FDA Calendar

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
Adamis Pharmaceuticals Corp
Symjepi (sNDA)
FDA decision on low dose Symjepi (0.15mg) for the emergency treatment of anaphylaxis
Akcea Therapeutics Inc.
Volanesorsen (NDA)
FDA decision on Volanesorsen for the treatment of familial chylomicronemia syndrome (FCS).
Tetraphase Pharmaceuticals
Eravacycline (NDA)
FDA decision on Eravacycline for the treatment of complicated intra-abdominal infections
Kala Pharmaceuticals, Inc.
Inveltys (NDA)
FDA decision on Inveltys for post surgical pain and inflammation
Merck & Co Inc.
Lenvatinib (sNDA)
FDA decision on Lenvima for the potential first-line treatment of patients with unresectable hepatocellular carcinoma
Mallinckrodt plc
Stannsoporfin (NDA)
FDA decision on Stannsoporfin for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for small cell lung cancer
Amicus Therapeutics Inc.
Galafold (NDA)
FDA decision on Galafold for treatment of Fabry disease
Arbutus Biopharma Corp.
Patisiran (NDA)
FDA decision on Alnylam's Patisiran for hereditary ATTR (hATTR) amyloidosis
Alnylam Pharmaceuticals Inc.
Patisiran (NDA)
FDA decision on Patisiran for the treatment of hereditary ATTR (hATTR) amyloidosis
SIGA Technologies Inc
Oral formulation of TPOXX (NDA)
FDA decision on TPOXX for smallpox infection
Pain Therapeutics Inc
REMOXY ER (Resubmitted NDA)
FDA's final decision on REMOXY ER for Management of severe pain
Progenics Pharmaceuticals Inc
Azedra (NDA)
FDA decision on Azedra for the treatment of malignant and/or recurrent pheochromocytoma and paraganglioma
Insys Therapeutics, Inc.
Buprenorphine Sublingual Spray (NDA)
FDA decision on Buprenorphine Sublingual Spray for moderate-to-severe acute pain
Dermira Inc.
Glycopyrronium tosylate (NDA)
FDA decision on Glycopyrronium tosylate for primary axillary hyperhidrosis
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.
pharma-daily-051718.jpg Today's Daily Dose brings you news about Anika's accelerated share repurchase program; Esperion's phase III study results of bempedoic acid in patients with hypercholesterolemia; TherapeuticsMD and Teva's near-term catalysts.
pharma-daily-052218.jpg Today's Daily Dose brings you news about FDA approval of AstraZeneca's hyperkalemia drug; Dova's platelet booster Doptelet getting regulatory nod; the fifth indication for Amgen's Prolia securing thumbs-up; Sesen's encouraging three-month data from the VISTA trial and investors' concern and Nabriva's LEAP 2 study results.
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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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