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Biotech Stock Roundup: Amgen Reports Q2, GILD's CAR T Therapy Gets Approval & More
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It was a busy week for the biotech sector with updates from most bigwigs. Amgen (AMGN - Free Report) reported better-than-expected second-quarter results. Apart from this, other regulatory and pipeline updates were in the spotlight.
Recap of the Week’s Most Important Stories:
Amgen Beats on Q2 Earnings and Sales: Amgen reported second-quarter 2020 earnings of $4.25 per share, which beat the Zacks Consensus Estimate of $3.81. Earnings rose 7% year over year. Total revenues of $6.21 billion in the quarter beat the Zacks Consensus Estimate of $6.18 billion. Higher sales of Otezla, Repatha and biosimilar products were offset by lower sales of other drugs including Prolia, Xgeva and Kyprolis due to COVID-19 and the erosion of mature brands from biosimilar/new competition. Amgen re-affirmed its previously issued sales guidance for 2020 while raising the earnings view range.
Gilead Gets FDA Approval for Tecartus: Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA granted accelerated approval to chimeric antigen receptor (CAR) T cell therapy, Tecartus, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval was based on results of ZUMA-2, a single-arm, open-label study, wherein 87% of patients responded to a single infusion of Tecartus, including 62% of patients achieving a complete response (CR). Among patients evaluable for safety, 18% experienced Grade 3 or higher cytokine release syndrome (CRS) and 37% experienced Grade 3 or higher neurologic toxicities.
Gilead and partner Galapagos NV (GLPG - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for its investigational, once-daily, oral, selective JAK1 inhibitor, Jyseleca (filgotinib 200 mg and 100 mg tablets), for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Moderna Begins COVID-19 Vaccine Study: Moderna, Inc. (MRNA - Free Report) announced that the phase III study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants. The phase III study, COVE (Coronavirus Efficacy), is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The study is expected to enroll 30,000 subjects.
Additionally, Moderna modified its contract with the Biomedical Advanced Research and Development Authority (BARDA). The modified contract represents an additional commitment of up to $472 million to support the late-stage clinical development, including the expanded phase III study, of its mRNA vaccine candidate, mRNA-1273, against COVID-19.
Emergent Signs Agreement With AstraZeneca for COVID-19 Vaccine: Emergent BioSolutions Inc. (EBS - Free Report) has signed an agreement with AstraZeneca. Per the agreement, Emergent will provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021. Earlier, the companies signed an $87-million contract in June for development services, performance and process qualification, raw materials, and an initial capacity reservation.
Dynavax Collaborates for COVID-19 Vaccine: Dynavax (DVAX - Free Report) announced a collaboration with Medigen Vaccine Biologics Corporation for developing a novel, adjuvanted COVID-19 vaccine candidate. The collaboration is evaluating the combination of the latter’s stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax’s advanced adjuvant CpG 101, which is present in the latter’s FDA-approved adult hepatitis B vaccine. The combination generated strong virus-neutralizing antibody responses in preclinical testing. Medigen anticipates initiating a phase I study evaluating the combination in September 2020.
Stay tuned for more pipeline and earnings updates.
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Biotech Stock Roundup: Amgen Reports Q2, GILD's CAR T Therapy Gets Approval & More
It was a busy week for the biotech sector with updates from most bigwigs. Amgen (AMGN - Free Report) reported better-than-expected second-quarter results. Apart from this, other regulatory and pipeline updates were in the spotlight.
Recap of the Week’s Most Important Stories:
Amgen Beats on Q2 Earnings and Sales: Amgen reported second-quarter 2020 earnings of $4.25 per share, which beat the Zacks Consensus Estimate of $3.81. Earnings rose 7% year over year. Total revenues of $6.21 billion in the quarter beat the Zacks Consensus Estimate of $6.18 billion. Higher sales of Otezla, Repatha and biosimilar products were offset by lower sales of other drugs including Prolia, Xgeva and Kyprolis due to COVID-19 and the erosion of mature brands from biosimilar/new competition. Amgen re-affirmed its previously issued sales guidance for 2020 while raising the earnings view range.
Gilead Gets FDA Approval for Tecartus: Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA granted accelerated approval to chimeric antigen receptor (CAR) T cell therapy, Tecartus, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval was based on results of ZUMA-2, a single-arm, open-label study, wherein 87% of patients responded to a single infusion of Tecartus, including 62% of patients achieving a complete response (CR). Among patients evaluable for safety, 18% experienced Grade 3 or higher cytokine release syndrome (CRS) and 37% experienced Grade 3 or higher neurologic toxicities.
Gilead and partner Galapagos NV (GLPG - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for its investigational, once-daily, oral, selective JAK1 inhibitor, Jyseleca (filgotinib 200 mg and 100 mg tablets), for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Moderna Begins COVID-19 Vaccine Study: Moderna, Inc. (MRNA - Free Report) announced that the phase III study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants. The phase III study, COVE (Coronavirus Efficacy), is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The study is expected to enroll 30,000 subjects.
Additionally, Moderna modified its contract with the Biomedical Advanced Research and Development Authority (BARDA). The modified contract represents an additional commitment of up to $472 million to support the late-stage clinical development, including the expanded phase III study, of its mRNA vaccine candidate, mRNA-1273, against COVID-19.
Emergent Signs Agreement With AstraZeneca for COVID-19 Vaccine: Emergent BioSolutions Inc. (EBS - Free Report) has signed an agreement with AstraZeneca. Per the agreement, Emergent will provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021. Earlier, the companies signed an $87-million contract in June for development services, performance and process qualification, raw materials, and an initial capacity reservation.
Emergent currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Dynavax Collaborates for COVID-19 Vaccine: Dynavax (DVAX - Free Report) announced a collaboration with Medigen Vaccine Biologics Corporation for developing a novel, adjuvanted COVID-19 vaccine candidate. The collaboration is evaluating the combination of the latter’s stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax’s advanced adjuvant CpG 101, which is present in the latter’s FDA-approved adult hepatitis B vaccine. The combination generated strong virus-neutralizing antibody responses in preclinical testing. Medigen anticipates initiating a phase I study evaluating the combination in September 2020.
Performance
The Nasdaq Biotechnology index lost 3.06% in the last five trading sessions. Among the biotech giants, Incyte lost 5.66% during this period. Over the past six months, shares of Regeneron have gained 83.39%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB Reports Q2, GILD Acquires Stake in Private Company & More)
What's Next in Biotech?
Stay tuned for more pipeline and earnings updates.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2019, while the S&P 500 gained and impressive +53.6%, five of our strategies returned +65.8%, +97.1%, +118.0%, +175.7% and even +186.7%.
This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
See their latest picks free >>