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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
Johnson & Johnson
Darzalex (sBLA)
FDA decision on Darzalex in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myelom
09/26/2019
GENMAB A/S
Darzalex (sBLA)
FDA decision on Darzalex in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma
09/26/2019
GlaxoSmithKline PLC
GSK.L, GSK
Nicotine oral spray OTC (NDA)
FDA panel to review Nicotine oral spray OTC to reduce withdrawal symptoms,
09/18/2019
AVADEL PHARMACEUTICALS PLC
AV001 (NDA)
FDA decision on AV001 for Hospital product
09/15/2019
Aimmune Therapeutics Inc.
AR101 (BLA)
FDA panel to review AR101 for Peanut Allergy
09/13/2019
Ardelyx, Inc
Tenapanor (NDA)
FDA decision on Tenapanor for patients with irritable bowel syndrome with constipation
09/12/2019
Xeris Pharmaceuticals Inc
Gvoke HypoPen(NDA)
FDA decision on Gvoke HypoPen for the treatment of severe hypoglycemi
09/10/2019
Celgene Corporation
Fedratinib (NDA)
FDA decision on Fedratinib for myelofibrosis
09/03/2019
FDA approved Fedratinib for myelofibrosis on Aug.16, 2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
09/02/2019
Nektar Therapeutics
NKTR-181 (NDA)
FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
08/29/2019
Intellipharmaceutics International
Oxycodone ER (Resubmitted NDA)
FDA decision on Oxycodone ER for management of severe chronic pain.
08/28/2019
Daiichi Sankyo Company Limited
DSKYF.PK
Quizartinib (NDA)
FDA decision on Quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia
08/25/2019
Nabriva Therapeutics
Lefamulin (NDA)
FDA decision on oral and IV formulations of Lefamulin for bacterial pneumonia
08/19/2019
FDA approves Xenleta (lefamulin)
Sarepta Therapeutics
Golodirsen (NDA)
FDA decision on Golodirsen for the treatment of patients with Duchenne muscular dystrophy (Duchenne) who have genetic mutations subject to skipping exon 53 of dystrophin gene
08/19/2019
FDA issues Complete Response Letter for Golodirsen on Aug 19
AbbVie
Upadacitinib (NDA)
FDA decision on Upadacitinib for the treatment of moderate to severe rheumatoid arthritis
08/19/2019
FDA Approves upadacitinib on Aug 16
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