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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
Indivior plc.
INDV.L
RBP-6000 (NDA)
FDA decision on RBP-6000 for the treatment of opioid use disorder.
11/30/2017
Kite Pharma, Inc.
Axicabtagene ciloleucel (KTE-C19) (BLA)
FDA decision on KTE-C19 for Non-Hodgkin Lymphoma
11/29/2017
FDA approved Yescarta (formerly KTE-C19) for Large B-Cell Lymphoma on Oct.18, 2017
Ultragenyx Pharmaceutical Inc
Recombinant human beta-glucuronidase (BLA)
FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
11/16/2017
FDA approved rhGUS, under brand name MEPSEVII, for MPS VII on Nov.15, 2017
Heron Therapeutics Inc.
CINVANTI (NDA)
FDA decision on CINVANTI for the prevention of chemotherapy-induced nausea and vomiting
11/12/2017
FDA approved CINVANTI on Nov.9, 2017
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
11/09/2017
FDA approves HEPLISAV-B for treatment of hepatitis B
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
FDA expanded approval of Sprycel to include treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) on Nov.10
Keryx Biopharmaceuticals Inc
Auryxia (sNDA)
FDA decision on Auryxia to include the treatment of iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease (
11/06/2017
FDA approved Auryxia for treatment of iron deficiency anemia in adults with chronic kidney disease, not on dialysis on Nov.7, 2017
Collegium Pharmaceutical, Inc
Xtampza ER (sNDA)
FDA decision on label change of Xtampza ER
11/04/2017
FDA approved sNDA for Xtampza ER on Nov.7, 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
FDA gave tentative approval for Pemetrexed, under brand name Pemfexy, on Oct.28, 2017
Johnson & Johnson
XARELTO (sNDA)
FDA decision for a 10 mg dose to reduce the risk of recurrent venous thromboembolism
10/28/2017
Tesaro Inc.
Rolapitant I.V (Resubmitted NDA)
FDA decision on Rolapitant I.V for prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy
10/25/2017
FDA approves Rolapitant I.V for prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy
PTC Therapeutics Inc.
Translarna (NDA)
FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
10/24/2017
FDA issued a Complete Response Letter for Translarna on Oct.25, 2017
Alexion Pharmaceuticals Inc.
Soliris (sBLA)
FDA decision on Soliris as a potential treatment for patients with refractory generalized myasthenia gravis (gMG)
10/23/2017
FDA approves Soliris for the treatment for patients with refractory generalized myasthenia gravis (gMG)
Johnson & Johnson
SIMPONI ARIA (sBLA)
FDA decision on SIMPONI ARIA for the treatment of adults living with active psoriatic arthritis
10/22/2017
Johnson & Johnson
SIMPONI ARIA (sBLA)
FDA decision on SIMPONI ARIA for the treatment of treatment of adults living with active ankylosing spondylitis
10/22/2017
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