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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
GW Pharmaceuticals PLC
GWPH, GWP.L
Epidiolex (NDA)
FDA decision on Epidiolex for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
06/27/2018
Achaogen Inc.
Plazomicin (NDA)
FDA decision on Plazomicin for the treatment of complicated urinary tract infections, and bloodstream infections
06/25/2018
scPharmaceuticals Inc.
Furoscix (505(b)(2) NDA)
FDA decision on Furoscix for treatment of worsening, or decompensated, heart failure outside of the inpatient setting
06/23/2018
Dova Pharmaceuticals, Inc.
Avatrombopag (NDA)
FDA decision on Avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease
05/21/2018
Amgen Inc.
Aimovig (BLA)
FDA decision on Aimovig for the prevention of migraine
05/17/2018
Lipocine Inc
TLANDO (NDA resubmission)
FDA decision on TLANDO for the proposed indication of testosterone replacement therapy in adult males for hypogonadism
05/08/2018
Seattle Genetics Inc.
ADCETRIS (sBLA)
FDA decision on expanded use of ADCETRIS for the frontline treatment of advanced classical Hodgkin lymphoma
05/01/2018
Otonomy Inc.
OTIPRIO(sNDA)
FDA decision on OTIPRIO for acute otitis externa
03/02/2018
Aerie Pharmaceuticals, Inc.
Rhopressa (NDA)
FDA decision on Rhopressa for the treatment of patients with open-angle glaucoma or ocular hypertension
02/28/2018
FDA approved Rhopressa on Dec.18, 2017
La Jolla Pharmaceutical Co
LJPC-501 (angiotensin II) (NDA)
FDA decion on LJPC-501 or the treatment of hypotension in adults with distributive or vasodilatory shock
02/28/2018
FDA approved Giapreza, formerly known as LJPC-501, on Dec.21, 2017
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
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.
AMAG Pharmaceuticals Inc.
Makena subcutaneous auto-injector (sNDA)
FDA decision on subcutaneous version of Makena to reduce the risk of preterm birth
02/14/2018
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.
Sucampo Pharmaceuticals Inc.
AMITIZA (sNDA)
FDA decision on AMITIZA in children aged 6 to 17 years with pediatric functional constipation
01/28/2018
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