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FDA Calendar

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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
Ticker
Drug
Event
Date
Outcome
Details
Puma Biotechnology Inc.
PB272 (Neratinib) (NDA)
FDA decision on PB272 for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer
07/21/2017
Amgen Inc.
Romosozumab (BLA)
FDA decision on Romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture
07/19/2017
Tesaro Inc.
Niraparib (NDA)
FDA decision on Niraparib a treatment for patients with recurrent epithelial ovarian for treatment of fallopian tube, or primary peritoneal cancer
06/30/2017
Array BioPharma Inc.
Binimetinib (NDA)
FDA decision on Binimetinib for patients with NRAS-mutant melanoma.
06/30/2017
Portola Pharmaceuticals Inc.
Betrixaban (NDA)
FDA decision on Betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
06/24/2017
Neos Therapeutics, Inc.
Cotempla XR-ODT (NDA resubmission)
FDA decision on Cotempla XR-ODT for the treatment of ADHD
06/20/2017
Shire plc
SHPG, SHP.L
SHP465 (NDA resubmission)
FDA decision on SHP465 for treatment of ADHD
06/20/2017
Genmab A/S
GMXAY.PK, GNMSF.OB
DARZALEX in combination with pomalidomide and dexamethasone (sBLA)
FDA decision on DARZALEX combination for relapsed or refractory multiple myeloma
06/17/2017
Coherus Biosciences, Inc.
CHS-1701 (351(k) BLA)
FDA decision on CHS-1701, a biosimilar to Neulasta
06/09/2017
TherapeuticsMD
Yuvvexy (NDA)
FDA decision on Yuvvexy for the treatment of moderate-to-severe vaginal pain during sexual intercourse
05/07/2017
Novartis AG
LEE011 (NDA)
FDA decision on LEE011 for first-line treatment of HR+/HER2- advanced breast cancer
05/01/2017
Roche Holding AG
TECENTRIQ (sBLA)
FDA decision on TECENTRIQ for locally advanced or metastatic urothelial carcinoma patients who are ineligible for cisplatin chemotherapy
04/30/2017
Ariad Pharmaceuticals Inc
Brigatinib (NDA)
FDA decision on Brigatinib for metastatic ALK-positive non-small cell lung cancer
04/29/2017
Biomarin Pharmaceutical Inc.
Brineura (BLA)
FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
04/27/2017
Eli Lilly And Co.
Baricitinib (NDA)
FDA decision on Baricitinib for the treatment of rheumatoid arthritis
04/19/2017
Pulsebioscience-021717.jpg Shares of development-stage medical technology company Pulse Biosciences Inc. (PLSE) have gained nearly 30% so far this week.
pharma-021617.jpg Ardelyx Inc.'s (ARDX) phase III clinical trial of Tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis has met its primary endpoint and was generally well-tolerated.
pharma-021517.jpg Axsome Therapeutics Inc.'s (AXSM) drug candidate AXS-05 has received Fast Track status from the FDA for treatment resistant depression.
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