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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
Mylan N.V.
MYL-1402O (BLA)
FDA decision on MYL-1402O, a proposed biosimilar to Avastin
12/27/2020
Urovant Sciences Ltd.
Vibegron (NDA)
FDA decision on Vibegron for the treatment of overactive bladder
12/26/2020
AstraZeneca PLC
AZN.L, AZN
Roxadustat (NDA)
FDA decision on Roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients
12/20/2020
Myovant Sciences Ltd
Relugolix (NDA)
FDA decision on once-daily, oral Relugolix for the treatment of men with advanced prostate cancer
12/20/2020
FibroGen Inc.
Roxadustat (NDA)
FDA decision on Roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients
12/20/2020
Amgen Inc.
ABP 798 (BLA)
FDA decision on ABP 798 (biosimilar rituximab) for Non-Hodgkin's lymphoma and Rheumatoid arthritis
12/19/2020
MacroGenics Inc.
Margetuximab (BLA)
FDA decision on Margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy
12/18/2020
Alnylam Pharmaceuticals Inc.
Lumasiran (NDA)
FDA decision on Lumasiran for the treatment of primary hyperoxaluria type 1 (PH1)
12/03/2020
Biocryst Pharmaceuticals Inc
Berotralstat (BCX7353) (NDA)
FDA decision on berotralstat for prevention of hereditary angioedema (HAE) attacks
12/03/2020
Y-mAbs Therapeutics, Inc.
Danyelza (BLA)
FDA decision on Danyelza for the treatment of patients with relapsed/refractory high-risk neuroblastoma
11/30/2020
RHYTHM PHARMACEUTICALS, INC.
Setmelanotide (NDA)
FDA decision on Setmelanotide for pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity
11/27/2020
Revance Therapeutics, Inc.
DAXI (BLA)
FDA decision on DAXI in the treatment of moderate to severe glabellar (frown) lines
11/25/2020
Liquidia Technologies Inc.
LIQ861 (NDA)
FDA decision on LIQ861 for the treatment of pulmonary arterial hypertension
11/24/2020
Roche Holding AG
Nnew formulation of Xofluza (NDA)
FDA decision on Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours
11/23/2020
Roche Holding AG
New formulation of Xofluza as one-dose granules for oral suspension (NDA)
FDA decision on new formulation of Xofluza treat the flu (influenza) in people 12 years of age and older
11/23/2020

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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