Date |
Symbol |
Description |
Type |
Disease |
Designation |
Success Rating |
Q3 2016
|
TNXP |
|
Phase 3 Results |
Neurology |
Special Protocol Assessment |
|
05/01/2016
|
ACAD |
|
PDUFA |
Neurology |
Breakthrough Therapy, Priority Review |
|
03/29/2016
|
ACAD |
|
Advisory Panel |
Neurology |
Breakthrough Therapy, Priority Review |
|
H2 2018
|
MACK |
|
Phase 2 Results |
Oncology |
Orphan Drug |
|
04/15/2016
|
CHMA |
|
PDUFA |
Endocrine |
Orphan Drug |
|
Q3 2017
|
PBYI |
|
PDUFA |
Oncology |
None |
|
Q4 2016
|
ARIA |
|
Phase 2 Results |
Oncology |
None |
|
H2 2016
|
GWPH |
|
Phase 3 Results |
Neurology |
Fast Track, Orphan Drug |
|
04/25/2016
|
SRPT |
|
Advisory Panel |
Other |
Fast Track, Orphan Drug, Priority Review, Rare Pediatric Disease |
|
05/26/2016
|
SRPT |
|
PDUFA |
Other |
Fast Track, Orphan Drug, Priority Review, Rare Pediatric Disease |
|