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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
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA decision on Lumateperone for the treatment of schizophrenia
12/27/2019
DURECT Corp.
POSIMIR (Resubmitted NDA)
FDA decision on POSIMIR for post-operative pain relief depot product
12/27/2019
Alkermes plc
Vumerity (diroximel fumarate) (NDA)
FDA decision on diroximel fumarate for Relapsing Remitting Multiple Sclerosis
12/25/2019
AVADEL PHARMACEUTICALS PLC
AV001 (NDA)
FDA decision on AV001 for Hospital product
12/15/2019
Acceleron Pharma, Inc
Luspatercept (BLA)
FDA decision on Luspatercept for adult patients with beta-thalassemia-associated anemia
12/04/2019
Celgene Corporation
Luspatercept (BLA)
FDA decision on Luspatercept for the treatment of MDS and Beta-Thalassemia-Associated Anemias
12/04/2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
12/02/2019
Aquestive Therapeutics Inc.
Riluzole Oral Film (NDA)
FDA decision on Riluzole Oral Film as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis
11/30/2019
Agile Therapeutics Inc.
Twirla (Resubmitted NDA)
FDA decision on Twirla for use as a low-dose combined hormonal contraceptive patch
11/16/2019
Amarin Corp Plc
Vascepa (sNDA)
FDA panel to review expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study
11/14/2019
Lipocine Inc
TLANDO (resubmitted NDA)
FDA decision on TLANDO as testosterone replacement therapy in adult males for conditions associated with hypogonadism
11/09/2019
Roche Holding AG
Xofluza (sNDA)
FDA decision on Xofluza for the treatment of influenza in people at high risk of complications
11/04/2019
RedHill Biopharma Ltd.
Talicia (NDA)
FDA decision on Talicia for treatment of H. pylori infection.
11/02/2019
Adamis Pharmaceuticals Corp
ZIMHI (naloxone) Injection (NDA)
FDA decision on ZIMHI for the treatment of opioid overdose
10/31/2019
Agile Therapeutics Inc.
Twirla (Resubmitted NDA)
FDA panel to review Twirla for use as a low-dose combined hormonal contraceptive patch
10/30/2019
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