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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
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
12/20/2018
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
12/19/2018
ADMA BIOLOGICS, INC.
BIVIGAM (Prior Approval Supplement)
FDA decision on BIVIGAM, an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency
12/18/2018
Roche Holding AG
TECENTRIQ (sBLA)
FDA decision on TECENTRIQ in combination with Avastin or bevacizumab, paclitaxel and carboplatin or chemotherapy for initial treatment of people with metastatic NSCLC
12/05/2018
Loxo Oncology, Inc.
Larotrectinib NDA
FDA decision on Larotrectinib for patients with locally advanced or metastatic solid tumors harboring NTRK gene fusion
11/26/2018
Aquestive Therapeutics Inc.
AQST-119 (NDA)
FDA decision on AQST-119 for erectile dysfunction
11/18/2018
Mallinckrodt plc
MNK-812 (NDA)
FDA panel to review MNK-812 for management of pain severe enough to require opioid analgesic
11/14/2018
Theravance Biopharma Inc.
YUPELRI (NDA)
FDA decision on YUPELRI for moderate to very severe COPD
11/13/2018
Mylan N.V.
YUPELRI (NDA)
FDA decision on YUPELRI for moderate to very severe COPD
11/13/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
11/09/2018
EyePoint Pharmaceuticals, Inc.
YUTIQ (NDA)
FDA decision on YUTIQt for non-infectious posterior segment uveitis
11/05/2018
FDA Approved YUTIQ on Oct.15, 2018
Coherus Biosciences, Inc.
CHS-1701 (Resubmitted BLA)
FDA decison on CHS-1701, a biosimilar version of Neulasta
11/03/2018
AcelRx Pharmaceuticals Inc.
DSUVIA (Resubmitted NDA)
FDA decision on DSUVIA for the management of acute moderate to severe pain in adults in medically monitored settings
11/03/2018
Trevena, Inc.
OLINVO (NDA)
FDA decision on OLINVO for the management of moderate to severe acute pain
11/02/2018
SAGE Therapeutics, Inc.
Brexanolone 5 mg/mL intravenous injection (NDA)
FDA panel to review Brexanolone for postpartum depression
11/02/2018


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