has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes, aged 6 years and above. The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter phase III studies of Zegalogue in children aged 6 to 17 and adults with type 1 diabetes.
The primary efficacy endpoint for all three studies was time to plasma glucose recovery (treatment success). The primary endpoint was successfully achieved across the adult and pediatric studies, with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes for placebo.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Stay tuned for more pipeline and regulatory updates.
Time to Invest in Legal Marijuana
If you’re looking for big gains, there couldn’t be a better time to get in on a young industry primed to skyrocket from $17.7 billion back in 2019 to an expected $73.6 billion by 2027.
After a clean sweep of 6 election referendums in 5 states, pot is now legal in 36 states plus D.C. Federal legalization is expected soon and that could be a still greater bonanza for investors. Even before the latest wave of legalization, Zacks Investment Research has recommended pot stocks that have shot up as high as +285.9%
You’re invited to check out Zacks’ Marijuana Moneymakers: An Investor’s Guide. It features a timely Watch List of pot stocks and ETFs with exceptional growth potential.
Image: Bigstock
Biotech Stock Roundup: REGN Cocktail Data Positive, INCY's Jakafi Disappoints & More
The biotech sector continues to be in focus with updates on the development of antibodies and vaccines for coronavirus. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Regeneron Reports Positive Data on COVID-19 Cocktail: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that its phase III outcomes trial on REGEN-COV (casirivimab with imdevimab) in high-risk non-hospitalized COVID-19 patients was successful.
The study, evaluating its investigational cocktail antibody REGEN-COV in infected non-hospitalized patients (n=4,567), met its primary endpoint. The study showed that REGEN-COV significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo. REGEN-COV also met all secondary endpoints in the phase III outcomes trial, including the ability to reduce symptom duration.
Additionally, a companion phase II study showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first seven study days comparable to the 2,400 mg and 1,200 mg IV doses.
Ionis Plunges on Study Update: Shares of Ionis Pharmaceuticals, Inc. (IONS - Free Report) plummeted after it announced that its partner Roche (RHHBY - Free Report) stopped dosing in the late-stage GENERATION HD1 study of tominersen in manifest Huntington's disease (HD). The decision was based on the results of a pre-planned review of data from the phase III study conducted by an unblinded independent Data Monitoring Committee (iDMC).
The iDMC recommendation was based on the potential benefit/risk profile of study participants. Nevertheless, no new or emerging safety signals identified for tominersen. Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen. Roche licensed the investigational molecule from Ionis in 2017.
Incyte’s Jakafi Fails in ARDS Study: Incyte (INCY - Free Report) announced that the phase III DEVENT study on Jakafi in patients on mechanical ventilation with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) was not successful. The study evaluated the efficacy and safety of Jakafi (5mg and 15mg) plus standard of care (SoC) versus SoC alone in these patients.
The DEVENT study did not meet its primary endpoint — mortality due to any cause through day 29 — adjusted for ARDS severity between the two treatment arms versus placebo. The results however indicate a trend toward an improvement in mortality in the overall study population.
CureVac Expands COVID-19 Vaccine Candidate Study: CureVac N.V. (CVAC - Free Report) announced plans to expand and further specify the protocols of its ongoing late-stage clinical studies on CVnCoV, its COVID-19 vaccine candidate. The efficacy of the mRNA-based candidate is currently being evaluated in the pivotal HERALD phase IIb/3 study in Europe and Latin America. This will allow determining the efficacy of the vaccine candidate for select variants.
The company is in discussions with the European Medicines Agency (EMA) to potentially include an amendment related to select virus strains in the study. The progress in the phase IIa trial in older adults in Peru and Panama enables the addition of a secondary vaccine efficacy endpoint.
The recent publication of preclinical data demonstrated that CVnCoV protects against various emerging infections with the SARS-CoV-2 Variant of Concern B.1.351 (the "South African" variant) and a strain of the original SARS-CoV-2 B1 lineage (BavPat1) in a transgenic mouse model.
Zealand’s Drug Wins FDA Approval: Zealand Pharma announced that the FDA has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes, aged 6 years and above. The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter phase III studies of Zegalogue in children aged 6 to 17 and adults with type 1 diabetes.
The primary efficacy endpoint for all three studies was time to plasma glucose recovery (treatment success). The primary endpoint was successfully achieved across the adult and pediatric studies, with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes for placebo.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 3.52% in the last five trading sessions. Among the biotech giants, Biogen gained 2.80% during the period. Over the past six months, shares of Alexion have surged 35.36%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN's Cancer Drug Positive, COVID-19 Updates From NVAX & More).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Time to Invest in Legal Marijuana
If you’re looking for big gains, there couldn’t be a better time to get in on a young industry primed to skyrocket from $17.7 billion back in 2019 to an expected $73.6 billion by 2027.
After a clean sweep of 6 election referendums in 5 states, pot is now legal in 36 states plus D.C. Federal legalization is expected soon and that could be a still greater bonanza for investors. Even before the latest wave of legalization, Zacks Investment Research has recommended pot stocks that have shot up as high as +285.9%
You’re invited to check out Zacks’ Marijuana Moneymakers: An Investor’s Guide. It features a timely Watch List of pot stocks and ETFs with exceptional growth potential.
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