Drug |
Stage |
Catalyst |
Market Cap |
AQST – Aquestive Therapeutics Inc.
Libervant - AQST-203
Epileptic seizures
|
PDUFA |
PDUFA date September 27, 2020. |
$176.6 million |
BHC – Bausch Health Companies Inc.,
ETON – Eton Pharmaceuticals Inc.
EM-100
Allergic conjunctivitis
|
PDUFA |
CRL issued July 12, 2019. NDA resubmitted with new PDUFA date of August 10, 2020. |
$6.5 billion |
BMRN – BioMarin Pharmaceutical Inc.
Valoctocogene roxaparvovec (BMN 270)
Hemophilia A
|
PDUFA priority review |
PDUFA date under priority review August 21, 2020. |
$21.7 billion |
DBVT – DBV Technologies S.A.
Viaskin Peanut
Peanut allergy - ages 4 to 11 years
|
PDUFA |
PDUFA date August 5, 2020 (likely to be extended). Advisory Committee meeting slated for May 15, 2020 has been cancelled. |
$451.1 million |
EGRX – Eagle Pharmaceuticals Inc.
Ryanodex
Exertional heat stroke (EHS)
|
PDUFA |
PDUFA date July 8, 2020 postponed until August 8, 2020 by FDA due to reallocation of resources as a result of COVID19. |
$634.9 million |
FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss
|
PDUFA priority review |
PDUFA date under priority review August 10, 2020. |
$214.1 million |
GLPG – Galapagos NV,
GILD – Gilead Sciences Inc.
Filgotinib
Rheumatoid arthritis (RA)
|
PDUFA |
NDA filing announced December 19, 2019. PDUFA estimate under priority review August 19, 2020. |
$12 billion |
LPCN – Lipocine Inc.
TLANDO - LPCN 1021
Men with low testosterone (Low T)
|
PDUFA |
PDUFA date August 28, 2020 |
$73.7 million |
MESO – Mesoblast Limited
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children
|
PDUFA priority review |
PDUFA
date under priority review September 30, 2020. FDA Oncologic Drugs
Advisory Committee meeting scheduled for August 13, 2020. |
$1.6 billion |
MNK – Mallinckrodt plc
Terlipressin
Hepatorenal syndrome (HRS) Type 1
|
PDUFA |
PDUFA date September 12, 2020. Advisory Committee Meeting July 15, 2020 voted 8-7 that the benefits outweigh the risks. |
$188.3 million |
PTCT – PTC Therapeutics Inc.,
RHHBY – Roche Holding Ltd ADR (Sponsored)
Risdiplam (RG7916)
Spinal Muscular Atrophy (SMA) Type 1
|
PDUFA priority review |
PDUFA date extended to August 24, 2020. |
$3 billion |
TCDA – Tricida Inc.
TRC 101
Chronic kidney disease
|
PDUFA |
PDUFA
date August 22, 2020. Company noted July 15, 2020 that the FDA has
identified deficiencies that preclude discussion of labeling and
postmarketing requirements/commitments. |
$668.4 million |
TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain
| PDUFA | PDUFA date August 7, 2020. |