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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
Ligand Pharmaceuticals Inc
LUXTURNA (BLA)
FDA decision on LUXTURNA for inherited retinal disease
01/12/2018
Eli Lilly And Co.
Abemaciclib (NDA)
FDA decision on Abemaciclib for the treatment of advanced breast cancer
01/10/2018
Intersect ENT Inc
SINUVA implant (NDA)
FDA decision on SINUVA implant for patients with recurrent ethmoid sinus obstruction
01/07/2018
AEterna Zentaris Inc
AEZ.TO, AEZS
Macrilen (NDA resubmission)
FDA decision on Macrilen for the evaluation of growth hormone deficiency in adults
12/30/2017
Kite Pharma, Inc.
Axicabtagene ciloleucel (KTE-C19) (BLA)
FDA decision on KTE-C19 for Non-Hodgkin Lymphoma
11/29/2017
Ultragenyx Pharmaceutical Inc
Recombinant human beta-glucuronidase (BLA)
FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
11/16/2017
Bristol-Myers Squibb Co.
Sprycel (sNDA)
FDA decision on Sprycel to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia
11/09/2017
Eagle Pharmaceuticals Inc
Pemetrexed Injection (NDA)
FDA decision on Pemetrexed for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma
10/30/2017
Johnson & Johnson
XARELTO (sNDA)
FDA decision for a 10 mg dose to reduce the risk of recurrent venous thromboembolism
10/28/2017
PTC Therapeutics Inc.
Translarna (NDA)
FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
10/24/2017
Antares Pharma Inc.
QuickShot Testosterone (NDA)
FDA decision on QST as treatment for low testosterone associated with hypogonadism
10/20/2017
AcelRx Pharmaceuticals Inc.
DSUVIA (NDA)
FDA decision on DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting
10/12/2017
Mylan N.V.
Pegfilgrastim (BLA)
FDA decision on Pegfilgrastim as a proposed biosimilar to Amgen's Neulasta
10/09/2017
Flexion Therapeutics, Inc.
Zilretta (NDA)
FDA decision on Zilretta for treatment of patients with osteoarthritis of the knee
10/06/2017
Jazz Pharmaceuticals plc
VYXEOS (NDA)
FDA decision on VYXEOS for the treatment of acute myeloid leukemia
10/01/2017
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