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FDA Calendar

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PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Company Name
Ticker
Drug
Event
Date
Outcome
Details
Bristol-Myers Squibb Co.
Idecabtagene vicleucel (BLA)
FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/27/2021
bluebird bio Inc.
Idecabtagene vicleucel (BLA)
FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/27/2021
CytRx Corp.
Arimoclomol (NDA)
FDA decision on Arimoclomol for the treatment of Niemann-Pick disease Type C
03/17/2021
Biogen Inc.
Aducanumab (BLA)
FDA decision on Aducanumab for Alzheimer's Disease
03/07/2021
CorMedix Inc.
Defencath (NDA)
FDA decision on Defencath for the prevention of catheter related blood stream infections
02/28/2021
Athenex, Inc.
Oral Paclitaxel in combination with Encequidar (NDA)
FDA decision on Oral Paclitaxel in combination with Encequidar for the treatment of Metastatic Breast Cancer
02/28/2021
Blueprint Medicines
Pralsetinib (NDA)
FDA decision on Pralsetinib for the treatment of advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer
02/28/2021
Sarepta Therapeutics
Casimersen (NDA)
FDA decision on Casimersen for DMD amenable to Exon 45 skipping
02/25/2021
TG Therapeutics Inc.
TGTX, TGTX.OB
Umbralisib (NDA)
FDA decision on Umbralisib as a treatment for for patients with previously treated marginal zone lymphoma
02/15/2021
G1 Therapeutics, Inc.
Trilaciclib (NDA)
FDA decision on trilaciclib for small cell lung cancer patients being treated with chemotherapy
02/15/2021
Mallinckrodt plc
StrataGraft (BLA)
FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.
02/02/2021
Adamas Pharmaceuticals Inc
GOCOVRI (sNDA)
FDA decision on GOCOVRI as a treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy
02/01/2021
Adamas Pharmaceuticals Inc
GOCOVRI (sNDA)
FDA decision on GOCOVRI as treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy
02/01/2021
Protalix BioTherapeutics Inc.
PRX–102 (BLA)
FDA decision on PRX–102 for the treatment of Fabry disease
01/27/2021
Aurinia Pharmaceuticals Inc.
AUPH, AUP.V
Voclosporin (NDA)
FDA decision on Voclosporin for the treatment of lupus nephritis
01/22/2021

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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