FDA Calendar

Date PDUFA table FDA is very important, because they help you to watch when decisions on main areas will be announced. In addition, as a rule, such reviews make it possible to anticipate key events and their development. Thus, the presence of prior knowledge of the catalyst provides a way to maximize profits or minimize losses trading in the stock of biotechnology companies.
Date Company Event Description Result
ADMA Biologics BLA FILING RI-002, immune deficiency diseases Success
Aerie Pharmaceuticals Phase 3 Rhopressa, Glaucoma & ocular hypertension Success
Akebia Therapeutics Phase 2 Vadadustat, Anemia related to chronic kidney disease Success
Amicus Therapeutics NDA FILING MIGALASTAT, Fabry disease Failure
Apricus Biosciences PHASE 2A RAYVA, secondary Raynaud's phenomenon Success
Flexion Therapeutics PHASE 2B FX006, osteoarthritis Failure
Genocea Biosciences PHASE 2 GEN-004, universal vaccine agains pneumococcus Failure
GW Pharmaceuticals PHASE 2 GWP42003, Schizophrenia Success
Heat Biologics PHASE 2 HS-110, cell lung Success
Heron Therapeutics PHASE 2 HTX-011, post-operative pain Success
Lipocine NDA FILING LPCN 1021, low testosteron Success
Neurocrine Biosciences PHASE 3 VMAT2 NBI-98854 - KINECT 3, tardive dyskinesia Success
Protalix BioTherapeutics PHASE 1/2 PRX-102, Fabry disease Success
PTC Therapeutics PHASE 3 ATALUREN, Duchenne muscular dystrophy Success
Puma Biotechnology PHASE 2 PB272, breast cancer Success
Radius Health NDA FILING ABALOPARATIDE-SC, osteoporosis Success
Raptor Pharmaceuticals PHASE 2 RP-103, fatty liver disease Failure
Sangamo Biosciences PHASE 2 SB-728-1401, HIV/AIDS Success
Spark Therapeutics PHASE 3 SPK-RPE65, inherited retinal dystrohies Success
Synthetic Biologics PHASE 2 SYN-004 (C-IBS) Failure
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