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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
TherapeuticsMD
TX-001HR (NDA)
FDA decision on TX-001HR for vasomotor symptoms due to menopause
10/28/2018
Jazz Pharmaceuticals plc
Xyrem oral solution, CIII (sNDA)
FDA decision on Xyrem oral solution, CIII, to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients
10/27/2018
Merck & Co Inc.
Doravirine (NDA)
FDA decision for use of Doravirine with lamivudine and tenofovir disoproxil fumarate for HIV
10/23/2018
Regeneron Pharmaceuticals
DUPIXENT (sBLA)
FDA decision on DUPIXENT for moderate-to-severe asthma
10/20/2018
Sanofi
DUPIXENT (sBLA)
FDA decision on DUPIXENT for moderate-to-severe asthma
10/20/2018
Akcea Therapeutics Inc.
Inotersen (NDA)
FDA decision on Tegsedi (Inotersen) for hereditary TTR amyloidosis (hATTR)
10/06/2018
IONIS PHARMACEUTICALS INC
Inotersen (NDA)
FDA decision on Tegsedi (Inotersen) for hereditary TTR amyloidosis (hATTR)
10/06/2018
Paratek Pharmaceuticals, Inc.
Oral and Intravenous Omadacycline (NDAs)
FDA decision on Oral and Intravenous Omadacycline to treat ABSSSI and CABP
10/06/2018
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.
10/05/2018
Verastem, Inc.
Duvelisib (NDA)
FDA decision on Duvelisib for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
10/05/2018
Roche Holding AG
HEMLIBRA (sBLA)
FDA decision on HEMLIBRA (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors
10/04/2018
Antares Pharma Inc.
XYOSTED injection(Resubmitted NDA)
FDA decision on XYOSTED injection for adult men with testosterone deficiency
09/29/2018
Insmed Inc
ALIS (Amikacin Liposome Inhalation Suspension) (NDA)
FDA decision on ALIS for adult patients with nontuberculous mycobacterial lung disease
09/28/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on Keytruda in combination with ALIMTA and platinum chemotherapy (carboplatin or cisplatin) for metastatic nonsquamous non-small cell lung cancer
09/23/2018
Teva Pharmaceutical Industries Limited
Fremanezumab (BLA)
FDA decision on Fremanezumab for the treatment of migraine
09/16/2018
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