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Biotech Stock Roundup: GILD Gets CRL, REGN Collaborates With RHHBY & More
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The biotech sector was in focus last week with normal pipeline updates and collaboration deals. While coronavirus-related news continues to grab headlines, collaboration deals were in focus too.
Recap of the Week’s Most Important Stories:
Gilead Expands Collaboration With Tango: Gilead Sciences, Inc. (GILD - Free Report) and Tango Therapeutics announced that they have expanded their existing collaboration agreement focused on the discovery, development and commercialization of innovative targeted immune evasion therapies for cancer.
The companies had earlier collaborated in 2018. Per the expanded multi-year collaboration, Tango will continue to leverage its proprietary, CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets. The number of targets covered has gone up to 15 from five. In exchange, Gilead will gain options to worldwide rights for programs directed at these targets over the next seven years. The company will also have the right to pay option extension fees for Tango to lead activities through early clinical development, for which the former will retain its option rights. Tango will have the option to co-develop and co-promote the lead products for up to five programs in the United States. Gilead will make a $125-million upfront payment to Tango and a $20-million equity investment in the same. Additionally, Gilead will have the right to option up to 15 programs over the seven-year collaboration for up to $410 million per program in opt-in, extension and milestone payments.
Separately, the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an experimental treatment for moderately to severely active rheumatoid arthritis (RA), which it is developing with Galapagos (GLPG - Free Report) . The agency has now requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. These studies are designed to assess if filgotinib has an impact on sperm parameters. Additionally, the FDA has some concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose. Both studies are fully recruited and top-line results are expected in the first half of 2021.
Bristol Myers, Dragonfly Team Up for Immunotherapy Program: Bristol Myers (BMY - Free Report) announced a definitive agreement with clinical-stage biopharmaceutical company, Dragonfly Therapeutics, Inc., for the investigational immunotherapy program. Per this agreement, Bristol Myers will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine, DF6002.
DF6002 is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. Bristol Myers will be responsible for the development and the subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. In exchange, it will make an upfront payment of $475 million to Dragonfly, which is also eligible to receive performance-based development, regulatory and commercial milestone payments. Additionally, Dragonfly will receive up to 24% royalties on worldwide net sales.
Regeneron, Roche Collaborate For COVID-19 Treatment: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Swiss pharma giant Roche announced that they have collaborated to develop, manufacture and distribute REGN-COV2, the investigational anti-viral antibody cocktail of the former. Per the agreement, Regeneron will distribute REGN-COV2 in the United States and Roche will be responsible for distribution outside the country. Under this agreement, both companies will jointly fund and execute the ongoing phase III prevention and phase I healthy volunteer safety studies, as well as any additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the United States following the initial European Medicines Agency (EMA) approval and conducting any additional studies specifically required for approval by regulators outside the country.
Mesoblast Gets Favorable Votes for Ryoncil: Mesoblast Limited (MESO - Free Report) announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted in the ratio of 9:1 in favor of the available data to support the efficacy of remestemcel-L (Ryoncil) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Although the FDA will consider the recommendation of the advisory committee, it is not bound by it. Ryoncil is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Per the FDA, the data provided by the company did not demonstrate the proposed effectiveness of the therapy as required. The proposed mechanism of action for remestemcel-L is a reduction in pathogenic inflammation mediated through the immunomodulatory activity of the mesenchymal stromal cells active ingredient. Nevertheless, the ODAC committee has now voted in favor of the candidate. It has been accepted for Priority Review by the FDA with an action date of Sep 30, 2020.
Novavax Begins COVID-19 Vaccine Study in South Africa: Novavax (NVAX - Free Report) announced that it has initiated a phase IIb clinical study in South Africa to evaluate the efficacy of NVX-CoV2373, its COVID-19 vaccine candidate. NVX CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology and includes its proprietary Matrix M adjuvant. The study is supported in part by a $15-million grant from the Bill & Melinda Gates Foundation. The randomized, observer-blinded, placebo-controlled study of NVX-CoV2373 will include two cohorts. One cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index lost 4.21% in the last five trading sessions. Among the biotech giants, Bristol-Myers gained 6.15% during this period. Over the past six months, shares of Regeneron have gained 50.94%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY & REGN Q2 Earnings, Gilead NDA for Coronavirus Drug)
What's Next in Biotech?
Stay tuned for more pipeline and earnings updates.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
Image: Bigstock
Biotech Stock Roundup: GILD Gets CRL, REGN Collaborates With RHHBY & More
The biotech sector was in focus last week with normal pipeline updates and collaboration deals. While coronavirus-related news continues to grab headlines, collaboration deals were in focus too.
Recap of the Week’s Most Important Stories:
Gilead Expands Collaboration With Tango: Gilead Sciences, Inc. (GILD - Free Report) and Tango Therapeutics announced that they have expanded their existing collaboration agreement focused on the discovery, development and commercialization of innovative targeted immune evasion therapies for cancer.
The companies had earlier collaborated in 2018. Per the expanded multi-year collaboration, Tango will continue to leverage its proprietary, CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets. The number of targets covered has gone up to 15 from five. In exchange, Gilead will gain options to worldwide rights for programs directed at these targets over the next seven years. The company will also have the right to pay option extension fees for Tango to lead activities through early clinical development, for which the former will retain its option rights. Tango will have the option to co-develop and co-promote the lead products for up to five programs in the United States. Gilead will make a $125-million upfront payment to Tango and a $20-million equity investment in the same. Additionally, Gilead will have the right to option up to 15 programs over the seven-year collaboration for up to $410 million per program in opt-in, extension and milestone payments.
Separately, the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an experimental treatment for moderately to severely active rheumatoid arthritis (RA), which it is developing with Galapagos (GLPG - Free Report) . The agency has now requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. These studies are designed to assess if filgotinib has an impact on sperm parameters. Additionally, the FDA has some concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose. Both studies are fully recruited and top-line results are expected in the first half of 2021.
Bristol Myers, Dragonfly Team Up for Immunotherapy Program: Bristol Myers (BMY - Free Report) announced a definitive agreement with clinical-stage biopharmaceutical company, Dragonfly Therapeutics, Inc., for the investigational immunotherapy program. Per this agreement, Bristol Myers will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine, DF6002.
DF6002 is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. Bristol Myers will be responsible for the development and the subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. In exchange, it will make an upfront payment of $475 million to Dragonfly, which is also eligible to receive performance-based development, regulatory and commercial milestone payments. Additionally, Dragonfly will receive up to 24% royalties on worldwide net sales.
Regeneron, Roche Collaborate For COVID-19 Treatment: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Swiss pharma giant Roche announced that they have collaborated to develop, manufacture and distribute REGN-COV2, the investigational anti-viral antibody cocktail of the former. Per the agreement, Regeneron will distribute REGN-COV2 in the United States and Roche will be responsible for distribution outside the country. Under this agreement, both companies will jointly fund and execute the ongoing phase III prevention and phase I healthy volunteer safety studies, as well as any additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the United States following the initial European Medicines Agency (EMA) approval and conducting any additional studies specifically required for approval by regulators outside the country.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Mesoblast Gets Favorable Votes for Ryoncil: Mesoblast Limited (MESO - Free Report) announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted in the ratio of 9:1 in favor of the available data to support the efficacy of remestemcel-L (Ryoncil) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Although the FDA will consider the recommendation of the advisory committee, it is not bound by it. Ryoncil is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Per the FDA, the data provided by the company did not demonstrate the proposed effectiveness of the therapy as required. The proposed mechanism of action for remestemcel-L is a reduction in pathogenic inflammation mediated through the immunomodulatory activity of the mesenchymal stromal cells active ingredient. Nevertheless, the ODAC committee has now voted in favor of the candidate. It has been accepted for Priority Review by the FDA with an action date of Sep 30, 2020.
Novavax Begins COVID-19 Vaccine Study in South Africa: Novavax (NVAX - Free Report) announced that it has initiated a phase IIb clinical study in South Africa to evaluate the efficacy of NVX-CoV2373, its COVID-19 vaccine candidate. NVX CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology and includes its proprietary Matrix M adjuvant. The study is supported in part by a $15-million grant from the Bill & Melinda Gates Foundation. The randomized, observer-blinded, placebo-controlled study of NVX-CoV2373 will include two cohorts. One cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index lost 4.21% in the last five trading sessions. Among the biotech giants, Bristol-Myers gained 6.15% during this period. Over the past six months, shares of Regeneron have gained 50.94%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY & REGN Q2 Earnings, Gilead NDA for Coronavirus Drug)
What's Next in Biotech?
Stay tuned for more pipeline and earnings updates.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>