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
AstraZeneca PLC
ZS-9 (NDA resubmission)
FDA decision on ZS-9 for the treatment of hyperkalaemia
Neurocrine Biosciences Inc
FDA decision on INGREZZA for the treatment of tardive dyskinesia
Roche Holding AG
Lucentis (sBLA)
FDA decision on Lucentis for the treatment of myopic choroidal neovascularization
Regeneron Pharmaceuticals
Dupilumab (BLA)
FDA decision on Dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis
Dupilumab (BLA)
FDA decision on Dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis
Lexicon Pharmaceuticals Inc.
Telotristat Etiprate (NDA)
FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
Clovis Oncology, Inc.
Rucaparib (NDA)
FDA decision on Rucaparib for the treatment of advanced mutant BRCA ovarian cancer.
Genmab A/S
DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone (sBLA)
FDA decision on DARZALEX combination for relapsed multiple myeloma
Synergy Pharmaceuticals, Inc.
Plecanatide (NDA)
FDA decision on Plecanatide for the treatment of chronic idiopathic constipation
Biomarin Pharmaceutical Inc.
Brineura (Cerliponase Alfa) (BLA)
FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
FDA decision postponed to Apr.27, 2017
Anacor Pharmaceuticals, Inc.
Crisaborole topical ointment, 2% (NDA)
FDA decision on Crisaborole for treatment of mild-to-moderate atopic dermatitis in children and adults.
Vericel Corporation
FDA decision on MACI for the treatment of symptomatic cartilage defects of the knee in adult patients
Roche Holding AG
FDA decision on OCREVUS for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis
Advanced Accelerator Applications S.A.
Lutathera (NDA)
FDA decision on Lutathera for the treatment of gastro entero pancreatic neuroendocrine tumors
Cempra, Inc.
Solithera IV (NDA)
FDA decision on Solithera as a treatment for community-acquired bacterial pneumonia
Pharma-102016.jpg Shares of Cerulean Pharma Inc. (CERU) were up nearly 40% on Wednesday after the company announced a strategic collaboration with Novartis (NVS) to create nanoparticle-drug conjugates directed at up to five targets.
Pharma101816.jpg Intersect ENT Inc.'s pivotal phase III study of its investigational RESOLVE steroid releasing implant has met both primary efficacy endpoints namely, reduction in nasal congestion and polyp burden.
Pharma-101716.jpg Abeona Therapeutics Inc. (ABEO) is slated to present top-line results of the low-dose cohort for ABO-102 in Phase 1/2 clinical trial for Sanfilippo type A patients at the Orphan Drugs and Rare Disease Congress taking place in London, UK, from October 19th through October 20th.
A new study shows that caffeine does not seem to have adverse effects on individuals with irregular heartbeats. The results of the study were published online October 17 in the journal JAMA Internal Medicine. The study included 51 people with heart failure. The study was conducted by separating the people into two groups.
A new study shows that children in foster care are at higher risks of diseases. The study was conducted by Kristin Turney and Julie Steel and it was published in Health Daily News. Some of the identified risks included, mental health issues, ADHD, obesity, asthma, and depression to name a few. The study compared foster children to low-income and single parent families.
A new study suggests that the use of smokeless tobacco, or snus, may increase the risk of death in those with prostate cancer. The study, published in the International Journal of Cancer, found that those who used snus but did not smoke were three times more likely to die from prostate cancer than those who never used tobacco. For the study, researchers analyzed health check-up data.
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