PDUFA Dates

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

39 UpcomingView Full Calendar

August 20268

4mo

REGNPDUFA$113.8B

Phase 3

FDA PDUFA Date Garetosmab (priority review)

Garetosmab• Fibrodysplasia Ossificans Progressiva

Aug 20AI-detected

Source

00%

4mo

CBDYPDUFA$5M

NDA

FDA PDUFA Date

Aug 24AI-detected

Source

00%

4mo

ESALYPDUFA

NDA

FDA PDUFA Date

Aug 24AI-detected

Source

00%

4mo

BIIBPDUFA$33.7B

NDA

FDA PDUFA Date

Aug 24AI-detected

Source

00%

4mo

JNJPDUFA$352.0B

NDA

FDA PDUFA Date Ziihera

Ziihera• GEA

Aug 25AI-detected

Source

00%

4mo

RHHBYPDUFA$331.8B

Phase 2

FDA PDUFA Date Iberdomide (priority review)

Iberdomide• Multiple Myeloma

Aug 25AI-detected

Source

00%

4mo

DRUGPDUFA$897M

NDA

FDA PDUFA Date zanidatamab (priority review)

Aug 25AI-detected

Source

00%

4mo

JAZZPDUFA$6.3B

NDA

FDA PDUFA Date zanidatamab (priority review)

Aug 25AI-detected

Source

00%

September 20264

4mo

CFOOPDUFA$864K

NDA

FDA PDUFA Date Zurletrectinib (priority review)

Zurletrectinib• pediatric solid tumors

Sep 2AI-detected

Source

00%

4mo

TAKPDUFA$48.3B

NDA

FDA PDUFA Date Rusfertide (priority review)

Rusfertide• Polycythemia Vera

Sep 2AI-detected

Source

00%

5mo

NUVLPDUFA$2.6B

NDA

FDA PDUFA Date zidesamtinib

Sep 18AI-detected

Source

00%

5mo

CBDYPDUFA$5M

NDA

FDA PDUFA Date Lirafugratinib (priority review)

Sep 27AI-detected

Source

00%

October 20263

5mo

RAREPDUFA$3.7B

Phase 3

FDA PDUFA Date UX111 (standard review)

UX111• MPS IIIA

Oct 7AI-detected

Source

00%

6mo

MRKPDUFA$245.9B

Phase 2

FDA PDUFA Date tildrakizumab

tildrakizumab• Psoriasis

Oct 29AI-detected

Source

00%

6mo

GILDPDUFA$60.0B

Phase 3

FDA PDUFA Date bictegravir 75 mg/lenacapavir 50 mg (priority review)

Lenacapavir• HIV Prevention

BTDFT

Oct 29AI-detected

Source

00%

November 20261

6mo

SMMTPDUFA$13.0B

Phase 3

FDA PDUFA Date ivonescimab

Drug: Ivonescimab Injection• Metastatic Colorectal Cancer (CRC)

Nov 1AI-detected

Source

00%

December 20269

7mo

MRKPDUFA$245.9B

Phase 3

FDA PDUFA Date - Zanzalintinib

Zanzalintinib• Renal Cell Carcinoma

Dec 1AI-detected

Source

00%

7mo

ACLXPDUFA$2.6B

NDA

FDA PDUFA Date

Dec 1AI-detected

Source

00%

8mo

RHHBYPDUFA$331.8B

NDA

FDA PDUFA Date

Dec 18AI-detected

Source

00%

8mo

ADVBPDUFA$4M

NDA

FDA PDUFA Date

Dec 18AI-detected

Source

00%

8mo

MLYSPDUFA$2.2B

Phase 3

FDA PDUFA Date lorundrostat

Lorundrostat• Obstructive Sleep Apnea

Dec 22AI-detected

Source

00%

8mo

GILDPDUFA$60.0B

Phase 3

FDA PDUFA Date bictegravir 75 mg/lenacapavir 50 mg (priority review)

Lenacapavir• HIV Prevention

BTDFT

Dec 25AI-detected

Source

00%

8mo

HMDCFPDUFA$2.5B

NDA

FDA PDUFA Date Sovleplenib (priority review)

Sovleplenib• Warm Antibody Autoimmune Hemolytic Anemia

Dec 25AI-detected

Source

00%

8mo

CNTAPDUFA$3.7B

NDA

FDA PDUFA Date epilepsy drug

epilepsy drug• epilepsy

Dec 27Confirmed

Source

00%

8mo

IDIAPDUFA

NDA

FDA PDUFA Date BOND-003

BOND-003

Dec 27AI-detected

Source

00%

January 20273

8mo

TAKPDUFA$48.3B

NDA

FDA PDUFA Date Potential Polycythemia Vera Treatment (standard review)

Potential Polycythemia Vera Treatment• Polycythemia Vera

Jan 1AI-detected

Source

00%

8mo

NUVBPDUFA$522.7B

NDA

FDA PDUFA Date taletrectinib

Jan 4AI-detected

Source

00%

9mo

VNDAPDUFA$489M

Phase 2

FDA PDUFA Date Imsidolimab (standard review)

Imsidolimab• Acne Vulgaris

Jan 28AI-detected

Source

00%

February 20275

10mo

CELG-RIPDUFA

Phase 3

FDA PDUFA Date iberdomide

Iberdomide• Multiple Myeloma

Feb 12AI-detected

Source

00%

10mo

OCULPDUFA$1.1B

NDA

FDA PDUFA Date AXPAXLI

AXPAXLI• wet-AMD

Feb 12AI-detected

Source

00%

10mo

DCPHPDUFA

NDA

FDA PDUFA Date Tirabrutinib

Tirabrutinib• relapsed or refractory PCNSL

Feb 12AI-detected

Source

00%

10mo

HRMYPDUFA$904M

NDA

FDA PDUFA Date

Feb 15AI-detected

Source

00%

10mo

MLTXPDUFA$1.1B

NDA

FDA PDUFA Date

• inflammatory arthritis

Feb 17AI-detected

Source

00%

March 20271

10mo

XENEPDUFA$2.9B

Phase 3

FDA PDUFA Date azetukalner (standard review)

Azetukalner• Major Depressive Disorder

Mar 4AI-detected

Source

00%

April 20272

11mo

CFOOPDUFA$864K

NDA

FDA PDUFA Date Trastuzumab Pamirtecan (T-Pam, DB-1303, BNT323)

Trastuzumab Pamirtecan (T-Pam, DB-1303, BNT323)• Unresectable or Metastatic HER2-Positive Adult Breast Cancer

Apr 4AI-detected

Source

00%

12mo

NHPAPPDUFA

NDA

FDA PDUFA Date MAIWEIJIAN (Denosumab)

MAIWEIJIAN (Denosumab)

Apr 10AI-detected

Source

00%

May 20273

12mo

NHPAPPDUFA

NDA

FDA PDUFA Date CXG87

CXG87• respiratory disease

May 2AI-detected

Source

00%

12mo

SKBBYPDUFA

Phase 2

FDA PDUFA Date Sacituzumab Tirumotecan (sac-TMT)

Sacituzumab Tirumotecan• Non-Small Cell Lung Cancer

May 3AI-detected

Source

00%

12mo

RGNXPDUFA$536M

NDA

FDA PDUFA Date Regenxbio gene therapy (unnamed)

Regenxbio gene therapy (unnamed)• Duchenne muscular dystrophy

May 9AI-detected

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.