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Posted On: 04/23/2020 3:19:23 PM
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UPDATE: These 21 companies are working on coronavirus treatments or vaccines -- here's where things stand
3:08 pm ET April 23, 2020 (MarketWatch)
By Jaimy Lee
The list includes Gilead Sciences and Moderna along with smaller biotechs
A mix of legacy drugmakers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.
COVID-19, which was first detected in December in Wuhan, China, has sickened more than 1.5 million people worldwide and killed more than 89,000 (http://www.marketwatch.com/story/coronavirus-update-15-million-cases-worldwide-89915-deaths-and-millions-of-americans-seek-jobless-benefits-2020-04-09). There are no Food and Drug Administration-approved vaccines or therapies for the disease although the regulator on March 29 granted an emergency use authorization (http://www.marketwatch.com/story/theres-scant-evidence-for-chloroquine-so-far-as-a-covid-19-drug-but-theres-already-a-shortage-2020-03-30) to hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19 patients. The emergency rules require patients to receive doses of the drugs donated to the U.S. federal stockpile by drug manufacturers or through clinical trials.
Read more of MarketWatch's coverage of COVID-19 (http://www.marketwatch.com/economy-politics/coronavirus).
In the U.S., many of the companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have also received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo that has provided millions of dollars in funding to vaccine makers. Other companies are funding trials by themselves or through partnerships with other life sciences companies.
Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:
Amgen and Adaptive Biotechnologies
Type: Treatment
Stage: Preclinical
Background: The very early-stage collaboration between Amgen Inc. (AMGN) and Adaptive Biotechnologies Corp. (ADPT) seeks to discover and develop antibodies that can be used to prevent or treat COVID-19. Financial terms of the exclusive collaboration will be finalized "in the coming weeks," the companies said April 2 ().
"Working with Adaptive and using their viral-neutralizing antibody platform will expedite our ability to bring a promising new medicine into clinical trials as quickly as possible," Robert Bradway, Amgen's chairman and CEO, said in a statement.
Year-to-date stock performance: Amgen's stock is down 9.9%; Adaptive's has dropped 15.3%.
BioNTech and Pfizer
Type: Vaccine
Stage: Preclinical
Name: BNT162
Background: On March 17, Pfizer (PFE) announced (http://www.marketwatch.com/story/biontech-pfizer-to-develop-covid-19-vaccine-candidate-2020-03-17) it would help develop and distribute BioNTech SE's (BNTX) COVID-19 vaccine candidate, though the deal excludes China. The companies plans to put the vaccine candidate into clinical trials in late April, in Germany and the U.S. As part of the deal, Pfizer will pay $185 million upfront (http://www.marketwatch.com/story/pfizer-discloses-185-million-upfront-payment-to-biontech-for-covid-19-vaccine-program-2020-04-09), with additional possible future milestone payments of up to $563 million.
BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China.
Pfizer and BioNTech for several years have said they would partner to develop mRNA-based influenza vaccines.
Year-to-date stock performances: Shares of BioNTech have soared 45.5%; Pfizer's stock is down 9.9%.
CalciMedica
Type: Treatment
Stage: Phase 2
Name: CM4620-IE
Background: CalciMedica Inc., a privately held clinical-stage company, is testing an investigational drug in 60 patients with severe COVID-19 pneumonia and who are at risk for their disease to progress to acute respiratory distress syndrome (ARDS). The open-label, Phase 2 trial is taking place at Regions Hospital in St. Paul, Minn., and Henry Ford Hospital in Detroit.
"It has the potential to prevent the development of ARDS in patients with severe COVID-19 pneumonia and reduce the need for ventilators at a time when there is a shortage of ventilators in health care facilities across the U.S.," Dr. Charles Bruen, a critical care and emergency physician at Regions Hospital, said in an April 9 news release.
CytoDyn
Type: Treatment
Stage: Phase 2 clinical trial
Name: leronlimab
Background: CytoDyn(CYDY) , a preclinical biotechnology company based in Vancouver, said March 31 (www.marketwatch.com/story/cytodyn-moves-forward-with-mid-stage-trial-for-experimental-covid-19-treatment-2020-03-31) that the FDA is allowing a mid-stage trial for its experimental drug leronlimab in COVID-19 patients to move forward. The investigational therapy has not been approved for any indications; for COVID-19, it's being proposed as a treatment for mild-to-moderate respiratory complications that occur in patients with the disease.
The randomized, double-blind, placebo-controlled study will test the efficacy and safety of leronlimab in 75 patients. CytoDyn had been studying the experimental therapy as a treatment for people with HIV and a form of metastatic breast cancer.
Year-to-date stock performance: CytoDyn's stock has soared 180.0%.
Dynavax Technologies
Type: Adjuvant platform for vaccines
Background: Dynavax Technologies Corp. (DVAX) said in March (http://www.marketwatch.com/story/dynavaxs-stock-rises-10-on-expanded-cepi-partnership-2020-03-26) that it's making its adjuvant technology available to companies developing COVID-19 vaccines through a partnership with CEPI. Dynavax's adjuvant technology can help provide an increased immune response to a vaccine; the biopharmaceutical company is also working with the University of Queensland, Australia, on vaccine development through a CEPI deal.
Year-to-date stock performance: Its stock is down 46.8%.
Gilead Sciences
Type: Treatment
Stage: Phase 3 clinical trials
Name: remdesivir
Background: Gilead Sciences Inc.(GILD) is a longtime drugmaker best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine.
Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild-to-moderate forms of pneumonia in people with the virus. The trial was given the go-ahead (http://www.marketwatch.com/story/gileads-antiviral-is-encouraging-as-coronavirus-candidate-but-isnt-likely-to-provide-long-term-shareholder-value-2020-02-03) by China's Food and Drug Administration in February.
Gilead in late March halted individual compassionate use requests (http://www.marketwatch.com/story/gilead-sciences-flooded-by-demand-for-redesivir-halts-compassionate-use-2020-03-23) for remdesivir as outbreaks worsened in the U.S., having provided the investigational therapy to 1,000 patients. "The system cannot support and process the overwhelming number of applications we have seen with COVID-19," Gilead CEO Daniel O'Day said March 28.
The company said in April it aims to have 500,000 treatment courses manufactured by October and 1 million by the end of 2020.
Gilead's clinical trials:
1. As of April 9, the National Institute of Allergy and Infectious Diseases is enrolling patients in a randomized, double-blind, placebo-controlled Phase 2 trial (https://clinicaltrials.gov/ct2/show/NCT04280705) evaluating 440 hospitalized patients with COVID-19 at up to 75 sites worldwide, including at three sites in Singapore and South Korea. However, the majority of the study locations are in the U.S. The study began Feb. 21 and is expected to conclude April 1, 2023.
Previously listed U.S. sites include the National Institutes of Health in Bethesda, Md., the University of Nebraska Medical Center in Omaha, the University of Texas Medical Branch in Galveston, and Providence Sacred Heart Medical Center in Spokane.
2. As of April 9, Gilead said a randomized, open-label Phase 3 trial (https://clinicaltrials.gov/ct2/show/NCT04292730?cond=covid&draw=2&rank=6) will evaluate remdesivir in 1,600 patients with moderate COVID-19. It previously said (http://www.marketwatch.com/story/gilead-increase-number-of-participants-in-two-trials-for-experimental-covid-19-treatment-2020-04-09) it would enroll 600 participants. The trial started enrolling patients in March, with results to come in May. The clinical trial listing states the study is taking place in 13 countries, including Hong Kong, Singapore, South Korea and the U.S.
3. As of April 9, Gilead said a randomized, open-label Phase 3 trial (https://clinicaltrials.gov/ct2/show/study/NCT04292899?cond=covid&draw=2&rank=5) will evaluate remdesivir in 2,400 patients with severe COVID-19. The drugmaker previously said it planned to include 400 participants in the trial. The trial starts enrolling patients in March, with results expected in May. The clinical trial listing states the study is taking place in Hong Kong, Singapore, South Korea and the U.S.
(MORE TO FOLLOW) Dow Jones Newswires
April 23, 2020 15:08 ET (19:08 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
UPDATE: These 21 companies are working on coronavirus treatments or vaccines -- here's where things stand
3:08 pm ET April 23, 2020 (MarketWatch)
By Jaimy Lee
The list includes Gilead Sciences and Moderna along with smaller biotechs
A mix of legacy drugmakers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.
COVID-19, which was first detected in December in Wuhan, China, has sickened more than 1.5 million people worldwide and killed more than 89,000 (http://www.marketwatch.com/story/coronavirus-update-15-million-cases-worldwide-89915-deaths-and-millions-of-americans-seek-jobless-benefits-2020-04-09). There are no Food and Drug Administration-approved vaccines or therapies for the disease although the regulator on March 29 granted an emergency use authorization (http://www.marketwatch.com/story/theres-scant-evidence-for-chloroquine-so-far-as-a-covid-19-drug-but-theres-already-a-shortage-2020-03-30) to hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19 patients. The emergency rules require patients to receive doses of the drugs donated to the U.S. federal stockpile by drug manufacturers or through clinical trials.
Read more of MarketWatch's coverage of COVID-19 (http://www.marketwatch.com/economy-politics/coronavirus).
In the U.S., many of the companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have also received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo that has provided millions of dollars in funding to vaccine makers. Other companies are funding trials by themselves or through partnerships with other life sciences companies.
Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:
Amgen and Adaptive Biotechnologies
Type: Treatment
Stage: Preclinical
Background: The very early-stage collaboration between Amgen Inc. (AMGN) and Adaptive Biotechnologies Corp. (ADPT) seeks to discover and develop antibodies that can be used to prevent or treat COVID-19. Financial terms of the exclusive collaboration will be finalized "in the coming weeks," the companies said April 2 ().
"Working with Adaptive and using their viral-neutralizing antibody platform will expedite our ability to bring a promising new medicine into clinical trials as quickly as possible," Robert Bradway, Amgen's chairman and CEO, said in a statement.
Year-to-date stock performance: Amgen's stock is down 9.9%; Adaptive's has dropped 15.3%.
BioNTech and Pfizer
Type: Vaccine
Stage: Preclinical
Name: BNT162
Background: On March 17, Pfizer (PFE) announced (http://www.marketwatch.com/story/biontech-pfizer-to-develop-covid-19-vaccine-candidate-2020-03-17) it would help develop and distribute BioNTech SE's (BNTX) COVID-19 vaccine candidate, though the deal excludes China. The companies plans to put the vaccine candidate into clinical trials in late April, in Germany and the U.S. As part of the deal, Pfizer will pay $185 million upfront (http://www.marketwatch.com/story/pfizer-discloses-185-million-upfront-payment-to-biontech-for-covid-19-vaccine-program-2020-04-09), with additional possible future milestone payments of up to $563 million.
BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China.
Pfizer and BioNTech for several years have said they would partner to develop mRNA-based influenza vaccines.
Year-to-date stock performances: Shares of BioNTech have soared 45.5%; Pfizer's stock is down 9.9%.
CalciMedica
Type: Treatment
Stage: Phase 2
Name: CM4620-IE
Background: CalciMedica Inc., a privately held clinical-stage company, is testing an investigational drug in 60 patients with severe COVID-19 pneumonia and who are at risk for their disease to progress to acute respiratory distress syndrome (ARDS). The open-label, Phase 2 trial is taking place at Regions Hospital in St. Paul, Minn., and Henry Ford Hospital in Detroit.
"It has the potential to prevent the development of ARDS in patients with severe COVID-19 pneumonia and reduce the need for ventilators at a time when there is a shortage of ventilators in health care facilities across the U.S.," Dr. Charles Bruen, a critical care and emergency physician at Regions Hospital, said in an April 9 news release.
CytoDyn
Type: Treatment
Stage: Phase 2 clinical trial
Name: leronlimab
Background: CytoDyn(CYDY) , a preclinical biotechnology company based in Vancouver, said March 31 (www.marketwatch.com/story/cytodyn-moves-forward-with-mid-stage-trial-for-experimental-covid-19-treatment-2020-03-31) that the FDA is allowing a mid-stage trial for its experimental drug leronlimab in COVID-19 patients to move forward. The investigational therapy has not been approved for any indications; for COVID-19, it's being proposed as a treatment for mild-to-moderate respiratory complications that occur in patients with the disease.
The randomized, double-blind, placebo-controlled study will test the efficacy and safety of leronlimab in 75 patients. CytoDyn had been studying the experimental therapy as a treatment for people with HIV and a form of metastatic breast cancer.
Year-to-date stock performance: CytoDyn's stock has soared 180.0%.
Dynavax Technologies
Type: Adjuvant platform for vaccines
Background: Dynavax Technologies Corp. (DVAX) said in March (http://www.marketwatch.com/story/dynavaxs-stock-rises-10-on-expanded-cepi-partnership-2020-03-26) that it's making its adjuvant technology available to companies developing COVID-19 vaccines through a partnership with CEPI. Dynavax's adjuvant technology can help provide an increased immune response to a vaccine; the biopharmaceutical company is also working with the University of Queensland, Australia, on vaccine development through a CEPI deal.
Year-to-date stock performance: Its stock is down 46.8%.
Gilead Sciences
Type: Treatment
Stage: Phase 3 clinical trials
Name: remdesivir
Background: Gilead Sciences Inc.(GILD) is a longtime drugmaker best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine.
Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild-to-moderate forms of pneumonia in people with the virus. The trial was given the go-ahead (http://www.marketwatch.com/story/gileads-antiviral-is-encouraging-as-coronavirus-candidate-but-isnt-likely-to-provide-long-term-shareholder-value-2020-02-03) by China's Food and Drug Administration in February.
Gilead in late March halted individual compassionate use requests (http://www.marketwatch.com/story/gilead-sciences-flooded-by-demand-for-redesivir-halts-compassionate-use-2020-03-23) for remdesivir as outbreaks worsened in the U.S., having provided the investigational therapy to 1,000 patients. "The system cannot support and process the overwhelming number of applications we have seen with COVID-19," Gilead CEO Daniel O'Day said March 28.
The company said in April it aims to have 500,000 treatment courses manufactured by October and 1 million by the end of 2020.
Gilead's clinical trials:
1. As of April 9, the National Institute of Allergy and Infectious Diseases is enrolling patients in a randomized, double-blind, placebo-controlled Phase 2 trial (https://clinicaltrials.gov/ct2/show/NCT04280705) evaluating 440 hospitalized patients with COVID-19 at up to 75 sites worldwide, including at three sites in Singapore and South Korea. However, the majority of the study locations are in the U.S. The study began Feb. 21 and is expected to conclude April 1, 2023.
Previously listed U.S. sites include the National Institutes of Health in Bethesda, Md., the University of Nebraska Medical Center in Omaha, the University of Texas Medical Branch in Galveston, and Providence Sacred Heart Medical Center in Spokane.
2. As of April 9, Gilead said a randomized, open-label Phase 3 trial (https://clinicaltrials.gov/ct2/show/NCT04292730?cond=covid&draw=2&rank=6) will evaluate remdesivir in 1,600 patients with moderate COVID-19. It previously said (http://www.marketwatch.com/story/gilead-increase-number-of-participants-in-two-trials-for-experimental-covid-19-treatment-2020-04-09) it would enroll 600 participants. The trial started enrolling patients in March, with results to come in May. The clinical trial listing states the study is taking place in 13 countries, including Hong Kong, Singapore, South Korea and the U.S.
3. As of April 9, Gilead said a randomized, open-label Phase 3 trial (https://clinicaltrials.gov/ct2/show/study/NCT04292899?cond=covid&draw=2&rank=5) will evaluate remdesivir in 2,400 patients with severe COVID-19. The drugmaker previously said it planned to include 400 participants in the trial. The trial starts enrolling patients in March, with results expected in May. The clinical trial listing states the study is taking place in Hong Kong, Singapore, South Korea and the U.S.
(MORE TO FOLLOW) Dow Jones Newswires
April 23, 2020 15:08 ET (19:08 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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