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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
Vertex Pharmaceuticals Inc.
Tezacaftor/Ivacaftor Combination (NDA)
FDA decision on Tezacaftor/Ivacaftor Combo for the treatment of cystic fibrosis
02/28/2018
FDA approved SYMDEKO (Tezacaftor/Ivacaftor Combo) on Feb.12, 2018
KEMPHARM, INC
Apadaz (NDA resubmission)
FDA decision on Apadaz for the short-term management of acute pain.
02/23/2018
Roche Holding AG
Emicizumab (BLA)
FDA decision on Emicizumab for haemophilia A with inhibitors
02/23/2018
FDA approved Hemlibra, previously known as Emicizumab, on Nov.16, 2017
Apricus Biosciences, Inc.
Vitaros (NDA resubmission)
FDA decision on Vitaros, an on-demand topical cream, for the treatment of erectile dysfunction
02/17/2018
Exelixis, Inc.
CABOMETYX (sNDA)
FDA decision on CABOMETYX as first-line monotherapy for advanced renal cell carcinoma
02/15/2018
FDA approved CABOMETYX as first-line monotherapy on Dec.19, 2017.
Pacira Pharmaceuticals, Inc.
EXPAREL (sNDA)
FDA panel to review EXPAREL as a nerve block for regional analgesia
02/14/2018
Antares Pharma Inc.
Makena (sNDA)
FDA decision on Makena subcutaneous auto-injector for subcutaneous use to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past
02/14/2018
FDA approves Makena subcutaneous auto-injector
AMAG Pharmaceuticals Inc.
Makena (sNDA)
FDA decision on Makena subcutaneous auto-injector for subcutaneous use to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past
02/14/2018
FDA approves Makena subcutaneous auto-injector
Valeant Pharmaceuticals International
VRX, VRX.TO
PLENVU (NDA)
FDA decision on PLENVU for cleansing of the colon in preparation of colonoscopy
02/13/2018
Gilead Sciences Inc.
Bictegravir (NDA)
FDA decision on Bictegravir for the treatment of HIV-1 infection
02/12/2018
FDA approved Biktarvy (Bictegravir, Emtricitabine, Tenofovir Alafenamide) on Feb.7, 2018
Amgen Inc.
XGEVA (sBLA)
FDA decision to expand indication for XGEVA for prevention of skeletal-related events in patients with multiple myeloma
02/03/2018
FDA approved XGEVA for prevention of skeletal-related events in patients with multiple myeloma on Jan.5, 2018.
AMAG Pharmaceuticals Inc.
Feraheme (sNDA) resubmission
FDA decision on Feraheme for the treatment of all adult patients with iron deficiency anemia
02/02/2018
FDA approved Feraheme for the treatment of all adult patients with iron deficiency anemia on Feb.5, 2018
Sucampo Pharmaceuticals Inc.
AMITIZA (sNDA)
FDA decision on AMITIZA in children aged 6 to 17 years with pediatric functional constipation
01/28/2018
ARADIGM CORP
Linhaliq (NDA)
FDA decision on Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections
01/26/2018
FDA issued Complete response Letter for Linhaliq on Jan.29, 2018
Advanced Accelerator Applications S.A.
Lutathera (NDA resubmission)
FDA decision on Lutathera for the treatment of patients with gastroenteropancreatic neuroendocrine tumors
01/26/2018
FDA approves Lutathera for the treatment of patients with gastroenteropancreatic neuroendocrine tumors
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