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
21.09.2015
ADMA Biologics
BLA FILING
RI-002, immune deficiency diseases
Success
17.09.2015
Aerie Pharmaceuticals
Phase 3
Rhopressa, Glaucoma & ocular hypertension
Success
09.09.2015
Akebia Therapeutics
Phase 2
Vadadustat, Anemia related to chronic kidney disease
Success
02.10.2015
Amicus Therapeutics
NDA FILING
MIGALASTAT, Fabry disease
Failure
17.09.2015
Apricus Biosciences
PHASE 2A
RAYVA, secondary Raynaud's phenomenon
Success
09.09.2015
Flexion Therapeutics
PHASE 2B
FX006, osteoarthritis
Failure
19.10.2015
Genocea Biosciences
PHASE 2
GEN-004, universal vaccine agains pneumococcus
Failure
15.09.2015
GW Pharmaceuticals
PHASE 2
GWP42003, Schizophrenia
Success
18.09.2015
Heat Biologics
PHASE 2
HS-110, cell lung
Success
23.09.2015
Heron Therapeutics
PHASE 2
HTX-011, post-operative pain
Success
15.10.2015
Lipocine
NDA FILING
LPCN 1021, low testosteron
Success
08.10.2015
Neurocrine Biosciences
PHASE 3
VMAT2 NBI-98854 - KINECT 3, tardive dyskinesia
Success
19.10.2015
Protalix BioTherapeutics
PHASE 1/2
PRX-102, Fabry disease
Success
16.10.2015
PTC Therapeutics
PHASE 3
ATALUREN, Duchenne muscular dystrophy
Success
26.09.2015
Puma Biotechnology
PHASE 2
PB272, breast cancer
Success
12.10.2015
Radius Health
NDA FILING
ABALOPARATIDE-SC, osteoporosis
Success
14.09.2015
Raptor Pharmaceuticals
PHASE 2
RP-103, fatty liver disease
Failure
10.09.2015
Sangamo Biosciences
PHASE 2
SB-728-1401, HIV/AIDS
Success
05.10.2015
Spark Therapeutics
PHASE 3
SPK-RPE65, inherited retinal dystrohies
Success
28.09.2015
Synthetic Biologics
PHASE 2
SYN-004 (C-IBS)
Failure