| PDUFA Date | Days | Ticker | Company / Drug | Indication | Type | Market Cap | Price | Status |
|---|---|---|---|---|---|---|---|---|
| 2026-09-21 | 161d | MRK |
Merck & Co., Inc.
WINREVAIR
SEC filing ↗
|
PAH (Group 1 pulmonary hypertension) in adult patients with
|
sNDA/sBLA | $300.2B |
$121.42
-1.3% |
Pending |
| 2026-05-24 | 41d | BIIB |
BIOGEN INC.
SPINRAZA
SEC filing ↗
|
—
|
NDA/BLA | $25.4B |
$172.97
-2.3% |
Pending |
| 2026-06-01 | 49d | CYTK |
CYTOKINETICS INC
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $8.0B |
$65.01
+1.3% |
Pending |
| 2026-07-11 | 89d | CORT |
CORCEPT THERAPEUTICS INC
PDUFA
SEC filing ↗
|
—
|
NDA | $4.5B |
$41.91
-2.7% |
Pending |
| 2026-07-07 | 85d | VERA |
Vera Therapeutics, Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $3.2B |
$45.04
+9.6% |
Pending |
| 2026-06-01 | 49d | RARE |
Ultragenyx Pharmaceutical Inc.
PDUFA
SEC filing ↗
|
—
|
BLA | $2.3B |
$23.30
-2.5% |
Pending |
| 2026-06-01 | 49d | RARE |
Ultragenyx Pharmaceutical Inc.
Priority Review
SEC filing ↗
|
Sanfilippo syndrome type A
|
BLA | $2.3B |
$23.30
-2.5% |
Pending |
| 2026-06-01 | 49d | RARE |
Ultragenyx Pharmaceutical Inc.
DTX401
SEC filing ↗
|
glycogen storage disease type Ia (GSDIa): Biologics License
|
BLA | $2.3B |
$23.30
-2.5% |
Pending |
| 2027-03-01 | 322d | HRMY |
Harmony Biosciences Holdings, Inc.
WAKIX
SEC filing ↗
|
—
|
NDA/BLA | $1.7B |
$28.89
-1.1% |
Pending |
| 2027-03-01 | 322d | HRMY |
Harmony Biosciences Holdings, Inc.
SUBMISSION
SEC filing ↗
|
—
|
NDA | $1.7B |
$28.89
-1.1% |
Pending |
| 2028-06-01 | 780d | HRMY |
Harmony Biosciences Holdings, Inc.
EXTEND
SEC filing ↗
|
central disorders of hypersomnolence PROGRAMS TO PURSUE A DI
|
NDA/BLA | $1.7B |
$28.89
-1.1% |
Pending |
| 2028-06-01 | 780d | HRMY |
Harmony Biosciences Holdings, Inc.
ENHANCED
SEC filing ↗
|
central disorders of hypersomnolence PROGRAMS TO PURSUE A DI
|
NDA/BLA | $1.7B |
$28.89
-1.1% |
Pending |
| 2026-05-29 | 46d | MNKD |
MANNKIND CORP
EX-99
SEC filing ↗
|
—
|
NDA/BLA | $793.6M |
$2.57
-2.5% |
Pending |
| 2026-05-29 | 46d | MNKD |
MANNKIND CORP
Afrezza
SEC filing ↗
|
—
|
sNDA/sBLA | $793.6M |
$2.57
-2.5% |
Pending |
| 2026-10-17 | 187d | IRD |
Opus Genetics, Inc.
CNGB1
SEC filing ↗
|
presbyopia and set a PDUFA action date of October 17
|
sNDA/sBLA | $381.4M |
$5.36
-2.5% |
Pending |
| 2026-06-01 | 49d | RCKT |
ROCKET PHARMACEUTICALS, INC.
EX-99
SEC filing ↗
|
—
|
NDA/BLA | $378.9M |
$3.49
-1.7% |
Pending |
| 2026-06-01 | 49d | UNCY |
Unicycive Therapeutics, Inc.
PDUFA
SEC filing ↗
|
—
|
NDA | $167.3M |
$6.63
-0.3% |
Pending |
| 2026-06-18 | 66d | SPRO |
Spero Therapeutics, Inc.
EX-99
SEC filing ↗
|
—
|
NDA | $154.6M |
$2.67
-4.6% |
Pending |
| 2026-06-18 | 66d | SPRO |
Spero Therapeutics, Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $154.6M |
$2.67
-4.6% |
Pending |
| 2026-10-30 | 200d | INO |
INOVIO PHARMACEUTICALS, INC.
INO-3107
SEC filing ↗
|
—
|
BLA | $86.5M |
$1.06
-0.9% |
Pending |
| 2026-06-01 | 49d | INO |
INOVIO PHARMACEUTICALS, INC.
EX-99
SEC filing ↗
|
—
|
BLA | $86.5M |
$1.06
-0.9% |
Pending |
| 2026-06-01 | 49d | CLNN |
Clene Inc.
PDUFA
SEC filing ↗
|
—
|
NDA | $72.0M |
$6.11
-5.4% |
Pending |
| 2026-05-31 | 48d | CING |
Cingulate Inc.
Accepted
SEC filing ↗
|
—
|
NDA | $67.0M |
$5.76
-3.4% |
Pending |
| 2026-05-31 | 48d | CING |
Cingulate Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $67.0M |
$5.76
-3.4% |
Pending |
| 2026-06-01 | 49d | BFRI |
Biofrontera Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $12.0M | $1.03 | Pending |