PDUFA Dates

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

72 UpcomingView Full Calendar

June 20266

3mo

CORTPDUFA$2.7B

Phase 3

FDA PDUFA Date NDA for relacorilant (standard)

Relacorilant• Recurrent Ovarian Cancer

Jun 25Confirmed

SEC

00%

4mo

LQDAPDUFA$686M

Phase 3

FDA PDUFA Date LIQ861 (standard)

LIQ861 Inhaled Treprostinil• Primary Pulmonary Hypertension

Jun 27Confirmed

SEC

00%

4mo

MNKDPDUFA$1.4B

Phase 3

FDA PDUFA Date Afrezza (standard)

Afrezza• Diabetes Mellitus, Type 1

Jun 28Confirmed

SEC

00%

4mo

RAREPDUFA$3.7B

Phase 3

FDA PDUFA Date UX111 (standard)

UX111• MPS IIIA

Jun 29Confirmed

SEC

00%

4mo

GRCEPDUFA$73M

NDA

FDA PDUFA Date GRCE-175 (standard)

GRCE-175• diabetic kidney disease

Jun 30Confirmed

SEC

00%

4mo

ANABPDUFA$488M

NDA

FDA PDUFA Date

Jun 30Confirmed

SEC

00%

July 202611

4mo

SMMTPDUFA$13.0B

Phase 3

FDA PDUFA Date ridinilazole (priority)

Ridinilazole• Clostridioides Difficile Infection

Jul 1Confirmed

SEC

00%

4mo

CAPRPDUFA$1.3B

NDA

FDA PDUFA Date

Jul 1Confirmed

SEC

00%

4mo

VRDNPDUFA$732M

Phase 3

FDA PDUFA Date VRDN-001 (standard)

VRDN-003• Thyroid Eye Disease

Jul 2Confirmed

SEC

00%

4mo

DNLIPDUFA$1.9B

Phase 2

FDA PDUFA Date NEDD4-L inhibitor DNL310 (priority)

DNL126• Mucopolysaccharidosis Type IIIA

Jul 7Confirmed

SEC

00%

4mo

MLYSPDUFA$2.2B

NDA

FDA PDUFA Date MT-401 (standard)

MT-401• primary aldosteronism

Jul 15Confirmed

SEC

00%

4mo

VNDAPDUFA$489M

Phase 3

FDA PDUFA Date Tradipitant (standard)

Tradipitant• Motion Sickness

Jul 20Confirmed

SEC

00%

4mo

ACLXPDUFA$2.6B

NDA

FDA PDUFA Date CART-ddBCMA (priority)

CART-ddBCMA• relapsed or refractory multiple myeloma

Jul 20Confirmed

SEC

00%

4mo

CLNNPDUFA$65M

Phase 3

FDA PDUFA Date CNM-Au8 (priority)

CNM-Au8• Relapsing Multiple Sclerosis

Jul 21Confirmed

SEC

00%

5mo

AQSTPDUFA$499M

NDA

FDA PDUFA Date Libervant (standard)

Libervant• seizures

Jul 31Confirmed

SEC

00%

5mo

ZLABPDUFA$1.7B

Phase 3

FDA PDUFA Date Elzovantinib (priority)

Investigator's Choice of Therapy• Small-cell Lung Cancer

Jul 31Confirmed

SEC

00%

5mo

RCKTWPDUFA

Phase 2

FDA PDUFA Date RP-L102 (priority)

RP-L102• Fanconi Anemia Complementation Group A

Jul 31Confirmed

SEC

00%

August 202611

5mo

SNYPDUFA$115.3B

NDA

FDA PDUFA Date (standard)

Aug 1Confirmed

SEC

00%

5mo

CBDYPDUFA$1M

NDA

FDA PDUFA Date INO-3107 (accelerated review)

INO-3107• Recurrent Respiratory Papillomatosis (RRP)

Aug 1AI-detected

Source

00%

5mo

MRNAPDUFA$42.1B

Phase 3

FDA PDUFA Date - mRNA influenza vaccine

Influenza Vaccine• SARS-CoV-2

Aug 5AI-detected

Source

00%

5mo

SNDXPDUFA$1.7B

NDA

FDA PDUFA Date (standard)

Aug 5Confirmed

SEC

00%

5mo

ALDXPDUFA$111M

Phase 3

FDA PDUFA Date reproxalap (standard)

Reproxalap Ophthalmic Solution (0.5%)• Allergic Conjunctivitis

Aug 14Confirmed

SEC

00%

5mo

NRXPPDUFA$80M

NDA

FDA PDUFA Date NRX-101 (standard)

NRX-101• bipolar depression and suicidal ideation

Aug 17Confirmed

SEC

00%

5mo

REGNPDUFA$113.8B

Phase 3

FDA PDUFA Date Garetosmab (priority review)

Garetosmab• Fibrodysplasia Ossificans Progressiva

Aug 20AI-detected

Source

00%

5mo

ARGXPDUFA$50.3B

Phase 3

FDA PDUFA Date efgartigimod alfa (priority)

Efgartigimod IV• Generalized Myasthenia Gravis

Aug 20Confirmed

SEC

00%

5mo

RHHBYPDUFA$344.8B

Phase 2

FDA PDUFA Date Iberdomide (priority review)

Iberdomide• Multiple Myeloma

Aug 25AI-detected

Source

00%

6mo

FBIOPDUFA$247M

NDA

FDA PDUFA Date IV Tramadol (standard)

IV Tramadol

Aug 26Confirmed

SEC

00%

6mo

ASNDPDUFA$13.1B

Phase 3

FDA PDUFA Date TransCon hGH (priority)

TransCon hGH• Growth Hormone Deficiency, Pediatric

Aug 26Confirmed

SEC

00%

September 202612

6mo

TAKPDUFA$48.3B

NDA

FDA PDUFA Date Rusfertide (priority review)

Rusfertide• Polycythemia Vera

Sep 2AI-detected

Source

00%

6mo

CFOOPDUFA$13M

NDA

FDA PDUFA Date Zurletrectinib (priority review)

Zurletrectinib• pediatric solid tumors

Sep 2AI-detected

Source

00%

6mo

INOPDUFA$106M

Phase 2

FDA PDUFA Date INO-4800 (priority)

INO-4700• Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Sep 3Confirmed

SEC

00%

6mo

PURRPDUFA$532M

NDA

FDA PDUFA Date Hyperlaid (standard)

Hyperlaid• Obesity

Sep 4Confirmed

SEC

00%

6mo

CAPRPDUFA$1.3B

Phase 3

FDA PDUFA Date CAP-1002 (standard)

CAP-1002• Duchenne Muscular Dystrophy

FTOrphan

Sep 8Confirmed

SEC

00%

6mo

MLYSPDUFA$2.2B

NDA

FDA PDUFA Date (standard)

Sep 9Confirmed

SEC

00%

6mo

DSKYFPDUFA$41.1B

Phase 3

FDA PDUFA Date Enhertu (priority review)

Capecitabine• Breast Cancer

Sep 12AI-detected

Source

00%

6mo

TNXPPDUFA$201M

Phase 3

FDA PDUFA Date TNX-102 SL (standard)

TNX-102 SL• Primary Fibromyalgia

Sep 15Confirmed

SEC

00%

6mo

DSKYFPDUFA$41.1B

Phase 3

FDA PDUFA Date Candidate Breast Cancer Treatment (priority review)

Capecitabine• Breast Cancer

Sep 20AI-detected

Source

00%

6mo

MNKDPDUFA$1.4B

NDA

FDA PDUFA Date MannKind's product (standard)

MannKind's product• diabetes

Sep 22Confirmed

SEC

00%

7mo

NUVLPDUFA$2.6B

Phase 3

FDA PDUFA Date NUV-1034 (standard)

Neladalkib (NVL-655)• Non-small Cell Lung Cancer

Sep 26Confirmed

SEC

00%

7mo

TVTXPDUFA$624M

NDA

FDA PDUFA Date undisclosed drug candidate (standard)

undisclosed drug candidate• undisclosed

Sep 28Confirmed

SEC

00%

October 20266

7mo

NUVBPDUFA$522.7B

NDA

FDA PDUFA Date NUV-868 (priority)

NUV-868• prostate cancer

Oct 1Confirmed

SEC

00%

7mo

IONSPDUFA$5.7B

NDA

FDA PDUFA Date drug candidate (standard)

drug candidate• disease condition

Oct 1Confirmed

SEC

00%

7mo

GSKPDUFA$99.3B

NDA

FDA PDUFA Date Belumosudil (priority)

Belumosudil• chronic graft-versus-host disease

Oct 1Confirmed

SEC

00%

7mo

VERAPDUFA$1.7B

Phase 3

FDA PDUFA Date VTR-297 (standard)

Atacicept• IgA Nephropathy (IgAN)

Oct 6Confirmed

SEC

00%

7mo

KURAPDUFA$1.6B

Phase 3

FDA PDUFA Date ziftomenib (priority)

Ziftomenib• Acute Myeloid Leukemia (AML)

Oct 22Confirmed

SEC

00%

8mo

MRKPDUFA$245.9B

Phase 2

FDA PDUFA Date tildrakizumab

tildrakizumab• Psoriasis

Oct 29AI-detected

Source

00%

November 20264

8mo

SMMTPDUFA$13.0B

Phase 3

FDA PDUFA Date ivonescimab

Drug: Ivonescimab Injection• Metastatic Colorectal Cancer (CRC)

Nov 1AI-detected

Source

00%

8mo

TAKPDUFA$48.3B

Phase 3

FDA PDUFA Date TAK-721 (priority)

TAK-771• Primary Immunodeficiency Diseases (PID)

Nov 10Confirmed

SEC

00%

8mo

TLPPFPDUFA$2.6B

NDA

FDA PDUFA Date TLX250-CDx (standard)

TLX250-CDx• clear cell renal cell carcinoma

Nov 15Confirmed

SEC

00%

8mo

LGNDZPDUFA

NDA

FDA PDUFA Date LIGAND PHARMACEUTICALS INC (standard)

LIGAND PHARMACEUTICALS INC

Nov 23Confirmed

SEC

00%

December 20267

9mo

MRKPDUFA$245.9B

Phase 3

FDA PDUFA Date - Zanzalintinib

Zanzalintinib• Renal Cell Carcinoma

Dec 1AI-detected

Source

00%

9mo

ACLXPDUFA$2.6B

NDA

FDA PDUFA Date

Dec 1AI-detected

Source

00%

9mo

RHHBYPDUFA$344.8B

NDA

FDA PDUFA Date

Dec 18AI-detected

Source

00%

9mo

ADVBPDUFA$93M

NDA

FDA PDUFA Date

Dec 18AI-detected

Source

00%

10mo

AXSMPDUFA$3.2B

Phase 3

FDA PDUFA Date AXS-05 (standard)

AXS-05• Agitation in Patients With Dementia of the Alzheimer's Type

Dec 24Confirmed

SEC

00%

10mo

IDIAPDUFA

NDA

FDA PDUFA Date BOND-003

BOND-003

Dec 27AI-detected

Source

00%

10mo

CNTAPDUFA$3.7B

NDA

FDA PDUFA Date epilepsy drug

epilepsy drug• epilepsy

Dec 27Confirmed

Source

00%

January 20277

10mo

EXELPDUFA$4.8B

Phase 3

FDA PDUFA Date cabozantinib (priority)

Cabozantinib• Solid Tumors

Jan 1Confirmed

SEC

00%

10mo

TAKPDUFA$48.3B

NDA

FDA PDUFA Date Potential Polycythemia Vera Treatment (standard review)

Potential Polycythemia Vera Treatment• Polycythemia Vera

Jan 1AI-detected

Source

00%

10mo

ARGXPDUFA$50.3B

Phase 3

FDA PDUFA Date efgartigimod alfa-fcab (priority)

Efgartigimod• Postural Orthostatic Tachycardia Syndrome

Jan 3Confirmed

SEC

00%

10mo

ETONPDUFA$490M

NDA

FDA PDUFA Date ET-105 (standard)

ET-105• adult refractory gastroesophageal reflux disease (rGERD)

Jan 18Confirmed

SEC

00%

10mo

HRMYPDUFA$904M

NDA

FDA PDUFA Date HBS-102 (standard)

HBS-102• narcolepsy

Jan 18Confirmed

SEC

00%

10mo

IRDPDUFA$338M

NDA

FDA PDUFA Date OPX-102 (standard)

OPX-102• Achromatopsia

Jan 20Confirmed

SEC

00%

11mo

VNDAPDUFA$489M

Phase 2

FDA PDUFA Date Imsidolimab (standard review)

Imsidolimab• Acne Vulgaris

Jan 28AI-detected

Source

00%

February 20276

11mo

CELG-RIPDUFA

Phase 3

FDA PDUFA Date iberdomide

Iberdomide• Multiple Myeloma

Feb 12AI-detected

Source

00%

11mo

DCPHPDUFA

NDA

FDA PDUFA Date Tirabrutinib

Tirabrutinib• relapsed or refractory PCNSL

Feb 12AI-detected

Source

00%

11mo

OCULPDUFA$1.1B

NDA

FDA PDUFA Date AXPAXLI

AXPAXLI• wet-AMD

Feb 12AI-detected

Source

00%

11mo

TEVAPDUFA$18.3B

NDA

FDA PDUFA Date olanzapine extended-release injectable suspension (standard review)

olanzapine extended-release injectable suspension• schizophrenia in adults

Feb 15AI-detected

Source

00%

11mo

MLTXPDUFA$1.1B

NDA

FDA PDUFA Date

• inflammatory arthritis

Feb 17AI-detected

Source

00%

12mo

RAREPDUFA$3.7B

NDA

FDA PDUFA Date (standard)

Feb 24Confirmed

SEC

00%

March 20272

12mo

GSKPDUFA$99.3B

Phase 2

FDA PDUFA Date GSK2857916 (priority)

Feladilimab• Multiple Myeloma

Mar 1Confirmed

SEC

00%

12mo

XENEPDUFA$2.9B

Phase 3

FDA PDUFA Date azetukalner (standard review)

Azetukalner• Major Depressive Disorder

Mar 4AI-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.