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Pharma Stock Roundup: FDA Oks Omicron Jabs for Kids, MRK, MRNA Partner for Cancer Jab
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This week, the FDA granted emergency use authorization (EUA) to Omicron BA.4/BA.5 adapted COVID-19 booster vaccines of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) for use in children as young as five years old. Merck (MRK - Free Report) and Moderna announced the exercise of an option by the former to jointly develop a messenger RNA (mRNA)-based cancer vaccine. GSK plc’s (GSK - Free Report) phase III study of its respiratory syncytial virus (RSV) vaccine candidate for older adults met its primary endpoint.
Recap of the Week’s Most Important Stories
Merck, Moderna to Jointly Develop Cancer Vaccine: Merck exercised its option to jointly develop and commercialize Moderna’s personalized cancer vaccine (PCV) mRNA-4157/V940, per terms of the companies’ existing collaboration agreement. At present, Moderna is conducting a phase II study to evaluate mRNA-4157/V940 in combination with Merck’s blockbuster cancer drug, Keytruda as an adjuvant treatment for patients with high-risk melanoma. Data from the study is expected to be reported in the fourth quarter. Per the terms of the companies’ existing collaboration agreement, Merck will make a payment of $250 million to Moderna to exercise its option for personalized cancer vaccines, including mRNA-4157/V940.
FDA Grants Emergency Use for Pfizer & Moderna’s BA.4/BA.5 Boosters for Kids: Pfizer/BioNTech announced that the FDA has granted emergency use authorization (EUA) for a 10-µg booster dose of their bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine for children aged five through 11 years. Once the Disease Control and Prevention (CDC) gives its recommendation, Pfizer said the doses can be shipped immediately.
The FDA also granted EUA to Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, for use in children and adolescents 6 to 17 years of age. The authorization is for a 25 μg booster dose for children aged 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old
These “updated boosters” of Pfizer/Moderna contain an mRNA encoding the spike protein present in the original vaccine as well as an mRNA encoding the spike protein that is common in the Omicron BA.4 and BA.5 variants.
The FDA authorized Pfizer/BioNTech and Moderna’s BA.4/BA.5 boosters for people 12 and older for Pfizer and 18 and older for Moderna in late August.
Merck’s PAH Drug Succeeds in Phase III Study: Merck’s phase III STELLAR study, which evaluated its investigational pulmonary arterial hypertension (PAH) drug sotatercept compared to placebo when added to background therapy, achieved its primary and key secondary endpoints. In the study, sotatercept demonstrated significant improvement in exercise capacity, as measured by 6-minute walk distance (6MWD), and key secondary outcome measures. The data from the STELLAR study was also consistent with data from the phase II PULSAR study, which evaluated sotatercept in PAH patients. The PULSAR study also achieved its primary and key secondary endpoints with statistical significance.
GSK's RSV Vaccine Candidate Shows High Efficacy in Pivotal Study: GSK announced that positive data from a pivotal phase III study — AReSVi 006 — evaluating its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above were presented at the IDWeek 2022.
In the study, the RSV vaccine candidate showed overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD), thereby meeting the study’s primary endpoint. The vaccine also demonstrated consistent high efficacy against LRTD in severe disease (94.1%), in adults aged 70-79 years (93.8%) and in adults with underlying comorbidities (94.6%). Also, vaccine efficacy against LRTD was consistent across both RSV-A and RSV-B subtypes
GSK plans to file regulatory applications seeking approval of its RSV vaccine candidate for older adults in the second half of 2022.
The NYSE ARCA Pharmaceutical Index declined 2.3% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Oks Omicron Jabs for Kids, MRK, MRNA Partner for Cancer Jab
This week, the FDA granted emergency use authorization (EUA) to Omicron BA.4/BA.5 adapted COVID-19 booster vaccines of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) for use in children as young as five years old. Merck (MRK - Free Report) and Moderna announced the exercise of an option by the former to jointly develop a messenger RNA (mRNA)-based cancer vaccine. GSK plc’s (GSK - Free Report) phase III study of its respiratory syncytial virus (RSV) vaccine candidate for older adults met its primary endpoint.
Recap of the Week’s Most Important Stories
Merck, Moderna to Jointly Develop Cancer Vaccine: Merck exercised its option to jointly develop and commercialize Moderna’s personalized cancer vaccine (PCV) mRNA-4157/V940, per terms of the companies’ existing collaboration agreement. At present, Moderna is conducting a phase II study to evaluate mRNA-4157/V940 in combination with Merck’s blockbuster cancer drug, Keytruda as an adjuvant treatment for patients with high-risk melanoma. Data from the study is expected to be reported in the fourth quarter. Per the terms of the companies’ existing collaboration agreement, Merck will make a payment of $250 million to Moderna to exercise its option for personalized cancer vaccines, including mRNA-4157/V940.
FDA Grants Emergency Use for Pfizer & Moderna’s BA.4/BA.5 Boosters for Kids: Pfizer/BioNTech announced that the FDA has granted emergency use authorization (EUA) for a 10-µg booster dose of their bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine for children aged five through 11 years. Once the Disease Control and Prevention (CDC) gives its recommendation, Pfizer said the doses can be shipped immediately.
The FDA also granted EUA to Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, for use in children and adolescents 6 to 17 years of age. The authorization is for a 25 μg booster dose for children aged 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old
These “updated boosters” of Pfizer/Moderna contain an mRNA encoding the spike protein present in the original vaccine as well as an mRNA encoding the spike protein that is common in the Omicron BA.4 and BA.5 variants.
The FDA authorized Pfizer/BioNTech and Moderna’s BA.4/BA.5 boosters for people 12 and older for Pfizer and 18 and older for Moderna in late August.
Merck’s PAH Drug Succeeds in Phase III Study: Merck’s phase III STELLAR study, which evaluated its investigational pulmonary arterial hypertension (PAH) drug sotatercept compared to placebo when added to background therapy, achieved its primary and key secondary endpoints. In the study, sotatercept demonstrated significant improvement in exercise capacity, as measured by 6-minute walk distance (6MWD), and key secondary outcome measures. The data from the STELLAR study was also consistent with data from the phase II PULSAR study, which evaluated sotatercept in PAH patients. The PULSAR study also achieved its primary and key secondary endpoints with statistical significance.
GSK's RSV Vaccine Candidate Shows High Efficacy in Pivotal Study: GSK announced that positive data from a pivotal phase III study — AReSVi 006 — evaluating its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above were presented at the IDWeek 2022.
In the study, the RSV vaccine candidate showed overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD), thereby meeting the study’s primary endpoint. The vaccine also demonstrated consistent high efficacy against LRTD in severe disease (94.1%), in adults aged 70-79 years (93.8%) and in adults with underlying comorbidities (94.6%). Also, vaccine efficacy against LRTD was consistent across both RSV-A and RSV-B subtypes
GSK plans to file regulatory applications seeking approval of its RSV vaccine candidate for older adults in the second half of 2022.
The NYSE ARCA Pharmaceutical Index declined 2.3% 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.
Image Source: Zacks Investment Research
In the last five trading sessions, Merck rose the most (2.3%) while Pfizer declined the most (4.8%).
In the past six months, Lilly has gained the highest (7.5%) while Roche declined the most (22.4%).
(See the last pharma stock roundup here: EU Nod to AZN & RHHBY Drugs, FDA Updates for LLY & MRK)
What's Next in the Pharma World?
Watch out for J&J’s Q3 earnings release and regular pipeline and regulatory updates next week.