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FDA Calendar

PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks.

The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date.

Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. So, having prior knowledge of the key dates goes a long way toward maximizing profit or minimizing loss while investing in the volatile biotech stocks.

Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Company Name
Drug
Event
Outcome
Details
Novartis AG
(NVS)
ENTRESTO (sNDA)
1H 2021
FDA decision on ENTRESTO for the proposed indication of heart failure with preserved ejection fraction
-
Karyopharm Therapeutics Inc.
(KPTI)
XPOVIO (selinexor) (sNDA)
Q1 2021
FDA decision on Selinexor for Patients with Multiple Myeloma After At Least One Prior Line of Therapy
FDA approved XPOVIO (Selinexor) for patients with multiple myeloma after at least one prior therapy on Dec.18, 2020-
CorMedix Inc.
(CRMD)
Defencath (NDA)
01/14/2021
FDA panel to review Defencath to be used as a catheter lock solution in hemodialysis patients
On Nov.18, 2020, the FDA cancelled the Advisory Committee to review Defencath-
Merck & Co Inc.
(MRK)
Vericiguat(NDA)
01/18/2021
FDA decision on Vericiguat in Patients with symptomatic chronic Heart Failure and Reduced Ejection Fraction
FDA approved Vericiguat under brand name Verquvo for heart failure with reduced ejection fraction on Jan.19, 2021-
Aurinia Pharmaceuticals Inc.
( AUPH, AUP.V)
Voclosporin (NDA)
01/22/2021
FDA decision on Voclosporin for the treatment of lupus nephritis
FDA approved LUPKYNIS (voclosporin) for adult patients with active Lupus Nephritis on Jan.22, 2021-
Amgen Inc.
(AMGN)
Nplate (sBLA)
01/28/2021
FDA decision on Nplate for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome
-
Adamas Pharmaceuticals Inc
(ADMS)
GOCOVRI (sNDA)
02/01/2021
FDA decision on GOCOVRI as treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy
-
Mallinckrodt plc
(MNK)
StrataGraft (BLA)
02/02/2021
FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.
-
Regeneron Pharmaceuticals
(REGN)
Evinacumab (BLA)
02/11/2021
FDA decision on Evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia
-
G1 Therapeutics, Inc.
(GTHX)
Trilaciclib (NDA)
02/15/2021
FDA decision on trilaciclib for small cell lung cancer patients being treated with chemotherapy
-

ALSO READ - COVID-19 Drugs In Development Calendar which lists Companies that are in Race to find a Treatment or Vaccine for the Novel Coronavirus.

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