FDA Calendar

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
Mallinckrodt plc
StrataGraft (BLA)
FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.
Adamas Pharmaceuticals Inc
FDA decision on GOCOVRI as treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy
Aurinia Pharmaceuticals Inc.
Voclosporin (NDA)
FDA decision on Voclosporin for the treatment of lupus nephritis
Merck & Co Inc.
FDA decision on Vericiguat in Patients with symptomatic chronic Heart Failure and Reduced Ejection Fraction
scPharmaceuticals Inc.
FUROSCIX (Resubmitted NDA)
FDA decision on FUROSCIX or the treatment of worsening heart failure due to congestion
Athenex, Inc.
Tirbanibulin Ointment (NDA)
FDA decision on Tirbanibulin Ointment for the treatment of actinic keratosis
Osmotica Pharmaceutical Corp
Arbaclofen ER (Resubmitted NDA)
FDA decision on Arbaclofen ER for the treatment of spasticity in patients with MS
Mylan N.V.
MYL-1402O (BLA)
FDA decision on MYL-1402O, a proposed biosimilar to Avastin
Urovant Sciences Ltd.
Vibegron (NDA)
FDA decision on Vibegron for the treatment of overactive bladder
AstraZeneca PLC
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
Myovant Sciences Ltd
Relugolix (NDA)
FDA decision on once-daily, oral Relugolix for the treatment of men with advanced prostate cancer
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
Amgen Inc.
ABP 798 (BLA)
FDA decision on ABP 798 (biosimilar rituximab) for Non-Hodgkin's lymphoma and Rheumatoid arthritis
MacroGenics Inc.
Margetuximab (BLA)
FDA decision on Margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy
Alnylam Pharmaceuticals Inc.
Lumasiran (NDA)
FDA decision on Lumasiran for the treatment of primary hyperoxaluria type 1 (PH1)

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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