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
Yuvvexy (NDA)
FDA decision on Yuvvexy for the treatment of moderate-to-severe vaginal pain during sexual intercourse
Novartis AG
LEE011 (NDA)
FDA decision on LEE011 for first-line treatment of HR+/HER2- advanced breast cancer
Ariad Pharmaceuticals Inc
Brigatinib (NDA)
FDA decision on Brigatinib for metastatic ALK-positive non-small cell lung cancer
Biomarin Pharmaceutical Inc.
Brineura (BLA)
FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
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
Merck & Co Inc.
Keytruda (sBLA)
FD decision on Keytruda for treatment of patients with refractory classical Hodgkin lymphoma
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy
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
Neurocrine Biosciences Inc
FDA panel to review INGREZZA for tardive dyskinesia
Pharma-120916.jpg Shares of Horizon Pharma plc (HZNP) plunged over 22% on failure of the company's phase III trial of Actimmune in Friedreich's ataxia to meet its primary endpoint.
Pharma-120716.jpg Shares of Voyager Therapeutics Inc. (VYGR) surged over 35% in after-hours on Wednesday, following positive interim results from phase Ib trial of VY-AADC01 for advanced Parkinson's disease.
Pharma-120616.jpg Shares of Cerecor Inc. (CERC) plunged over 13% on Monday on disappointing top-line clinical results from its phase II clinical trial of CERC-501 for smoking cessation.
Older adults who suffer from dementia, or mild cognitive impairment, may benefit from aerobic exercise, according to a new study. The study, to be presented Wednesday at the Radiological Society of North America, included 16 people with an average age of 63, who did aerobic workouts on a treadmill, stationary bike or elliptical training. They worked out four times a week for six months.
The Food and Drug Administration has given permission for large-scale, Phase 3 clinical trials of MDMA— a final step before the possible approval of ecstasy as a prescription drug to treat posttraumatic stress disorder. The New York Times uses the example of an American soldier, C.J. Hardin who served in both Iraq and Afghanistan. Hardin tried all available methods of treating PTSD.
Colorectal cancer rates amongst adults under the age of 50 are on the rise, according to a recent study. Cases of colon and rectal cancer are on the rise in people under 50, according to the recent study, which showed that rates increased by more than 11 percent between 2004 and 2014. African-Americans are about twice as likely as whites to be diagnosed before the age of 50.
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