The FDA Calendar Review Dates Can Play a Big Role in Timing Your Trades, But Not the Way You May Think
08 January 2021 - 12:00AM
InvestorsHub NewsWire
New York, NY -- January 7,
2021 -- InvestorsHub NewsWire -- Traders News
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Amarin Corporation plc
(NASDAQ:
AMRN) only has one drug, Vascepa. It's a medication
that reduces strokes and heart attacks. Some say that Vascepa is
one of the most important developments in the prevention and
treatment of cardiovascular disease since
statins.
While Vascepa is an approved drug,
sold in the USA, ten months ago an American judge (the company is
based in Ireland) vacated some Amarin patents, opening the door for
generic competition. AMRN is still waiting for Vascepa approval in
the EU and anticipates a patent protected rollout of the product
there. Estimates for peak sales in the EU are at $2.8
billion.
Three months ago,
Northwest Biotherapeutics, Inc. (OTCQB:
NWBO) announced that the database for the Phase III
trial of DCVax®-L for Gliobastoma has been locked. The phase III
trial had been ongoing for 14 years and now independent
statisticians are tallying up the results. DCVax®-L is the only
product of consequence for NWBO, so the company’s future rides on
the clinicals results. On September 1, 2020 NWBO acquired
Flaskworks, a company that has developed and automated the
manufacturing of cell therapy products such as
DCVax®.
There are parties on both sides of
the NWBO and DCVax®-L prospects discussion with valid points to
make. Investors are examining the bullish and bearish cases to
determine which one best fits their investing
agenda.
See Traders News Source
FDA / PDUFA research resources for Biotech investors READ
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CytoDyn Inc. (OTCQB:
CYDY) is a late-stage biotechnology company developing
Vyrologix™, a CCR5 antagonist with the potential for multiple
therapeutic indications. The company has been studying the impact
of Vyrologix on Covid 19 patients. Nicholas J. Agresti, M.D. has
treated four patients, on ventilators, with great success and
written a paper detailing the results. The paper has been accepted
for publication in the Journal of Translational
Autoimmunity.
Nader Pourhassan, Ph.D., President
and Chief Executive Officer of CytoDyn, commented, “We are
appreciative of Dr. Agresti’s work and view his publication as a
validation of Vyrologix as an important potential therapeutic in
the treatment of seriously ill COVID-19 patients.
Enzolytics Inc. (OTCPINK:
ENZC) and BioClonetics Immunotherapeutics, Inc.
entered a non-binding letter of intent to combine the two entities
and pursue our joint mission to create therapeutics that are
effective and affordable for the treatment of some of the most
infectious and deadly diseases in the world, including HIV and the
Coronavirus.
According to a December letter to
shareholders:” Our new lab is being opened on the campus of Texas
A&M University in the University's Institute for Preclinical
Studies. Here we will expand our development capabilities for the
production of additional monoclonal antibodies targeting immutable
sites on the HIV and SARS-CoV-2 viruses. We have engaged an
artificial intelligence (AI) and genetics and molecular biology
data science team to curate the thousands of isolates (strains) now
known as existing in both the HIV virus and the SARS-CoV-2 virus.
This process will allow us to identify conserved, immutable targets
against which monoclonal antibodies are to be
produced.”
Our FDA Approval Calendar
and other biotech stock resources READ
MORE
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may be required https://tradersnewssource.com/fda-calendar/
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