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
Synageva BioPharma Corp.
Kanuma (BLA)
FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
Oral Rolapitant (NDA)
FDA decision on oral Rolapitant for the prevention of chemotherapy-induced nausea and vomiting
Oral Rolapitant (NDA)
FDA decision on Oral Rolapitant for prevention of chemotherapy-induced nausea and vomiting (C
Amgen Inc.
Evolocumab (BLA)
FDA decision on Evolocumab for the treatment of high cholesterol
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma.
Amgen Inc.
Repatha (BLA)
FDA decision on Repatha for the treatment of high cholesterol
Alkermes plc
Aripiprazole lauroxil (NDA)
FDA decision on Aripiprazole lauroxil for the treatment of schizophrenia
Alkermes plc
Aripiprazole Lauroxil (NDA)
FDA decision on Aripiprazole Lauroxil for the treatment of schizophrenia
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
Amgen Inc.
Kyprolis (sNDA)
FDA decision on Kyprolis for the treatment of relapsed multiple myeloma
Regeneron Pharmaceuticals
Praluent (BLA)
FDA decision on Praluent for the treatment of patients with hypercholesterolemia
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
Vertex Pharmaceuticals Inc.
ORKAMBI (Lumacaftor / Ivacaftor combo NDA)
FDA decision on ORKAMBI for people with CF ages 12 and older who have two copies of the F508del mutation
FDA approved ORKAMBI on July 2, 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
GlaxoSmithKline PLC
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-070615.jpg Shares of Versartis Inc. (VSAR) rose more than 29% on Monday as investors welcomed the news of the removal of FDA partial clinical hold on the company's Investigational New Drug Application for VRS-317 in growth hormone deficiency children.
Pharmadaily2-070215.jpg Shares of Applied Genetic Technologies Corp. (AGTC) surged over 17% on Thursday following a broad collaboration and license agreement with Biogen Inc. (BIIB) to develop gene-based therapies for multiple ophthalmic diseases.
Pharmadaily3-070215.jpg TRACON Pharmaceuticals (TCON) is all set to receive a $3 million milestone payment from its partner Santen Pharmaceutical Co., following the filing of an Investigational New Drug Application with the FDA for the initiation of clinical studies for DE-122 in patients with wet AMD.
Some people may react more severely to poison ivy than others, according to a new study from researchers at Pennsylvania State University at Hershey. The researchers collected data about the varying degrees of severity that arise from poison ivy rashes. They discovered that about one in every four people has no reaction at all to the rash, which occurs as a result of contacting urushiol oil.
Having weight loss surgery may be more effective in reducing type 2 Diabetes symptoms than lifestyle changes, according to a new study from researchers at University of Pittsburgh Medical Center. For the study the researchers collected data from 61 type 2 diabetes patients between the ages of 25 and 55. Each of the study participants was assigned one of three treatments.
The Stella And Chewy's brand has recalled a selection of their pet food items due to possible listeria contamination. The recall has been ordered by the Maryland Department of Agriculture last week after the contaminate was discovered in some of their products during a routine test. The product in question is their Chicken Freeze-Dried Dinner Patties.
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