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
01.09.2015
Trevena
Phase 2b
TRV-130, Painkiller
Success
09.09.2015
Flexion Therapeutics
PHASE 2B
FX006, osteoarthritis
Failure
09.09.2015
Akebia Therapeutics
Phase 2
Vadadustat, Anemia related to chronic kidney disease
Success
09.09.2015
Tetraphase Pharmaceuticals
Phase 3
Eravacycline, Complicated urinary tract infections
Failure
10.09.2015
Sangamo Biosciences
PHASE 2
SB-728-1401, HIV/AIDS
Success
14.09.2015
Raptor Pharmaceuticals
PHASE 2
RP-103, fatty liver disease
Failure
15.09.2015
GW Pharmaceuticals
PHASE 2
GWP42003, Schizophrenia
Success
17.09.2015
Apricus Biosciences
PHASE 2A
RAYVA, secondary Raynaud's phenomenon
Success
17.09.2015
Aerie Pharmaceuticals
Phase 3
Rhopressa, Glaucoma & ocular hypertension
Success
18.09.2015
Heat Biologics
PHASE 2
HS-110, cell lung
Success
18.09.2015
TRACON Pharmaceuticals
PHASE 2
TRC105, hepatocelluar carcinoma
Success
21.09.2015
ADMA Biologics
BLA FILING
RI-002, immune deficiency diseases
Success
23.09.2015
Heron Therapeutics
PHASE 2
HTX-011, post-operative pain
Success
26.09.2015
Puma Biotechnology
PHASE 2
PB272, breast cancer
Success
28.09.2015
Synthetic Biologics
PHASE 2
SYN-004 (C-IBS)
Failure
28.09.2015
Verastem
Phase 2
VS-6063, Pleural mesothelioma
Failure
02.10.2015
Amicus Therapeutics
NDA FILING
MIGALASTAT, Fabry disease
Failure
05.10.2015
Spark Therapeutics
PHASE 3
SPK-RPE65, inherited retinal dystrohies
Success
08.10.2015
Neurocrine Biosciences
PHASE 3
VMAT2 NBI-98854 - KINECT 3, tardive dyskinesia
Success
12.10.2015
Radius Health
NDA FILING
ABALOPARATIDE-SC, osteoporosis
Success