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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
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
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
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
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
ARADIGM CORP
Linhaliq (NDA)
FDA panel to review Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections
01/11/2018
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
FDA approved SINUVA on Dec.11, 2017
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
Agile Therapeutics Inc.
Twirla (NDA resubmission)
FDA decision on contraceptive patch, Twirla
12/26/2017
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