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Pharma Stock Roundup: FDA Authorization of Omicron Boosters, SNY's Xenpozyme & More
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This week, the FDA granted emergency approval to Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) COVID booster shots targeting the Omicron subvariants, BA.4 and BA.5 and approved Sanofi’s (SNY - Free Report) rare genetic disease drug, Xenpozyme. Novartis’ (NVS - Free Report) leukemia drug, Scemblix, was approved in Europe.
Recap of the Week’s Most Important Stories
FDA Authorizes Pfizer/Moderna’s Omicron Based Boosters: The FDA granted emergency use authorization to Pfizer/BioNTech and Moderna’s Omicron BA.4/BA.5-adapted bivalent vaccines for use as a single booster dose. These boosters can be given at least two months following primary or booster vaccination.
These “updated boosters” contain an mRNA component present in the original vaccine as well as an mRNA component, which is common in the Omicron BA.4 and BA.5 variants. While Moderna’s Omicron booster is approved for individuals 18 years of age and older, Pfizer/Moderna’s version is approved for people 12 and older.
Pfizer/BioNTech and Moderna had developed the Omicron BA.4/BA.5-adapted bivalent vaccines at the FDA’s recommendation a couple of months back as the subvariants, BA.4 and BA.5, are the most prevalent variants of concern in the United States as of now.
The companies’ filings seeking authorization of the updated boosters were based on clinical studies on their bivalent Omicron BA.1-adapted vaccines as well as pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines. Pfizer/BioNTech said the vaccines are available for shipping immediately while Moderna’s vaccines are expected to be available nationwide in the coming days.
Pfizer Completes Filing for Omicron Boosters in Europe: Pfizer completed the submission of conditional marketing authorization to the European Medicines Agency, seeking approval for its Omicron BA.4/BA.5-adapted bivalent COVID-19 booster vaccine for individuals 12 years of age and older.
The regulatory filings seeking approval for the Omicron boosters included preclinical, quality and manufacturing data from the Omicron BA.4/BA.5 adapted bivalent vaccine, as well as data from the phase II/III study evaluating Pfizer/BioNTech’s bivalent Omicron BA.1-adapted bivalent vaccine of a 30-µg booster dose. The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine exhibited a strong neutralizing antibody response in its preclinical studies, in comparison to Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the ancestral strain.
FDA Approves Sanofi’s Xenpozyme: The FDA approved Sanofi’s enzyme replacement therapy, Xenpozyme (olipudase alfa), for the treatment of adult and pediatric patients with non-Central Nervous System manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease. Xenpozyme becomes the only approved treatment in the United States for this disease. Xenpozyme is already approved in Japan and Europe for ASMD.
The FDA also granted priority review to Sanofi’s biologics license application (BLA) seeking approval of the novel recombinant factor VIII therapy, efanesoctocog alfa for the treatment of people with hemophilia A. The FDA’s decision on the BLA is expected on Feb 28, 2023. The BLA filing was based on data from the XTEND-1 pivotal phase III study. Sanofi is collaborating with Swedish Orphan Biovitrum for the development and commercialization of efanesoctocog alfa.
Novartis Gets Approval for Scemblix in Europe: Novartis announced that the European Commission has granted marketing approval to Scemblix (asciminib) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) in adult patients who are previously treated with two or more tyrosine kinase inhibitors (TKIs). The approval was based on data from the pivotal phase III ASCEMBL study. The FDA granted accelerated approval to Scemblix for treating adult patients with Ph+ CML-CP, previously treated with two or more TKIs, in October 2021.
The NYSE ARCA Pharmaceutical Index declined 4.1% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Authorization of Omicron Boosters, SNY's Xenpozyme & More
This week, the FDA granted emergency approval to Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) COVID booster shots targeting the Omicron subvariants, BA.4 and BA.5 and approved Sanofi’s (SNY - Free Report) rare genetic disease drug, Xenpozyme. Novartis’ (NVS - Free Report) leukemia drug, Scemblix, was approved in Europe.
Recap of the Week’s Most Important Stories
FDA Authorizes Pfizer/Moderna’s Omicron Based Boosters: The FDA granted emergency use authorization to Pfizer/BioNTech and Moderna’s Omicron BA.4/BA.5-adapted bivalent vaccines for use as a single booster dose. These boosters can be given at least two months following primary or booster vaccination.
These “updated boosters” contain an mRNA component present in the original vaccine as well as an mRNA component, which is common in the Omicron BA.4 and BA.5 variants. While Moderna’s Omicron booster is approved for individuals 18 years of age and older, Pfizer/Moderna’s version is approved for people 12 and older.
Pfizer/BioNTech and Moderna had developed the Omicron BA.4/BA.5-adapted bivalent vaccines at the FDA’s recommendation a couple of months back as the subvariants, BA.4 and BA.5, are the most prevalent variants of concern in the United States as of now.
The companies’ filings seeking authorization of the updated boosters were based on clinical studies on their bivalent Omicron BA.1-adapted vaccines as well as pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines. Pfizer/BioNTech said the vaccines are available for shipping immediately while Moderna’s vaccines are expected to be available nationwide in the coming days.
Pfizer Completes Filing for Omicron Boosters in Europe: Pfizer completed the submission of conditional marketing authorization to the European Medicines Agency, seeking approval for its Omicron BA.4/BA.5-adapted bivalent COVID-19 booster vaccine for individuals 12 years of age and older.
The regulatory filings seeking approval for the Omicron boosters included preclinical, quality and manufacturing data from the Omicron BA.4/BA.5 adapted bivalent vaccine, as well as data from the phase II/III study evaluating Pfizer/BioNTech’s bivalent Omicron BA.1-adapted bivalent vaccine of a 30-µg booster dose. The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine exhibited a strong neutralizing antibody response in its preclinical studies, in comparison to Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the ancestral strain.
FDA Approves Sanofi’s Xenpozyme: The FDA approved Sanofi’s enzyme replacement therapy, Xenpozyme (olipudase alfa), for the treatment of adult and pediatric patients with non-Central Nervous System manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease. Xenpozyme becomes the only approved treatment in the United States for this disease. Xenpozyme is already approved in Japan and Europe for ASMD.
The FDA also granted priority review to Sanofi’s biologics license application (BLA) seeking approval of the novel recombinant factor VIII therapy, efanesoctocog alfa for the treatment of people with hemophilia A. The FDA’s decision on the BLA is expected on Feb 28, 2023. The BLA filing was based on data from the XTEND-1 pivotal phase III study. Sanofi is collaborating with Swedish Orphan Biovitrum for the development and commercialization of efanesoctocog alfa.
Novartis Gets Approval for Scemblix in Europe: Novartis announced that the European Commission has granted marketing approval to Scemblix (asciminib) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) in adult patients who are previously treated with two or more tyrosine kinase inhibitors (TKIs). The approval was based on data from the pivotal phase III ASCEMBL study. The FDA granted accelerated approval to Scemblix for treating adult patients with Ph+ CML-CP, previously treated with two or more TKIs, in October 2021.
The NYSE ARCA Pharmaceutical Index declined 4.1% 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, all the stocks were in the red, with AstraZeneca declining the most (8.6%).
In the past six months, Lilly has gained the highest (18.6%) while Roche declined the most (14%).
(See the last pharma stock roundup here: NVS to Spin Off Sandoz; JNJ, MRK, ABBV’s FDA Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.