Zacks analyst blog spotlights Sanofi, Merck, Novartis, Pfizer and J&J

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Chicago, IL – July 1, 2022 – Zacks.com announces the list of stocks featured in the analyst blog. Every day, Zacks Equity Research analysts discuss the latest news and events impacting stocks and financial markets. Stocks recently featured in the blog include: Sanofi SNY, Merck MRK, Novartis NVS, Pfizer PFE and J&J JNJ.

Here are highlights from Thursday’s analyst blog:

Pharma stock roundup: FDA, EU and more

This week, an FDA committee recommended updated booster shots of the COVID-19 vaccine to fight the Omicron variant. The European Commission (EC) has approved Sanofi two new drugs, Nexviadyme (avalglucosidase alfa) and Xenpozyme (olipudase alfa) as well as the expanded use of Merckis Keytruda and Novartis‘Cosentyx. Pfizer signed a new COVID-19 vaccine supply agreement with the US government. The FDA has granted Breakthrough Therapy Designation (BTD) to NOT A WORDmultiple myeloma candidate, talquetamab

Recap of the most important stories of the week

FDA committee recommends redesigning COVID boosters to target Omicron: The FDA’s Vaccines and Related Biologicals Advisory Committee (VRBPAC) has voted to recommend updated COVID-19 vaccine recalls that target the Omicron variant and its subvariants to improve vaccine efficacy. The VRBPAC committee voted 19 to 2, recommending modifying the current strain composition of available COVID-19 vaccines by incorporating genetic material from the Omicron variant into the modified boosters.

If the FDA follows the VRBPAC recommendation, which it usually does, vaccine makers Pfizer/BioNTech and Moderna will have to roll out modified recalls of their vaccines. Pfizer/BioNTech and Moderna are already developing Omicron-based COVID-19 vaccine boosters to address the rise of new and evolving Omicron subvariants. These Omicron-targeted vaccines have shown promise in clinical studies.

However, the vote did not specify whether the modified boosters should target the Omicron variant or both the Omicron as well as older ancestral strains of the virus. It was also unclear whether the modified boosters would target the newer Omicron subvariants, BA.4 and BA.5, which currently account for more than half of all COVID-19 cases in the United States.

Sanofi obtains the approval of two new drugs in Europe: The EC has approved Sanofi’s two new enzyme replacement therapies, Nexviadyme (avalglucosidase alfa) and Xenpozyme (olipudase alfa).

While Nexviadyme has been approved for the treatment of late-onset Pompe disease and childhood-onset Pompe disease, a rare degenerative muscle disorder, Xenpozyme (olipudase alfa) has been approved for the treatment of adult patients and pediatric patients with non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive and life-threatening genetic disorder.

Avalglucosidase alfa is already approved in the United States, Japan, Canada, Switzerland, Australia, Brazil, Taiwan and the United Arab Emirates as Nexviazyme. Xenpozyme is already approved in Japan for ASMD. An application for approval for olipudase alfa is pending in the United States, with a decision expected next week.

Keytruda from Merck and Cosentyx from Novartis obtain approvals for extended use in Europe: The EC has also approved Merck’s blockbuster cancer drug, Keytruda, for expanded use in the melanoma indication. Keytruda is now approved as an add-on treatment for adult and adolescent patients with stage IIB or IIC melanoma who have undergone complete resection.

In addition to stage IIB or IIC melanoma, the EC has approved a label extension of Keytruda to include adolescent patients aged 12 years and older with advanced melanoma and stage III melanoma (as adjuvant therapy after complete resection) . The drug is already approved for these advanced stages of the disease in adults in Europe.

The EC has approved Novartis’ blockbuster arthritis drug Cosentyx (secukinumab) for a new indication. The EC has now approved Cosentyx alone or in combination with methotrexate in the categories of juvenile idiopathic arthritis of enthesitis-related arthritis and juvenile psoriatic arthritis in patients aged six years and older whose disease has not responded adequately or cannot tolerate conventional treatment.

Pfizer’s New COVID Vaccine Supply Agreement with the US Government: Pfizer announced a new agreement with the US government to supply 105 million doses of its COVID-19 vaccine for a payment of $3.2 billion.

The deal includes its Omicron-tailored COVID-19 jabs if they are granted emergency use authorization by the FDA. The first 105 million doses are expected to be delivered in the fourth quarter of this year. The agreement also includes an option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.

Pfizer has already shared study data on its two Omicron-suitable vaccine candidates with regulators, including the FDA, and an EUA application is expected.

FDA breakthrough label for a new multiple myeloma candidate: The FDA has granted BTD to J&J’s pipeline candidate, talquetamab, for heavily pretreated patients with relapsed or refractory multiple myeloma. Talquetamab is a first bispecific T-cell engaging antibody using GPRC5D, a novel target for the treatment of patients with relapsed or refractory multiple myeloma. The designation is based on data from the Phase I/II MonumenTAL-1 study.

The NYSE ARCA Pharmaceutical Index is up 3.5% over the past five trading sessions.

All stocks were in the green for the past five trading sessions. Roche made the most progress (5.5%).

Over the past six months, Merck has risen the most (20.7%) while Roche has fallen the most (19.1%).

(See the latest roundup of pharmaceutical stocks here: Extended Use of ABBV, MRK, NVS Drugs, Other Updates by FDA OK)

What’s next in the pharmaceutical world?

Watch for regular pipeline and regulatory updates next week.

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Past performance is not indicative of future results. The potential for loss is inherent in any investment. This document is provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold any security. No recommendation or advice is given as to whether any investment is suitable for any particular investor. It should not be assumed that investments in the securities, companies, sectors or markets identified and described have been or will be profitable. All information is current as of the date hereof and is subject to change without notice. The views or opinions expressed may not reflect those of the company as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management of securities. These returns come from hypothetical portfolios composed of stocks with Zacks Rank = 1 that have been rebalanced monthly without transaction fees. These are not the returns of actual stock portfolios. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for more information on the performance figures displayed in this press release.

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