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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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Date
Company Name
Ticker
Drug
Event
Outcome
Details
09/08/2015
Synageva BioPharma Corp.
Kanuma (BLA)
FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
09/05/2015
TESARO, Inc.
Oral Rolapitant (NDA)
FDA decision on oral Rolapitant for the prevention of chemotherapy-induced nausea and vomiting
09/05/2015
TESARO, Inc.
Oral Rolapitant (NDA)
FDA decision on Oral Rolapitant for prevention of chemotherapy-induced nausea and vomiting (C
08/27/2015
Amgen Inc.
Evolocumab (BLA)
FDA decision on Evolocumab for the treatment of high cholesterol
08/27/2015
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma.
08/27/2015
Amgen Inc.
Repatha (BLA)
FDA decision on Repatha for the treatment of high cholesterol
08/22/2015
Alkermes plc
Aripiprazole lauroxil (NDA)
FDA decision on Aripiprazole lauroxil for the treatment of schizophrenia
08/22/2015
Alkermes plc
Aripiprazole Lauroxil (NDA)
FDA decision on Aripiprazole Lauroxil for the treatment of schizophrenia
08/11/2015
EXELIXIS INC
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
07/26/2015
Amgen Inc.
Kyprolis (sNDA)
FDA decision on Kyprolis for the treatment of relapsed multiple myeloma
07/24/2015
Regeneron Pharmaceuticals
Praluent (BLA)
FDA decision on Praluent for the treatment of patients with hypercholesterolemia
07/09/2015
Eli Lilly And Co.
Necitumumab (BLA)
FDA panel to review Necitumumab for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer
07/05/2015
Vertex Pharmaceuticals Inc.
Lumacaftor / Ivacaftor combo
FDA decision on Lumacaftor / Ivacaftor combo in people with CF ages 12 and older who have two copies of the F508del mutation
06/22/2015
Bristol-Myers Squibb Co.
Opdivo (BLA)
FDA decision on Opdivo for the treatment of patients with advanced squamous non-small cell lung cancer after prior therapy
FDA approved Opdivo on Mar.4, 2015
06/11/2015
GlaxoSmithKline PLC
GSK.L, GSK
Mepolizumab (BLA)
FDA panel to review Mepolizumab as an add-on maintenance treatment for severe asthma with eosinophilic inflammation
FDA panel recommends approval of Mepolizumab for the treatment of adults with severe asthma
Pharma-062515.jpg Aquinox Pharmaceuticals Inc.'s (AQXP) phase II clinical trial investigating the ability of 200mg oral, once daily AQX-1125 to reduce pain in female patients with bladder pain syndrome/interstitial cystitis, or BPS/IC, has not met the statistical endpoint.
Pharma-062315.jpg Alcobra Ltd.(ADHD) is scheduled to present results from its phase II clinical trial of MDX in adolescents and adults with Fragile X Syndrome on Wednesday, June 24, 2015 at 8:00am Eastern Time.
Transition-Therapeutics-Inc-TTHI-062215.jpg Shares of Transition Therapeutics Inc. (TTHI) (TTH.TO) have gained nearly 25% in the last one month, as the company awaits phase II study results of its neuropsychiatric drug candidate - ELND005.
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As it turns out, drinking too much water could pose serious health risks, according to a new study. The study, published in the Clinical Journal of Sport Medicine, states that you should only drink water when you're thirsty to avoid exercise-associated hyponatremia (EAH), which occurs when a person drinks too much water when exercising.
Researchers of a new study have found that children with good verbal working memories are better at lying. The study, published in the Journal of Experimental Child Psychiatry, saw researchers test verbal working memories of 137 children between the ages of six and seven by asking them a series of trivia questions written on a card and told them that the answers to the questions were on the back.
The consumption of trans fats, most commonly used in processed foods to improve taste, texture and durability, may work to weaken the memory of young men, according to a new study. The study, published online in the journal PLOS ONE, evaluated data from 1,018 men and women, ages 20 to 85, who were asked to complete a dietary survey and memory test involving word recall.
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