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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
Adamis Pharmaceuticals Corp
Symjepi (sNDA)
FDA decision on low dose Symjepi (0.15mg) for the emergency treatment of anaphylaxis
09/03/2018
Akcea Therapeutics Inc.
Volanesorsen (NDA)
FDA decision on Volanesorsen for the treatment of familial chylomicronemia syndrome (FCS).
08/30/2018
Tetraphase Pharmaceuticals
Eravacycline (NDA)
FDA decision on Eravacycline for the treatment of complicated intra-abdominal infections
08/28/2018
Kala Pharmaceuticals, Inc.
Inveltys (NDA)
FDA decision on Inveltys for post surgical pain and inflammation
08/24/2018
Merck & Co Inc.
Lenvatinib (sNDA)
FDA decision on Lenvima for the potential first-line treatment of patients with unresectable hepatocellular carcinoma
08/24/2018
Mallinckrodt plc
Stannsoporfin (NDA)
FDA decision on Stannsoporfin for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice
08/22/2018
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for small cell lung cancer
08/16/2018
Amicus Therapeutics Inc.
Galafold (NDA)
FDA decision on Galafold for treatment of Fabry disease
08/13/2018
Arbutus Biopharma Corp.
Patisiran (NDA)
FDA decision on Alnylam's Patisiran for hereditary ATTR (hATTR) amyloidosis
08/11/2018
Alnylam Pharmaceuticals Inc.
Patisiran (NDA)
FDA decision on Patisiran for the treatment of hereditary ATTR (hATTR) amyloidosis
08/11/2018
SIGA Technologies Inc
Oral formulation of TPOXX (NDA)
FDA decision on TPOXX for smallpox infection
08/08/2018
Pain Therapeutics Inc
REMOXY ER (Resubmitted NDA)
FDA's final decision on REMOXY ER for Management of severe pain
08/07/2018
Progenics Pharmaceuticals Inc
Azedra (NDA)
FDA decision on Azedra for the treatment of malignant and/or recurrent pheochromocytoma and paraganglioma
07/30/2018
Insys Therapeutics, Inc.
Buprenorphine Sublingual Spray (NDA)
FDA decision on Buprenorphine Sublingual Spray for moderate-to-severe acute pain
07/28/2018
Dermira Inc.
Glycopyrronium tosylate (NDA)
FDA decision on Glycopyrronium tosylate for primary axillary hyperhidrosis
06/30/2018
may-may25.jpg Another busy week just rolled by - with many of the FDA-related actions and a couple of clinical trial announcements making headlines. Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
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A study conducted on mice by researchers of the University of Montreal, led by Jean-François Côté, have found a link between a certain protein called AXL and metastases in HER2-positive breast cancer.
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