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Pharma Stock Roundup: FDA Approves PFE & MRK's Oral Pills for COVID & Other Drugs
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This week, the FDA granted emergency approval to Pfizer (PFE - Free Report) and Merck’s (MRK - Free Report) oral COVID antiviral pills, Paxlovid and molnupiravir, respectively. The regulatory agency also approved AstraZeneca’s (AZN - Free Report) asthma medicine, Tezspire (tezepelumab), Novartis’ (NVS - Free Report) LDL-C–lowering siRNA-based therapy, Leqvio (inclisiran) and Glaxo’s (GSK - Free Report) long-acting injectable therapy, Apretudefor HIV prevention.
Recap of the Week’s Most Important Stories
FDA Approves Pfizer and Merck’s Oral COVID Pills: The FDA granted Emergency Use Authorization (EUA) to Pfizer’s promising oral antiviral candidate, Paxlovid in combination with low-dose ritonavir to treat mild-to-moderate COVID-19 in adult and pediatric patients at increased risk of hospitalizations or death. Pfizer expects to begin delivering Paxlovid immediately. Paxlovid’s approval was based on clinical data from an interim analysis of a phase II/III study, EPIC-HR study. Data from the study showed that Paxlovid (administered) reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness compared to placebo within three days of symptom onset. Similar benefits were observed in patients treated within five days of symptom onset.
The FDA also granted EUA to Merck and partner Ridgeback Biotherapeutics’ similar oral antiviral pill, molnupiravir for treating high-risk adults with mild-to-moderate COVID-19. However, Merck’s pill can only be prescribed for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. It cannot also be prescribed as the first treatment for patients hospitalized due to COVID-19 or for pregnant women. The authorization of molnupiravir was based on data from the phase III MOVe-OUT study. Data from the final analysis of the MOVe-OUT study showed that the medicine reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild-or-moderate COVID-19, which was less than 50% as previously reported, per interim data announced in October.
Paxlovid and molnupiravir are antiviral medicines, which can be prescribed as at-home treatments to help fight mild-to-moderate COVID-19 infection. It can help prevent hospitalization in patients with a mild-to-moderate form of the disease but at high risk of severe COVID-19 and thus lower some of the pressure facing the healthcare and hospital systems.
FDA Approves AstraZeneca and Amgen’s Tezepelumab: The FDA approved Amgen and AstraZeneca’s monoclonal antibody, Tezspire (tezepelumab), for the treatment of severe asthma. The approval for Tezspire was based on data from the PATHFINDER clinical program and included the pivotal phase III NAVIGATOR study. Regulatory applications seeking approval of Tezspire are under regulatory review in the EU and Japan.
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending the approval of AstraZeneca’s drug Saphnelo to treat moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE), the most common form of lupus. The drug was approved in the United States and Japan in August and September this year, respectively.
The FDA accepted and granted priority review to AstraZeneca’s supplemental biologics license application (sBLA) seeking approval of rare disease drug Ultomiris for generalized myasthenia gravis (gMG). The FDA will give its decision in the second quarter of 2022. Ultomiris, a long-acting C5 complement inhibitor, was added to AstraZeneca’s portfolio with this year’s acquisition of Alexion and is already approved to treat paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
FDA Approves Glaxo’s HIV Injection for PrEP: The FDA approved Glaxo’s long-acting injectable form of cabotegravir drug for the prevention of HIV infection, also called pre-exposure prophylaxis or PrEP. The drug, to be marketed as Apretude in the United States, is the first and only long-acting injectable therapy approved for HIV prevention. It will reduce the daily administration of currently available oral pills for PrEP to as few as six injections a year. An oral formulation of cabotegravir, with the trade name of Vocabria, is already approved in combination with J&J’s Edurant (oral rilpivirine) for the short-term treatment of HIV-1 infection. A combination of long-acting injectable cabotegravir and Edurant is approved as Cabenuva for the treatment of HIV-1 infection in virologically suppressed adults.
Novartis to Buy Gene Therapy Company: Novartis announced a definitive agreement to acquire London, U.K.-based gene therapy company Gyroscope Therapeutics for an upfront payment of $800 million. The acquisition will add Gyroscope Therapeutics’ one-time gene therapy candidate, GT005, to Novartis’ pipeline. GT005 is being developed in phase II to treat geographic atrophy, a leading cause of blindness, for which there are no approved treatments. In addition to the upfront payment, Gyroscope Therapeutics will be entitled to potential additional milestone payments of up to $700 million.
The FDA granted approval to Novartis’ small interfering RNA (siRNA) therapy, Leqvio (inclisiran), to lower LDL-C or “bad” cholesterol. The injection is to be given as an initial dose and then two maintenance doses a year. With the approval, Leqvio becomes the first LDL-C–lowering siRNA-based therapy approved for treating atherosclerotic cardiovascular disease (ASCVD). Novartis received marketing authorization for Leqvio from the European Commission in December 2020.
Novartis signed an option, collaboration and license agreement with BeiGene, per which it will obtain the development and commercialization rights to the latter’s late-stage cancer candidate, ociperlimab, if the option is exercised. Per the terms, Novartis will make an upfront payment of $300 million to BeiGene while the latter will also be entitled to earn a fee of $700 million if the option is exercised before late 2023.
Novartis also announced disappointing top-line results from phase III studies, PEARL 1 and PEARL 2, on ligelizumab in chronic spontaneous urticaria (CSU). Data showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at week 12 but not versus Xolair (omalizumab).
Pfizer to Test 3-Dose COVID-19 Vaccine Regimen in Kids: Pfizer and BioNTech are planning to test a third 3 µg of their COVID-19 vaccine, at least two months after the second dose of Comirnaty in children aged six months to five years for better protection against COVID-19. The decision was taken after a routine review of an ongoing clinical study by the external independent data monitoring committee (DMC). A pre-specified immunogenicity analysis of the data by the DMC from a subset of a phase II/III study population showed that the COVID-19 vaccine failed to demonstrate non-inferior immunogenicity levels in two to five years age group compared to 16 to 25 years aged individuals.
The CHMP recommended approval for Pfizer’s three drugs — somatrogon for pediatric growth hormone deficiency, Prevnar-20, its pneumococcal 20-valent conjugate vaccine, and Lorviqua as a first-line treatment for ALK-positive advanced non-small-cell lung cancer. A decision related to the potential approval of these drugs from the European Commission is expected next year.
Pfizer & BioNTech announced an agreement with the European Commission (EC) to supply more than 200 million additional doses of their COVID-19 vaccine, Comirnaty. The additional doses will be delivered in 2022. With the latest option exercise, the companies now have agreements to supply more than 650 million doses to EC member states in 2022.
The NYSE ARCA Pharmaceutical Index declined 0.9% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Approves PFE & MRK's Oral Pills for COVID & Other Drugs
This week, the FDA granted emergency approval to Pfizer (PFE - Free Report) and Merck’s (MRK - Free Report) oral COVID antiviral pills, Paxlovid and molnupiravir, respectively. The regulatory agency also approved AstraZeneca’s (AZN - Free Report) asthma medicine, Tezspire (tezepelumab), Novartis’ (NVS - Free Report) LDL-C–lowering siRNA-based therapy, Leqvio (inclisiran) and Glaxo’s (GSK - Free Report) long-acting injectable therapy, Apretudefor HIV prevention.
Recap of the Week’s Most Important Stories
FDA Approves Pfizer and Merck’s Oral COVID Pills: The FDA granted Emergency Use Authorization (EUA) to Pfizer’s promising oral antiviral candidate, Paxlovid in combination with low-dose ritonavir to treat mild-to-moderate COVID-19 in adult and pediatric patients at increased risk of hospitalizations or death. Pfizer expects to begin delivering Paxlovid immediately. Paxlovid’s approval was based on clinical data from an interim analysis of a phase II/III study, EPIC-HR study. Data from the study showed that Paxlovid (administered) reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness compared to placebo within three days of symptom onset. Similar benefits were observed in patients treated within five days of symptom onset.
The FDA also granted EUA to Merck and partner Ridgeback Biotherapeutics’ similar oral antiviral pill, molnupiravir for treating high-risk adults with mild-to-moderate COVID-19. However, Merck’s pill can only be prescribed for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. It cannot also be prescribed as the first treatment for patients hospitalized due to COVID-19 or for pregnant women. The authorization of molnupiravir was based on data from the phase III MOVe-OUT study. Data from the final analysis of the MOVe-OUT study showed that the medicine reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild-or-moderate COVID-19, which was less than 50% as previously reported, per interim data announced in October.
Paxlovid and molnupiravir are antiviral medicines, which can be prescribed as at-home treatments to help fight mild-to-moderate COVID-19 infection. It can help prevent hospitalization in patients with a mild-to-moderate form of the disease but at high risk of severe COVID-19 and thus lower some of the pressure facing the healthcare and hospital systems.
FDA Approves AstraZeneca and Amgen’s Tezepelumab: The FDA approved Amgen and AstraZeneca’s monoclonal antibody, Tezspire (tezepelumab), for the treatment of severe asthma. The approval for Tezspire was based on data from the PATHFINDER clinical program and included the pivotal phase III NAVIGATOR study. Regulatory applications seeking approval of Tezspire are under regulatory review in the EU and Japan.
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending the approval of AstraZeneca’s drug Saphnelo to treat moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE), the most common form of lupus. The drug was approved in the United States and Japan in August and September this year, respectively.
The FDA accepted and granted priority review to AstraZeneca’s supplemental biologics license application (sBLA) seeking approval of rare disease drug Ultomiris for generalized myasthenia gravis (gMG). The FDA will give its decision in the second quarter of 2022. Ultomiris, a long-acting C5 complement inhibitor, was added to AstraZeneca’s portfolio with this year’s acquisition of Alexion and is already approved to treat paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
FDA Approves Glaxo’s HIV Injection for PrEP: The FDA approved Glaxo’s long-acting injectable form of cabotegravir drug for the prevention of HIV infection, also called pre-exposure prophylaxis or PrEP. The drug, to be marketed as Apretude in the United States, is the first and only long-acting injectable therapy approved for HIV prevention. It will reduce the daily administration of currently available oral pills for PrEP to as few as six injections a year. An oral formulation of cabotegravir, with the trade name of Vocabria, is already approved in combination with J&J’s Edurant (oral rilpivirine) for the short-term treatment of HIV-1 infection. A combination of long-acting injectable cabotegravir and Edurant is approved as Cabenuva for the treatment of HIV-1 infection in virologically suppressed adults.
Novartis to Buy Gene Therapy Company: Novartis announced a definitive agreement to acquire London, U.K.-based gene therapy company Gyroscope Therapeutics for an upfront payment of $800 million. The acquisition will add Gyroscope Therapeutics’ one-time gene therapy candidate, GT005, to Novartis’ pipeline. GT005 is being developed in phase II to treat geographic atrophy, a leading cause of blindness, for which there are no approved treatments. In addition to the upfront payment, Gyroscope Therapeutics will be entitled to potential additional milestone payments of up to $700 million.
The FDA granted approval to Novartis’ small interfering RNA (siRNA) therapy, Leqvio (inclisiran), to lower LDL-C or “bad” cholesterol. The injection is to be given as an initial dose and then two maintenance doses a year. With the approval, Leqvio becomes the first LDL-C–lowering siRNA-based therapy approved for treating atherosclerotic cardiovascular disease (ASCVD). Novartis received marketing authorization for Leqvio from the European Commission in December 2020.
Novartis signed an option, collaboration and license agreement with BeiGene, per which it will obtain the development and commercialization rights to the latter’s late-stage cancer candidate, ociperlimab, if the option is exercised. Per the terms, Novartis will make an upfront payment of $300 million to BeiGene while the latter will also be entitled to earn a fee of $700 million if the option is exercised before late 2023.
Novartis also announced disappointing top-line results from phase III studies, PEARL 1 and PEARL 2, on ligelizumab in chronic spontaneous urticaria (CSU). Data showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at week 12 but not versus Xolair (omalizumab).
Pfizer to Test 3-Dose COVID-19 Vaccine Regimen in Kids: Pfizer and BioNTech are planning to test a third 3 µg of their COVID-19 vaccine, at least two months after the second dose of Comirnaty in children aged six months to five years for better protection against COVID-19. The decision was taken after a routine review of an ongoing clinical study by the external independent data monitoring committee (DMC). A pre-specified immunogenicity analysis of the data by the DMC from a subset of a phase II/III study population showed that the COVID-19 vaccine failed to demonstrate non-inferior immunogenicity levels in two to five years age group compared to 16 to 25 years aged individuals.
The CHMP recommended approval for Pfizer’s three drugs — somatrogon for pediatric growth hormone deficiency, Prevnar-20, its pneumococcal 20-valent conjugate vaccine, and Lorviqua as a first-line treatment for ALK-positive advanced non-small-cell lung cancer. A decision related to the potential approval of these drugs from the European Commission is expected next year.
Pfizer & BioNTech announced an agreement with the European Commission (EC) to supply more than 200 million additional doses of their COVID-19 vaccine, Comirnaty. The additional doses will be delivered in 2022. With the latest option exercise, the companies now have agreements to supply more than 650 million doses to EC member states in 2022.
The NYSE ARCA Pharmaceutical Index declined 0.9% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, AbbVie rose the most (1%) while Pfizer declined the most (4.2%).
In the past six months, Pfizer has recorded the maximum gain (53.4%) while Novartis has declined the most (6.3%)
(See the last pharma stock roundup here: PFE Announces Arena Buyout, LLY Ups 2021 View & More)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.