PDUFA Dates

FDA target action dates for drug approval decisions. Track all upcoming PDUFA dates for biotech stocks.

78 UpcomingView Full Calendar

February 20269

Tomorrow

RGNX🎯PDUFA$536M

FDA PDUFA Date RGX-121 (priority review)

Feb 8

Source

00%

days

FBIOP🎯PDUFA$64M

FDA PDUFA Date CUTX-101 (standard)

Feb 9

SEC

00%

days

AQST🎯PDUFA$207M

FDA PDUFA Date AQST-109 (standard)

Feb 10

SEC

00%

JAZZ🎯PDUFA$6.4B

FDA PDUFA Date JZP-458 (priority)

Feb 12

SEC

00%

ALDX🎯PDUFA$192M

FDA PDUFA Date reproxalap (standard)

Feb 17

SEC

00%

CORT🎯PDUFA$2.7B

FDA PDUFA Date CORT125134 (standard)

Feb 18

SEC

00%

ASND🎯PDUFA$13.1B

FDA PDUFA Date TransCon hGH (standard)

Feb 25

SEC

00%

PGEN🎯PDUFA$240M

FDA PDUFA Date PRGN-3005 (priority)

Feb 26

SEC

00%

CRNX🎯PDUFA$3.5B

FDA PDUFA Date paltusotine (standard)

Feb 28

SEC

00%

March 20269

OTLK🎯PDUFA$27M

FDA PDUFA Date ONS-5010 / LYTENAVA (standard)

Mar 1

SEC

00%

SAN.PA🎯PDUFA$98.9B

FDA PDUFA Date Efanesoctocog alfa (priority)

Mar 1

SEC

00%

2mo

ALDX🎯PDUFA$192M

FDA PDUFA Date reproxalap (standard)

Mar 17

SEC

00%

2mo

TVTX🎯PDUFA$624M

FDA PDUFA Date sparsentan (priority)

Mar 18

SEC

00%

2mo

OTLK🎯PDUFA$27M

FDA PDUFA Date ONS-5010 (standard)

Mar 23

SEC

00%

2mo

ATHA🎯PDUFA$86M

FDA PDUFA Date ATH-1017 (standard)

Mar 25

SEC

00%

2mo

JAZZ🎯PDUFA$6.4B

FDA PDUFA Date (priority review)

Mar 28

Source

00%

2mo

LNTH🎯PDUFA$4.2B

FDA PDUFA Date LNTH-2501 (priority review)

Mar 29

Source

00%

2mo

LENZ🎯PDUFA$363M

FDA PDUFA Date LENZ-123 (standard)

Mar 31

SEC

00%

April 202611

2mo

REPL🎯PDUFA$523M

FDA PDUFA Date RP1 (priority)

Apr 1

SEC

00%

2mo

RCKTW🎯PDUFA

FDA PDUFA Date RP-L201 (priority)

Apr 2

SEC

00%

2mo

AXSM🎯PDUFA$3.2B

FDA PDUFA Date AXS-05 (standard)

Apr 3

SEC

00%

3mo

CORT🎯PDUFA$2.7B

FDA PDUFA Date CORT118335 (standard)

Apr 9

SEC

00%

3mo

ASND🎯PDUFA$13.1B

FDA PDUFA Date TransCon CNP (priority)

Apr 10

SEC

00%

3mo

AQST🎯PDUFA$207M

FDA PDUFA Date AQST-109 (standard)

Apr 11

SEC

00%

3mo

INO🎯PDUFA$208M

FDA PDUFA Date INO-4800 (priority)

Apr 20

SEC

00%

3mo

NRXPW🎯PDUFA

FDA PDUFA Date ZYESAMI (priority)

Apr 26

SEC

00%

3mo

AQST🎯PDUFA$207M

FDA PDUFA Date EXSERVAN (standard)

Apr 27

SEC

00%

3mo

INSM🎯PDUFA$11.0B

FDA PDUFA Date Arikayce (priority)

Apr 28

SEC

00%

3mo

CYTK🎯PDUFA$5.6B

FDA PDUFA Date omecamtiv mecarbil (standard)

Apr 30

SEC

00%

May 202616

3mo

CORT🎯PDUFA$2.7B

FDA PDUFA Date Relacorilant (standard)

May 1

SEC

00%

3mo

DNLI🎯PDUFA$1.9B

FDA PDUFA Date DNLI-7001 (priority)

May 1

SEC

00%

3mo

LNTH🎯PDUFA$4.2B

FDA PDUFA Date product name (priority)

May 6

SEC

00%

3mo

ATHA🎯PDUFA$86M

FDA PDUFA Date ATH-1017 (standard)

May 7

SEC

00%

4mo

ATRA🎯PDUFA$41M

FDA PDUFA Date ATA188 (priority)

May 9

SEC

00%

4mo

CORT🎯PDUFA$2.7B

FDA PDUFA Date Relacorilant (standard)

May 12

SEC

00%

4mo

RGNX🎯PDUFA$536M

FDA PDUFA Date RGX-314 (priority)

May 12

SEC

00%

4mo

AGIO🎯PDUFA$2.4B

FDA PDUFA Date Pyrukynd (standard)

May 12

SEC

00%

4mo

ACHV🎯PDUFA$144M

FDA PDUFA Date cytisinicline (standard)

May 15

SEC

00%

4mo

TVTX🎯PDUFA$624M

FDA PDUFA Date sparsentan (priority)

May 15

SEC

00%

4mo

HRMY🎯PDUFA$904M

FDA PDUFA Date WAKIX (standard)

May 19

SEC

00%

4mo

CRNX🎯PDUFA$3.5B

FDA PDUFA Date paltusotine (standard)

May 21

SEC

00%

4mo

RARE🎯PDUFA$3.7B

FDA PDUFA Date DTX401 (standard)

May 22

SEC

00%

4mo

CYTK🎯PDUFA$5.6B

FDA PDUFA Date reldesemtiv (standard)

May 24

SEC

00%

4mo

VNDA🎯PDUFA$320M

FDA PDUFA Date VP-VLY-686 (standard)

May 25

SEC

00%

4mo

TNXP🎯PDUFA$7M

FDA PDUFA Date TNX-1800 (priority)

May 31

SEC

00%

June 202616

4mo

DNLI🎯PDUFA$1.9B

FDA PDUFA Date DNL310 (standard)

Jun 1

SEC

00%

4mo

REPL🎯PDUFA$523M

FDA PDUFA Date

Jun 3

SEC

00%

4mo

AGIO🎯PDUFA$2.4B

FDA PDUFA Date Undisclosed drug candidate (standard)

Jun 6

SEC

00%

5mo

KURA🎯PDUFA$1.6B

FDA PDUFA Date tipifarnib (priority)

Jun 12

SEC

00%

5mo

PHAR🎯PDUFA$1.3B

FDA PDUFA Date leniolisib (priority)

Jun 15

SEC

00%

5mo

SAN.PA🎯PDUFA$98.9B

FDA PDUFA Date Fitusiran (priority)

Jun 16

SEC

00%

5mo

IMCR🎯PDUFA$1.6B

FDA PDUFA Date tebentafusp-tebn (priority)

Jun 18

SEC

00%

5mo

REPL🎯PDUFA$523M

FDA PDUFA Date lifileucel (priority)

Jun 19

SEC

00%

5mo

VNDA🎯PDUFA$320M

FDA PDUFA Date tradipitant (standard)

Jun 20

SEC

00%

5mo

ASND🎯PDUFA$13.1B

FDA PDUFA Date TransCon hGH (standard)

Jun 21

SEC

00%

5mo

CORT🎯PDUFA$2.7B

FDA PDUFA Date NDA for relacorilant (standard)

Jun 25

SEC

00%

5mo

TNXP🎯PDUFA$7M

FDA PDUFA Date TNX-102 SL (standard)

Jun 26

SEC

00%

5mo

LQDA🎯PDUFA$686M

FDA PDUFA Date LIQ861 (standard)

Jun 27

SEC

00%

5mo

SAN.PA🎯PDUFA$98.9B

FDA PDUFA Date Efanesoctocog alfa (priority)

Jun 29

SEC

00%

5mo

RYTM🎯PDUFA$7.4B

FDA PDUFA Date setmelanotide (priority)

Jun 30

SEC

00%

5mo

CRNX🎯PDUFA$3.5B

FDA PDUFA Date paltusotine (standard)

Jun 30

SEC

00%

July 20264

5mo

KURA🎯PDUFA$1.6B

FDA PDUFA Date Tipifarnib (priority)

Jul 1

SEC

00%

5mo

TVTX🎯PDUFA$624M

FDA PDUFA Date sparsentan (priority)

Jul 7

SEC

00%

5mo

DNLI🎯PDUFA$1.9B

FDA PDUFA Date NEDD4-L inhibitor DNL310 (priority)

Jul 7

SEC

00%

6mo

TVTX🎯PDUFA$624M

FDA PDUFA Date sparsentan (priority)

Jul 27

SEC

00%

August 20266

6mo

SAN.PA🎯PDUFA$98.9B

FDA PDUFA Date (standard)

Aug 1

SEC

00%

6mo

SNDX🎯PDUFA$1.7B

FDA PDUFA Date (standard)

Aug 5

SEC

00%

6mo

CAPR🎯PDUFA$140M

FDA PDUFA Date CAP-1002 (standard)

Aug 6

SEC

00%

7mo

SAN.PA🎯PDUFA$98.9B

FDA PDUFA Date (standard)

Aug 20

SEC

00%

7mo

ARGX🎯PDUFA$50.3B

FDA PDUFA Date efgartigimod alfa (priority)

Aug 20

SEC

00%

7mo

FBIOP🎯PDUFA$64M

FDA PDUFA Date IV Tramadol (standard)

Aug 26

SEC

00%

September 20263

8mo

TNXP🎯PDUFA$7M

FDA PDUFA Date TNX-102 SL (standard)

Sep 15

SEC

00%

8mo

MNKD🎯PDUFA$1.4B

FDA PDUFA Date MannKind's product (standard)

Sep 22

SEC

00%

8mo

TVTX🎯PDUFA$624M

FDA PDUFA Date undisclosed drug candidate (standard)

Sep 28

SEC

00%

October 20262

8mo

NUVB🎯PDUFA$522.7B

FDA PDUFA Date NUV-868 (priority)

Oct 1

SEC

00%

9mo

KURA🎯PDUFA$1.6B

FDA PDUFA Date ziftomenib (priority)

Oct 22

SEC

00%

November 20261

9mo

SMMT🎯PDUFA$13.0B

FDA PDUFA Date ivonescimab

Nov 1

Source

00%

December 20261

11mo

CNTA🎯PDUFA$3.7B

FDA PDUFA Date epilepsy drug

Dec 27

Source

00%

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About PDUFA Dates

FDA target action dates for drug approval decisions. Track all upcoming PDUFA dates for biotech stocks.

What is a PDUFA Date?

A PDUFA date is the deadline by which the FDA must make a decision on a drug application. These dates are set according to the Prescription Drug User Fee Act, which requires the FDA to complete reviews within specific timeframes. Standard reviews have a 10-month deadline, while priority reviews are completed in 6 months.

Why PDUFA Dates Matter

PDUFA dates are binary events that can cause significant stock price movements. An approval can send shares soaring, while a rejection, complete response letter (CRL), or delay can result in sharp declines. Investors track these dates closely to anticipate volatility.