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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
Lexicon Pharmaceuticals Inc.
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019
Sanofi
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019
Aerie Pharmaceuticals, Inc.
Roclatan (NDA)
FDA decision on Roclatan for patients with open-angle glaucoma, retina diseases
03/14/2019
Bausch Health Companies Inc.
BHC, BHC.TO
Loteprednol etabonate ophthalmic gel (NDA)
FDA decision on Loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery
02/25/2019
Alexion Pharmaceuticals Inc.
ALXN1210 (BLA)
FDA decision on ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria
02/18/2019
MOTIF BIO PLC
Iclaprim (NDA)
FDA decision on Iclaprim for acute bacterial skin and skin structure infections
02/13/2019
Evolus Inc.
DWP-450(Resubmitted BLA)
FDA decision on DWP-450 for treatment of moderate to severe glabellar lines
02/02/2019
Aquestive Therapeutics Inc.
APL-130277 (NDA)
FDA decision on APL-130277 to overcome episodic off periods in Parkinson's disease
01/29/2019
Immunomedics Inc.
Sacituzumab govitecan (BLA)
FDA decision on Sacituzumab govitecan for treatment of metastatic triple-negative breast cancer
01/18/2019
Acorda Therapeutics Inc.
INBRIJA (NDA)
FDA decision on INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
01/05/2019
Portola Pharmaceuticals Inc.
Andexxa Prior Approval Supplement
FDA decision on Andexxa for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed
12/31/2018
Roche Holding AG
Baloxavir Marboxil (NDA)
FDA decision on Baloxavir Marboxil for the treatment of acute, uncomplicated influenza in people 12 years and older
12/24/2018
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
12/20/2018
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
12/19/2018
Roche Holding AG
TECENTRIQ (sBLA)
FDA decision on TECENTRIQ in combination with Avastin or bevacizumab, paclitaxel and carboplatin or chemotherapy for initial treatment of people with metastatic NSCLC
12/05/2018
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