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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
TherapeuticsMD
Yuvvexy (NDA)
FDA decision on Yuvvexy for the treatment of moderate-to-severe vaginal pain during sexual intercourse
05/07/2017
Novartis AG
LEE011 (NDA)
FDA decision on LEE011 for first-line treatment of HR+/HER2- advanced breast cancer
05/01/2017
Ariad Pharmaceuticals Inc
Brigatinib (NDA)
FDA decision on Brigatinib for metastatic ALK-positive non-small cell lung cancer
04/29/2017
Biomarin Pharmaceutical Inc.
Brineura (BLA)
FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
04/27/2017
AstraZeneca PLC
AZN.L, AZN
ZS-9 (NDA resubmission)
FDA decision on ZS-9 for the treatment of hyperkalaemia
04/18/2017
Neurocrine Biosciences Inc
INGREZZA (NDA)
FDA decision on INGREZZA for the treatment of tardive dyskinesia
04/11/2017
Roche Holding AG
Lucentis (sBLA)
FDA decision on Lucentis for the treatment of myopic choroidal neovascularization
04/11/2017
Regeneron Pharmaceuticals
Dupilumab (BLA)
FDA decision on Dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis
03/29/2017
Sanofi
Dupilumab (BLA)
FDA decision on Dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis
03/29/2017
Merck & Co Inc.
Keytruda (sBLA)
FD decision on Keytruda for treatment of patients with refractory classical Hodgkin lymphoma
03/15/2017
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy
03/02/2017
Lexicon Pharmaceuticals Inc.
Telotristat Etiprate (NDA)
FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
02/28/2017
Clovis Oncology, Inc.
Rucaparib (NDA)
FDA decision on Rucaparib for the treatment of advanced mutant BRCA ovarian cancer.
02/23/2017
Genmab A/S
GMXAY.PK, GNMSF.OB
DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone (sBLA)
FDA decision on DARZALEX combination for relapsed multiple myeloma
02/17/2017
Neurocrine Biosciences Inc
INGREZZA (NDA)
FDA panel to review INGREZZA for tardive dyskinesia
02/16/2017
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