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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
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
Aurinia Pharmaceuticals Inc.
AUPH, AUP.V
Voclosporin (NDA)
FDA decision on Voclosporin for the treatment of lupus nephritis
01/22/2021
Merck & Co Inc.
Vericiguat(NDA)
FDA decision on Vericiguat in Patients with symptomatic chronic Heart Failure and Reduced Ejection Fraction
01/20/2021
scPharmaceuticals Inc.
FUROSCIX (Resubmitted NDA)
FDA decision on FUROSCIX or the treatment of worsening heart failure due to congestion
12/30/2020
Athenex, Inc.
Tirbanibulin Ointment (NDA)
FDA decision on Tirbanibulin Ointment for the treatment of actinic keratosis
12/30/2020
Osmotica Pharmaceutical Corp
Arbaclofen ER (Resubmitted NDA)
FDA decision on Arbaclofen ER for the treatment of spasticity in patients with MS
12/29/2020
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

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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