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
Genocea Biosciences PHASE 2 GEN-004, universal vaccine agains pneumococcus Failure
Protalix BioTherapeutics PHASE 1/2 PRX-102, Fabry disease Success
PTC Therapeutics PHASE 3 ATALUREN, Duchenne muscular dystrophy Success
Lipocine NDA FILING LPCN 1021, low testosteron Success
Radius Health NDA FILING ABALOPARATIDE-SC, osteoporosis Success
Neurocrine Biosciences PHASE 3 VMAT2 NBI-98854 - KINECT 3, tardive dyskinesia Success
Spark Therapeutics PHASE 3 SPK-RPE65, inherited retinal dystrohies Success
Amicus Therapeutics NDA FILING MIGALASTAT, Fabry disease Failure
Synthetic Biologics PHASE 2 SYN-004 (C-IBS) Failure
Verastem Phase 2 VS-6063, Pleural mesothelioma Failure
Puma Biotechnology PHASE 2 PB272, breast cancer Success
Heron Therapeutics PHASE 2 HTX-011, post-operative pain Success
ADMA Biologics BLA FILING RI-002, immune deficiency diseases Success
Heat Biologics PHASE 2 HS-110, cell lung Success
TRACON Pharmaceuticals PHASE 2 TRC105, hepatocelluar carcinoma Success
Aerie Pharmaceuticals Phase 3 Rhopressa, Glaucoma & ocular hypertension Success
Apricus Biosciences PHASE 2A RAYVA, secondary Raynaud's phenomenon Success
GW Pharmaceuticals PHASE 2 GWP42003, Schizophrenia Success
Raptor Pharmaceuticals PHASE 2 RP-103, fatty liver disease Failure
Sangamo Biosciences PHASE 2 SB-728-1401, HIV/AIDS Success
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