| PDUFA Date | Days | Ticker | Company / Drug | Indication | Type | Market Cap | Price | Status |
|---|---|---|---|---|---|---|---|---|
| 2026-09-21 | 157d | MRK |
Merck & Co., Inc.
WINREVAIR
SEC filing ↗
|
PAH (Group 1 pulmonary hypertension) in adult patients with
|
sNDA/sBLA | $292.1B |
$118.15
-1.8% |
Pending |
| 2026-05-24 | 37d | BIIB |
BIOGEN INC.
SPINRAZA
SEC filing ↗
|
—
|
NDA/BLA | $26.3B |
$179.47
+0.1% |
Pending |
| 2026-06-01 | 45d | CYTK |
CYTOKINETICS INC
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $8.0B |
$65.26
-1.9% |
Pending |
| 2026-07-11 | 85d | CORT |
CORCEPT THERAPEUTICS INC
PDUFA
SEC filing ↗
|
—
|
NDA | $4.7B |
$43.78
+0.1% |
Pending |
| 2026-07-07 | 81d | VERA |
Vera Therapeutics, Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $3.1B |
$42.82
-2.5% |
Pending |
| 2026-06-01 | 45d | RARE |
Ultragenyx Pharmaceutical Inc.
PDUFA
SEC filing ↗
|
—
|
BLA | $2.5B |
$25.27
+3.0% |
Pending |
| 2026-06-01 | 45d | RARE |
Ultragenyx Pharmaceutical Inc.
Priority Review
SEC filing ↗
|
Sanfilippo syndrome type A
|
BLA | $2.5B |
$25.27
+3.0% |
Pending |
| 2026-06-01 | 45d | RARE |
Ultragenyx Pharmaceutical Inc.
DTX401
SEC filing ↗
|
glycogen storage disease type Ia (GSDIa): Biologics License
|
BLA | $2.5B |
$25.27
+3.0% |
Pending |
| 2027-03-01 | 318d | HRMY |
Harmony Biosciences Holdings, Inc.
WAKIX
SEC filing ↗
|
—
|
NDA/BLA | $1.7B |
$29.32
+2.1% |
Pending |
| 2027-03-01 | 318d | HRMY |
Harmony Biosciences Holdings, Inc.
SUBMISSION
SEC filing ↗
|
—
|
NDA | $1.7B |
$29.32
+2.1% |
Pending |
| 2028-06-01 | 776d | HRMY |
Harmony Biosciences Holdings, Inc.
EXTEND
SEC filing ↗
|
central disorders of hypersomnolence PROGRAMS TO PURSUE A DI
|
NDA/BLA | $1.7B |
$29.32
+2.1% |
Pending |
| 2028-06-01 | 776d | HRMY |
Harmony Biosciences Holdings, Inc.
ENHANCED
SEC filing ↗
|
central disorders of hypersomnolence PROGRAMS TO PURSUE A DI
|
NDA/BLA | $1.7B |
$29.32
+2.1% |
Pending |
| 2026-05-29 | 42d | MNKD |
MANNKIND CORP
EX-99
SEC filing ↗
|
—
|
NDA/BLA | $838.4M |
$2.71
-1.1% |
Pending |
| 2026-05-29 | 42d | MNKD |
MANNKIND CORP
Afrezza
SEC filing ↗
|
—
|
sNDA/sBLA | $838.4M |
$2.71
-1.1% |
Pending |
| 2026-06-01 | 45d | RCKT |
ROCKET PHARMACEUTICALS, INC.
EX-99
SEC filing ↗
|
—
|
NDA/BLA | $414.1M |
$3.80
+3.3% |
Pending |
| 2026-10-17 | 183d | IRD |
Opus Genetics, Inc.
CNGB1
SEC filing ↗
|
presbyopia and set a PDUFA action date of October 17
|
sNDA/sBLA | $400.2M |
$5.62
+0.5% |
Pending |
| 2026-06-01 | 45d | UNCY |
Unicycive Therapeutics, Inc.
PDUFA
SEC filing ↗
|
—
|
NDA | $175.3M |
$6.95
+0.6% |
Pending |
| 2026-06-18 | 62d | SPRO |
Spero Therapeutics, Inc.
EX-99
SEC filing ↗
|
—
|
NDA | $154.0M |
$2.66
-4.3% |
Pending |
| 2026-06-18 | 62d | SPRO |
Spero Therapeutics, Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $154.0M |
$2.66
-4.3% |
Pending |
| 2026-10-30 | 196d | INO |
INOVIO PHARMACEUTICALS, INC.
INO-3107
SEC filing ↗
|
—
|
BLA | $95.5M |
$1.17
+5.4% |
Pending |
| 2026-06-01 | 45d | INO |
INOVIO PHARMACEUTICALS, INC.
EX-99
SEC filing ↗
|
—
|
BLA | $95.5M |
$1.17
+5.4% |
Pending |
| 2026-06-01 | 45d | CLNN |
Clene Inc.
PDUFA
SEC filing ↗
|
—
|
NDA | $75.3M |
$6.39
-3.3% |
Pending |
| 2026-05-31 | 44d | CING |
Cingulate Inc.
Accepted
SEC filing ↗
|
—
|
NDA | $61.1M |
$5.25
-3.6% |
Pending |
| 2026-05-31 | 44d | CING |
Cingulate Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $61.1M |
$5.25
-3.6% |
Pending |
| 2026-06-01 | 45d | BFRI |
Biofrontera Inc.
PDUFA
SEC filing ↗
|
—
|
NDA/BLA | $12.5M |
$1.07
-0.9% |
Pending |