August 2027 Catalysts

FDA Decisions & PDUFA Dates

September 2027

100

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Jul 26 - Aug 1(5 catalysts)

DSKYF$28.8BPhase 3

Q3 '27

Carboplatin Phase 3 Est. Readout

CS-10081,170

Non-small Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q3 '27

Pembrolizumab 200 mg IV infusion Phase 2 Est. Readout

Pembrolizumab 200 mg IV infusion70

Stage IIIB(N2) Non-small Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q3 '27

Pembrolizumab Phase 2 Est. Readout

pembrolizumab26

Colorectal Neoplasms

Q3 2027~QConfirmed

00%

CT.gov

TOVX$12MPhase 2

Q3 '27

VCN-01 oncolytic adenovirus (zabilugene almadenorepvec) Phase 2 Est. Readout

VCN-01 oncolytic adenovirus (zabilugene almadenorepvec)6

Pancreas Cancer, Metastatic

Q3 2027~QConfirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Q3 '27

AP1189, 100 mg Phase 2 Est. Readout

AP1189, 100 mg96

Respiratory Viral Infection

Q3 2027~QConfirmed

00%

CT.gov

Week 2Aug 2 - Aug 8(10 catalysts)

AZNCF$290.6BPhase 3

Q3 '27

Osimertinib Phase 3 Est. Readout

Osimertinib390

Non-Small Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

JHPCY$45.1BPDUFA

Aug '27

FDA PDUFA Date AP301

HS-20093 for InjectionPhase 2

Prostate Cancer

Aug 2027~Confirmed

00%

Source

AZN$273.6BPhase 2

Q3 '27

AZD8421 Phase 2 Est. Readout

AZD8421564

ER+ HER2- Advanced Breast Cancer

Q3 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 2

Q3 '27

PF-08653945 Phase 2 Est. Readout

PF-08653945872

Overweight

Q3 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q3 '27

Elranatamab Phase 3 Est. Readout

Elranatamab854

Multiple Myeloma

Q3 2027~QConfirmed

00%

CT.gov

NHPAPPDUFA

Aug '27

FDA PDUFA Date LAE002 (afuresertib)

LAE002 (afuresertib)NDA

treatment of patients with [indication not fully specified in text]

Aug 2027~AI-detected

00%

Source

BIIB$29.0BPhase 3

Q3 '27

Tofersen Phase 3 Est. Readout

Tofersen158

ALS (SOD1)

Q3 2027~QConfirmed

00%

BTDFTOrphanCT.gov

AZNCF$290.6BPhase 3

Q3 '27

Tezepelumab Phase 3 Est. Readout

Tezepelumab400

Asthma

Q3 2027~QConfirmed

00%

CT.gov

BIIB$29.0BPhase 3

Q3 '27

Placebo Phase 3 Est. Readout

SAGE-217158

Bipolar Disorder I

Q3 2027~QConfirmed

00%

CT.gov

SGIOY$14.8BPhase 2

Q3 '27

S-606001 Phase 2 Est. Readout

S-60600145

Pompe Disease

Q3 2027~QConfirmed

00%

CT.gov

Week 3Aug 9 - Aug 15(51 catalysts)

REGN$57.3BPhase 2

Q3 '27

ALN-PNP Phase 2 Est. Readout

ALN-PNP172

Healthy Volunteers

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q3 '27

ISL Phase 2 Est. Readout

ISL150

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Q3 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Q3 '27

Acalabrutinib Phase 2 Est. Readout

Acalabrutinib20

Phase I: Relapsed or Refractory B-cell Malignancies

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q3 '27

BIC/FTC/TAF Phase 2 Est. Readout

BIC/FTC/TAF150

HIV-1 Infection

Q3 2027~QConfirmed

00%

CT.gov

NVSEF$269.0BPhase 3

Q3 '27

BION-1301 Phase 3 Est. Readout

BION-1301383

IgA Nephropathy

Q3 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 3

Q3 '27

Baxdrostat Phase 3 Est. Readout

Baxdrostat250

Primary Hyperaldosteronism

Q3 2027~QConfirmed

00%

CT.gov

IMCR$1.5BPhase 2

Aug '27

Tebentafusp-Tebn Phase 2 Est. Readout

Tebentafusp-Tebn19

Locally Advanced Unresectable Uveal Melanoma

Aug 2027~Confirmed

00%

CT.gov

ESALYPhase 2

Aug '27

Lenvatinib + Letrozole Phase 2 Est. Readout

Lenvatinib + Letrozole120

Breast Cancer

Aug 2027~Confirmed

00%

CT.gov

GTHXPhase 2

Aug '27

Trilaciclib Phase 2 Est. Readout

Trilaciclib36

TNBC - Triple-Negative Breast Cancer

Aug 2027~Confirmed

00%

CT.gov

IPIX$9MPhase 2

Aug '27

S095029 Phase 2 Est. Readout

S09502948

MSI-H/dMMR Gastroesophageal-junction Cancer

Aug 2027~Confirmed

00%

CT.gov

COAG$1.4BPhase 2

Aug '27

HMB-001 Phase 2 Est. Readout

HMB-00157

Glanzmann Thrombasthenia

Aug 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Aug '27

Venetoclax Phase 3 Est. Readout

Venetoclax165

Acute Myeloid Leukemia (AML)

Aug 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Aug '27

Risankizumab Phase 3 Est. Readout

Vedolizumab573

Ulcerative Colitis

Aug 2027~Confirmed

00%

CT.gov

SUPN$2.6BPhase 2

Aug '27

SPN-817 Phase 2 Est. Readout

SPN-817216

Focal Onset Seizures

Aug 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Aug '27

Telisotuzumab Adizutecan Phase 3 Est. Readout

Trifluridine/Tipiracil74

Metastatic Colorectal Cancer

Aug 2027~Confirmed

00%

CT.gov

AAPG$6.4BPhase 3

Aug '27

Acalabrutinib Phase 3 Est. Readout

Acalabrutinib344

CLL/SLL

Aug 2027~Confirmed

00%

CT.gov

ASND$15.0BPhase 2

Aug '27

TransCon IL-2 β/γ Phase 2 Est. Readout

TransCon IL-2 β/γ320

Advanced Solid Tumor

Aug 2027~Confirmed

00%

CT.gov

ACAD$3.7BPhase 2

Aug '27

ACP-211 Phase 2 Est. Readout

ACP-211153

Major Depressive Disorder (MDD)

Aug 2027~Confirmed

00%

CT.gov

LNTH$6.8BPhase 2

Aug '27

LNTH2403 Phase 1 dose Phase 2 Est. Readout

LNTH2403 Phase 1 dose55

Relapsed / Refractory Osteosarcoma

Aug 2027~Confirmed

00%

CT.gov

DCPHPhase 2

Aug '27

Inlexisertib Phase 2 Est. Readout

Inlexisertib144

Non-Small Cell Lung Cancer

Aug 2027~Confirmed

00%

CT.gov

IPIX$9MPhase 2

Aug '27

ANO31905 Phase 2 Est. Readout

ANO3190584

Pancreatic Cancer

Aug 2027~Confirmed

00%

CT.gov

PVLA$1.6BPhase 2

Aug '27

PTX-022 Phase 2 Est. Readout

PTX-02215

Pachyonychia Congenita

Aug 2027~Confirmed

00%

CT.gov

IONS$12.2BPhase 3

Aug '27

ION582 Phase 3 Est. Readout

ION582158

Angelman Syndrome

Aug 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Aug '27

Upadacitinib Phase 3 Est. Readout

Upadacitinib56

Ulcerative Colitis (UC)

Aug 2027~Confirmed

00%

CT.gov

TVTX$5.1BPhase 3

Aug '27

Pegtibatinase Phase 3 Est. Readout

Pegtibatinase70

Homocystinuria

Aug 2027~Confirmed

00%

CT.gov

AAPG$6.4BPhase 3

Aug '27

Lisaftoclax (APG-2575) Phase 3 Est. Readout

Lisaftoclax (APG-2575)344

Relapsed/Refractory Acute Myeloid Leukaemia

Aug 2027~Confirmed

00%

CT.gov

BHVN$2.0BPhase 3

Aug '27

BHV-8000 Phase 3 Est. Readout

BHV-8000550

Parkinson Disease

Aug 2027~Confirmed

00%

CT.gov

ZLAB$1.6BPhase 2

Aug '27

ZL-1310 Phase 2 Est. Readout

ZL-1310112

Solid Tumors

Aug 2027~Confirmed

00%

CT.gov

RARE$2.7BPhase 3

Aug '27

Triheptanoin Phase 3 Est. Readout

Triheptanoin69

Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)

Aug 2027~Confirmed

00%

CT.gov

EYPT$1.1BPhase 3

Aug '27

EYP-1901 Phase 3 Est. Readout

EYP-1901240

Diabetic Macular Edema

Aug 2027~Confirmed

00%

CT.gov

KPRX$9MPhase 2

Aug '27

100 μg KIO-301 Phase 2 Est. Readout

100 μg KIO-30136

Retinitis Pigmentosa

Aug 2027~Confirmed

00%

CT.gov

ASND$15.0BPhase 2

Aug '27

Navepegritide Phase 2 Est. Readout

Navepegritide24

Achondroplasia

Aug 2027~Confirmed

00%

CT.gov

CRNX$3.8BPhase 2

Aug '27

CRN09682 Phase 2 Est. Readout

CRN09682150

SST2-positive Neuroendocrine Neoplasms

Aug 2027~Confirmed

00%

CT.gov

AVEOPhase 3

Aug '27

Ficlatuzumab Phase 3 Est. Readout

Ficlatuzumab410

Metastatic Head-and-neck Squamous-cell Carcinoma

Aug 2027~Confirmed

00%

CT.gov

CLLS$284MPhase 2

Aug '27

UCART20x22 Phase 2 Est. Readout

UCART20x2280

B-cell Non-Hodgkin Lymphoma (B-NHL)

Aug 2027~Confirmed

00%

CT.gov

IONS$12.2BPhase 2

Aug '27

ION582 Phase 2 Est. Readout

ION58270

Angelman Syndrome

Aug 2027~Estimated

00%

CT.gov

CRNX$3.8BPhase 3

Aug '27

Paltusotine Phase 3 Est. Readout

Paltusotine141

Acromegaly

Aug 2027~Confirmed

00%

CT.gov

JNJ$549.8BPhase 2

Aug '27

Oral Dexamethasone Phase 2 Est. Readout

Oral Dexamethasone100

Multiple Myeloma

Aug 2027~Confirmed

00%

CT.gov

JNJ$549.8BPhase 2

Aug '27

Talquetamab Phase 2 Est. Readout

Talquetamab100

Multiple Myeloma

Aug 2027~Confirmed

00%

CT.gov

IPN.PA$14.5BPhase 2

Aug '27

Nanoliposomal irinotecan Phase 2 Est. Readout

Nanoliposomal Irinotecan36

Advanced Biliary Tract Cancer

Aug 2027~Confirmed

00%

CT.gov

IPN.PA$14.5BPhase 2

Aug '27

5 fluorouracil Phase 2 Est. Readout

5 fluorouracil36

Small Bowel Adenocarcinoma

Aug 2027~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Aug '27

Fianlimab Phase 2 Est. Readout

Fianlimab76

Melanoma

Aug 2027~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Aug '27

Platinum Doublet Chemotherapy (PDC) Phase 2 Est. Readout

Platinum Doublet Chemotherapy (PDC)76

NSCLC

Aug 2027~Confirmed

00%

CT.gov

OTSKF$34.0BPhase 3

Aug '27

EB-1020 (Centanafadine) high dose Phase 3 Est. Readout

EB-1020 (Centanafadine) high dose180

Attention-Deficit Hyperactivity Disorder(ADHD)

Aug 2027~Confirmed

00%

CT.gov

OTSKF$34.0BPhase 3

Aug '27

EB-1020 (Centanafadine) low dose Phase 3 Est. Readout

EB-1020 (Centanafadine) low dose180

Attention-Deficit Hyperactivity Disorder(ADHD)

Aug 2027~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Aug '27

ZED1227 + SIGE Phase 2 Est. Readout

ZED1227 + SIGE356

Celiac Disease

Aug 2027~Confirmed

00%

CT.gov

OCUPPhase 3

Aug '27

0.75% Phentolamine Ophthalmic Solution Phase 3 Est. Readout

0.75% Phentolamine Ophthalmic Solution580

Vision Loss Night

Aug 2027~Confirmed

00%

CT.gov

PRLD$344MPhase 2

Aug '27

PRT3789 Phase 2 Est. Readout

PRT37897

Advanced Solid Tumor

Aug 2027~Confirmed

00%

CT.gov

APLS$5.3BPhase 3

Aug '27

Pegcetacoplan Phase 3 Est. Readout

Pegcetacoplan320

C3G

Aug 2027~Confirmed

00%

CT.gov

MNMD$515MPhase 2

Aug '27

MM402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) Phase 2 Est. Readout

MM402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))20

Autism Spectrum Disorder

Aug 2027~Confirmed

00%

CT.gov

ZLAB$1.6BPhase 3

Aug '27

ZL-1310 Phase 3 Est. Readout

ZL-1310480

Solid Tumors

Aug 2027~Estimated

00%

CT.gov

Week 4Aug 16 - Aug 22(8 catalysts)

NHPAPPDUFA

Aug '27

FDA PDUFA Date Opamtistomig

OpamtistomigNDA

PD-L1/4-1BB Bispecific Antibody

Aug 2027~AI-detected

00%

Source

AZNCF$290.6BPhase 2

Q3 '27

AZD0305 Phase 2 Est. Readout

AZD0305226

Multiple Myeloma

Q3 2027~QConfirmed

00%

CT.gov

VSTM$362MPhase 2

Q3 '27

Avutometinib Phase 2 Est. Readout

avutometinib30

Low Grade Serous Ovarian Cancer

Q3 2027~QConfirmed

00%

CT.gov

VSTM$362MPhase 2

Q3 '27

Defactinib Phase 2 Est. Readout

Defactinib30

Pancreatic Adenocarcinoma

Q3 2027~QConfirmed

00%

CT.gov

UTHR$22.8BPDUFA

Aug '27

FDA PDUFA Date Ralinepag

RalinepagPhase 3

Pulmonary Arterial Hypertension

Aug 2027~Confirmed

00%

Source

ARWR$11.5BPhase 3

Q3 '27

zodasiran Injection Phase 3 Est. Readout

zodasiran Injection60

Homozygous Familial Hypercholesterolemia

Q3 2027~QConfirmed

00%

CT.gov

TXMD$9MPhase 2

Q3 '27

Etavopivat Phase 2 Est. Readout

Etavopivat27

Sickle Cell Disease

Q3 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q3 '27

Mibavademab Phase 2 Est. Readout

mibavademab34

Generalized Lipodystrophy

Q3 2027~QConfirmed

00%

CT.gov

Week 5Aug 23 - Aug 29(6 catalysts)

ALLO$690MPhase 2

Q3 '27

Cyclophosphamide Phase 2 Est. Readout

ALLO-647250

Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q3 '27

Vaxneuvance vaccine Phase 3 Est. Readout

Vaxneuvance vaccine1,092

Pneumococcal Immunization

Q3 2027~QConfirmed

00%

CT.gov

TEVA$36.7BPatent Expiry

12mo

rasagiline mesylate 1.0 mg Patent Expiration

rasagiline mesylate 1.0 mgPhase 3

Parkinson's Disease

Aug 27Confirmed

Source

MRK$281.2BPhase 3

Q3 '27

9vHPV Vaccine Phase 3 Est. Readout

9vHPV vaccine6,033

Papillomavirus Infections

Q3 2027~QConfirmed

00%

CT.gov

NVO$203.2BPhase 3

Q3 '27

Etavopivat Phase 3 Est. Readout

Etavopivat510

Sickle Cell Disease

Q3 2027~QConfirmed

00%

CT.gov

INCY$19.6BPhase 2

Q3 '27

Tafasitamab Phase 2 Est. Readout

Tafasitamab25

Diffuse Large B Cell Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

Week 6Aug 30 - Sep 5(20 catalysts)

SKBBYPhase 2

Q3 '27

Envafolimab Phase 2 Est. Readout

Envafolimab126

Solid Tumor

Q3 2027~QConfirmed

00%

CT.gov

ESALYPhase 2

Q3 '27

Lenvatinib Phase 2 Est. Readout

Lenvatinib301

Hepatocellular Carcinoma

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q3 '27

Bendamustine Phase 3 Est. Readout

Bendamustine182

Follicular Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q3 '27

Recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP) Phase 2 Est. Readout

Recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP)30

Ebola Virus Disease

Q3 2027~QConfirmed

00%

CT.gov

JNGHFPhase 2

Q3 '27

HS-10365 capsules Phase 2 Est. Readout

HS-10365 capsules62

Nonsmall Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q3 '27

Linvoseltamab Phase 2 Est. Readout

Linvoseltamab150

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Q3 2027~QConfirmed

00%

CT.gov

IART$1.4BPhase 2

Q3 '27

BioDFence G3 Placental Tissue Membrane Phase 2 Est. Readout

BioDFence G3 Placental Tissue Membrane118

Prostate Cancer

Q3 2027~QConfirmed

00%

CT.gov

ESALYPhase 2

Q3 '27

E7386 Phase 2 Est. Readout

E7386301

Melanoma

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

ZN-A-1041 Phase 2 Est. Readout

ZN-A-1041210

Advanced Solid Tumors

Q3 2027~QConfirmed

00%

CT.gov

MRNA$25.4BPhase 2

Q3 '27

mRNA-3927 Phase 2 Est. Readout

mRNA-392777

Propionic Acidemia

Q3 2027~QConfirmed

00%

CT.gov

MIRM$6.5BPhase 3

Q3 '27

Brelovitug (BJT-778) Phase 3 Est. Readout

Brelovitug (BJT-778)120

Chronic Hepatitis D

Q3 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q3 '27

Belumosudil mesylate Phase 2 Est. Readout

Belumosudil mesylate36

Multiple Myeloma

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q3 '27

Tocilizumab Phase 3 Est. Readout

tocilizumab182

Rheumatoid Arthritis

Q3 2027~QConfirmed

00%

CT.gov

AMGN$182.2BPhase 2

Q3 '27

Tarlatamab Phase 2 Est. Readout

Tarlatamab32

Small Cell Lung Cancer

Q3 2027~QConfirmed

00%

BTDFTOrphanCT.gov

SKBBYPhase 2

Q3 '27

SKB571 for injection Phase 2 Est. Readout

SKB571 for injection120

Lung Cancer (Non-Small Cell)

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q3 '27

Obinutuzumab Phase 3 Est. Readout

Obinutuzumab182

Large B-cell Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

ALNY$36.9BPhase 2

Q3 '27

ALN-4324 Phase 2 Est. Readout

ALN-4324105

Obese or Overweight Healthy Volunteers

Q3 2027~QConfirmed

00%

CT.gov

KALV$1.4BPhase 3

Q3 '27

KVD900 600 mg Phase 3 Est. Readout

KVD900 600 mg48

Hereditary Angioedema

Q3 2027~QConfirmed

00%

CT.gov

CMPS$1.7BPhase 3

Q3 '27

CTX-009 Phase 3 Est. Readout

CTX-009168

Glioblastoma

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

Acetaminophen/paracetamol Phase 2 Est. Readout

Acetaminophen/Paracetamol40

Systemic Lupus Erythematosus

Q3 2027~QConfirmed

00%

CT.gov

July 2027 Full Calendar September 2027

Get August Catalysts in Your Inbox

Subscribe to receive weekly digests of upcoming PDUFA dates and clinical trial results. Never miss an important FDA decision.

About PDUFA Dates in August 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for August 2027. PDUFA dates represent FDA's target action dates for reviewing new drug applications (NDAs) and biologics license applications (BLAs).

Biotech investors and traders closely monitor these dates as FDA decisions can significantly impact stock prices. Our calendar includes PDUFA dates, clinical trial results, advisory committee meetings, and other regulatory milestones.

Learn more about PDUFA dates or view the full biotech catalyst calendar.