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Pharma Stock Roundup: FDA Nod to AZN's Imfinzi for New Cancer & Other Updates
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This week, the FDA approved AstraZeneca’s (AZN - Free Report) PD-L1 inhibitor, Imfinzi as a combination regimen for treating advanced metastatic biliary tract cancer and granted Breakthrough Therapy Designation to Pfizer’s (PFE - Free Report) vaccine candidate to prevent Group B Streptococcus (GBS) infections. The regulatory body also said that it will conduct an advisory panel meeting to review GSK’s (GSK - Free Report) regulatory filing seeking approval for its pipeline candidate, daprodustat.
Recap of the Week’s Most Important Stories
FDA Nod to AstraZeneca’s Imfinzi for a New Indication: The FDA approved AstraZeneca’s PD-L1 inhibitor, Imfinzi plus chemotherapy for treating locally advanced or metastatic biliary tract cancer (BTC). Imfinzi is presently approved for unresectable, stage III non-small-cell lung cancer (NSCLC) and first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Imfinzi plus chemotherapy (gemcitabine plus cisplatin) became the first immunotherapy regimen to be approved for BTC. The approval was based on data from the TOPAZ-1 phase III study, which showed that Imfinzi plus chemotherapy led to a 20% reduction in the risk of death versus chemotherapy alone.
FDA to Hold Advisory Panel Meeting for GSK’s Daprodustat NDA: The FDA informed GSK that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application (NDA) seeking approval of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for anemia associated with chronic renal disease (CKD). The date of the advisory committee meeting is set for Oct 26, 2022. The FDA accepted GSK’s NDA for daprodustat in April and granted a standard review to the same. A decision is expected on Feb 1, 2023. A marketing authorization application (MAA) for daprodustat is also under review in Europe. Daprodustat is only approved in Japan as Duvroq for anemia associated with CKD.
FDA Breakthrough Tag for Pfizer’s Streptococcus Vaccine Candidate: The FDA granted Breakthrough Therapy Designation to Pfizer’s Group B Streptococcus (GBS) vaccine candidate, GBS6, for the prevention of invasive GBS infections due to vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy. GBS6 is being evaluated in the phase II study in healthy pregnant women aged 18 to 40 years in South Africa, the United Kingdom, and the United States. Interim data from this study formed the basis for the BTD tag.
The NYSE ARCA Pharmaceutical Index rose 0.6% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Nod to AZN's Imfinzi for New Cancer & Other Updates
This week, the FDA approved AstraZeneca’s (AZN - Free Report) PD-L1 inhibitor, Imfinzi as a combination regimen for treating advanced metastatic biliary tract cancer and granted Breakthrough Therapy Designation to Pfizer’s (PFE - Free Report) vaccine candidate to prevent Group B Streptococcus (GBS) infections. The regulatory body also said that it will conduct an advisory panel meeting to review GSK’s (GSK - Free Report) regulatory filing seeking approval for its pipeline candidate, daprodustat.
Recap of the Week’s Most Important Stories
FDA Nod to AstraZeneca’s Imfinzi for a New Indication: The FDA approved AstraZeneca’s PD-L1 inhibitor, Imfinzi plus chemotherapy for treating locally advanced or metastatic biliary tract cancer (BTC). Imfinzi is presently approved for unresectable, stage III non-small-cell lung cancer (NSCLC) and first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Imfinzi plus chemotherapy (gemcitabine plus cisplatin) became the first immunotherapy regimen to be approved for BTC. The approval was based on data from the TOPAZ-1 phase III study, which showed that Imfinzi plus chemotherapy led to a 20% reduction in the risk of death versus chemotherapy alone.
FDA to Hold Advisory Panel Meeting for GSK’s Daprodustat NDA: The FDA informed GSK that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application (NDA) seeking approval of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for anemia associated with chronic renal disease (CKD). The date of the advisory committee meeting is set for Oct 26, 2022. The FDA accepted GSK’s NDA for daprodustat in April and granted a standard review to the same. A decision is expected on Feb 1, 2023. A marketing authorization application (MAA) for daprodustat is also under review in Europe. Daprodustat is only approved in Japan as Duvroq for anemia associated with CKD.
FDA Breakthrough Tag for Pfizer’s Streptococcus Vaccine Candidate: The FDA granted Breakthrough Therapy Designation to Pfizer’s Group B Streptococcus (GBS) vaccine candidate, GBS6, for the prevention of invasive GBS infections due to vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy. GBS6 is being evaluated in the phase II study in healthy pregnant women aged 18 to 40 years in South Africa, the United Kingdom, and the United States. Interim data from this study formed the basis for the BTD tag.
The NYSE ARCA Pharmaceutical Index rose 0.6% 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, Roche rose the most (3.6%) while AstraZeneca declined the most (2.4%).
In the past six months, Lilly has gained the highest (18.6%) while Roche declined the most (11%).
(See the last pharma stock roundup here: FDA Authorization of Omicron Boosters, SNY’s Xenpozyme & More
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.