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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
Otonomy Inc.
OTIPRIO(sNDA)
FDA decision on OTIPRIO for acute otitis externa
03/02/2018
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
Synergy Pharmaceuticals, Inc.
TRULANCE (sNDA)
FDA decision on TRULANCE for the treatment of adults with irritable bowel syndrome with constipation
01/24/2018
Ligand Pharmaceuticals Inc
LUXTURNA (BLA)
FDA decision on LUXTURNA for inherited retinal disease
01/12/2018
Spark Therapeutics
LUXTURNA (BLA)
FDA decision on LUXTURNA for treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
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
Valeant Pharmaceuticals International
VRX, VRX.TO
Luminesse (NDA)
FDA decision on Luminesse to be used Over-the-Counter as an eye drop to relieve redness of the eye due to minor eye irritations.
12/27/2017
Novo Nordisk A/S
Semaglutide (NDA)
FDA decision on Semaglutide to improve glycemic control in adults with type 2 diabetes.
12/05/2017
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
12/03/2017
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
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
11/10/2017
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
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