For Immediate Release
Chicago, IL – September 25, 2020 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include J&J
JNJ
, Pfizer
PFE
, AstraZeneca
AZN
, Sanofi
SNY
and GlaxoSmithKline
GSK
.
Here are highlights from Thursday’s Analyst Blog:
Pharma Stock Outlook: Covid-19 Phase-3 Trial Edition
J&J announced the start of a pivotal late-stage study on its potential coronavirus vaccine. Meanwhile, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency gave positive recommendations, granting marketing approval to several drugs this week.
Recap of the Week’s Most Important Stories
J&J Launches Late-Stage Studies on Coronavirus Vaccine:
J&J initiated a pivotal phase III study (ENSEMBLE) on its potential COVID-19 vaccine candidate, JNJ-78436735. The study will enroll 60,000 adult participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. The large pivotal phase III study will evaluate the safety and efficacy of a single dose of JNJ-78436735 in contrast to two doses being tested for rival vaccines of Pfizer/BioNTech, AstraZeneca /Oxford University and Moderna that are also in late-stage development. J&J expects to file for emergency use authorization of its vaccine candidate in early 2021. J&J initiated the ENSEMBLE study in collaboration with BARDA and NIAID.
FDA Grants Priority Review to Pfizer’s Xalkori sNDA:
The FDA accepted Pfizer’s supplemental new drug (sNDA) seeking approval of its oncology medicine Xalkori for a new indication. The sNDA is seeking approval of Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. With the FDA granting a priority review to the sNDA, a decision is expected in January 2021. Xalkori is presently approved to treat ALK-positive metastatic NSCLC.
Sanofi/Glaxo to Supply 300M Doses of Coronavirus Vaccine in Europe:
Sanofi and GlaxoSmithKline announced an
advanced purchase agreement
with the European Union to supply up to 300 million doses of the COVID-19 vaccine, if approved. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology.
The companies also signed an agreement to supply up to 72 million doses of the vaccine to Canada, if approved.
The final decision by the European Union on these products is expected in the coming months.
The NYSE ARCA Pharmaceutical Index declined 2.9% in the last five trading sessions.
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.
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