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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
Immunomedics Inc.
Sacituzumab govitecan (BLA)
FDA decision on Sacituzumab govitecan for treatment of metastatic triple-negative breast cancer
01/18/2019
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
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
11/09/2018
EyePoint Pharmaceuticals, Inc.
Durasert micro-insert (NDA)
FDA decision on Durasert micro-insert for non-infectious posterior segment uveitis
11/05/2018
EyePoint Pharmaceuticals, Inc.
Durasert (NDA)
FDA decision on Durasert for posterior segment uveitis
11/05/2018
Coherus Biosciences, Inc.
CHS-1701 (Resubmitted BLA)
FDA decison on CHS-1701, a biosimilar version of Neulasta
11/03/2018
Coherus Biosciences, Inc.
CHS-1701 (resubmitted NDA)
FDA decision on CHS-1701 for Neulasta
11/03/2018
AcelRx Pharmaceuticals Inc.
DSUVIA (Resubmitted NDA)
FDA decision on DSUVIA for the management of acute moderate to severe pain in adults in medically monitored settings
11/03/2018
Trevena, Inc.
OLINVO (NDA)
FDA panel to review OLINVO for management of moderate to severe acute pain
11/02/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous NSCLC
10/30/2018
Regeneron Pharmaceuticals
cemiplimab (BLA)
FDA decision on cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
10/28/2018
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
pharma-july-072018.jpg As another week comes to a close, let's take a look back at some of the stories that made headlines in the pharma space, and look ahead to what's in store in the coming week.
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