September 2027 Catalysts

FDA Decisions & PDUFA Dates

October 2027

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Aug 30 - Sep 5(9 catalysts)

AZNCF$290.6BPhase 2

Q3 '27

Fulvestrant injection Phase 2 Est. Readout

Fulvestrant injection1,100

ER+ Breast Cancer

Q3 2027~QConfirmed

00%

CT.gov

BNN.DE$66MPhase 2

Q3 '27

INS-GSH Phase 2 Est. Readout

INS-GSH56

Parkinson Disease

Q3 2027~QConfirmed

00%

CT.gov

DSKYF$28.8BPhase 2

Q3 '27

HER3-DXd Phase 2 Est. Readout

HER3-DXd740

Advanced Solid Tumor

Q3 2027~QConfirmed

00%

CT.gov

NVO$203.2BPhase 3

Q3 '27

Cagrilintide Phase 3 Est. Readout

Cagrilintide7,101

Obesity or Overweight

Q3 2027~QConfirmed

00%

CT.gov

IPN.PA$14.5BPhase 2

Q3 '27

NALIRIFOX Phase 2 Est. Readout

NALIRIFOX60

Pancreatic Ductal Adenocarcinoma

Q3 2027~QConfirmed

00%

CT.gov

NVO$203.2BPhase 2

Q3 '27

NNC0662-0419 Phase 2 Est. Readout

NNC0662-0419270

Overweight

Q3 2027~QConfirmed

00%

CT.gov

NONOF$215.0BPhase 2

Q3 '27

Semaglutide Phase 2 Est. Readout

NNC0662-0419270

Diabetes Mellitus, Type 2

Q3 2027~QConfirmed

00%

CT.gov

TRAX$608MPDUFA

Sep '27

FDA PDUFA Date MOGENRY

MOGENRYNDA

Retinitis Pigmentosa with Severe Vision Loss

Sep 2027~AI-detected

00%

Source

CLTS$431KPhase 2

Q3 '27

18F-rhPSMA-7.3 (Posluma) Phase 2 Est. Readout

18F-rhPSMA-7.3 (Posluma)30

Prostate Cancer (Post Prostatectomy)

Q3 2027~QConfirmed

00%

CT.gov

Week 2Sep 6 - Sep 12(8 catalysts)

BIIB$29.0BPhase 2

Q3 '27

Placebo Phase 2 Est. Readout

SAGE-217275

Bipolar Disorder I

Q3 2027~QConfirmed

00%

CT.gov

BIIB$29.0BPhase 2

Q3 '27

BIIB091 Phase 2 Est. Readout

BIIB091127

Relapsing Forms of Multiple Sclerosis

Q3 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q3 '27

Placebo Phase 2 Est. Readout

Dupilumab90

Atopic Dermatitis (AD)

Q3 2027~QConfirmed

00%

CT.gov

NVSEF$269.0BPhase 2

Q3 '27

PKN605 Phase 2 Est. Readout

PKN605165

Atrial Fibrillation

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

Oral dabrafenib and trametinib Phase 2 Est. Readout

Oral dabrafenib and trametinib25

Craniopharyngioma

Q3 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q3 '27

PCV21 vaccine Phase 3 Est. Readout

PCV21 vaccine580

Pneumococcal Immunization

Q3 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q3 '27

M-M-R II vaccine Phase 3 Est. Readout

M-M-R II vaccine580

Pneumococcal Immunization

Q3 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q3 '27

Prevnar 20 vaccine Phase 3 Est. Readout

Prevnar 20 vaccine580

Pneumococcal Immunization

Q3 2027~QConfirmed

00%

CT.gov

Week 3Sep 13 - Sep 19(39 catalysts)

SNY$100.0BPhase 2

Q3 '27

Isatuximab Phase 2 Est. Readout

Isatuximab258

Plasma Cell Myeloma Refractory

Q3 2027~QConfirmed

00%

CT.gov

TKPHF$47.7BPhase 3

Q3 '27

Vedolizumab IV Phase 3 Est. Readout

Vedolizumab IV120

Ulcerative Colitis

Q3 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q3 '27

Belumosudil Phase 2 Est. Readout

Belumosudil258

Chronic Graft Versus Host Disease

Q3 2027~QConfirmed

00%

CT.gov

UPB$340MPhase 2

Sep '27

Verekitug Phase 2 Est. Readout

Verekitug396

Severe Asthma

Sep 2027~Confirmed

00%

CT.gov

BTMD$98MPhase 2

Sep '27

IMA402 (Phase Ia) Phase 2 Est. Readout

IMA402 (Phase Ia)400

Refractory Cancer

Sep 2027~Confirmed

00%

CT.gov

DFTX$2.7BPhase 3

Sep '27

DT120 Phase 3 Est. Readout

DT120165

Major Depressive Disorder

Sep 2027~Confirmed

00%

CT.gov

CHRS$228MPhase 2

Sep '27

Casdozokitug Phase 2 Est. Readout

Casdozokitug72

Hepatocellular Carcinoma

Sep 2027~Confirmed

00%

CT.gov

ARGX$56.5BPhase 3

Sep '27

empasiprubart Phase 3 Est. Readout

empasiprubart218

Chronic Inflammatory Demyelinating Polyneuropathy

Sep 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Sep '27

Upadacitinib Phase 3 Est. Readout

Upadacitinib747

Ulcerative Colitis (UC)

Sep 2027~Confirmed

00%

CT.gov

GMAB$15.7BPhase 2

Sep '27

Epcoritamab (monotherapy) Phase 2 Est. Readout

Epcoritamab (monotherapy)78

Diffuse Large B Cell Lymphoma

Sep 2027~Confirmed

00%

CT.gov

SKBBYPhase 2

Sep '27

SKB264 Phase 2 Est. Readout

SKB264175

Metastatic Breast Cancer

Sep 2027~Confirmed

00%

CT.gov

IPN.PA$14.5BPhase 2

Sep '27

Panitumumab Phase 2 Est. Readout

Panitumumab1,550

Cancer

Sep 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Sep '27

Odetiglucan Phase 2 Est. Readout

Odetiglucan27

Colorectal Adenocarcinoma Metastatic in the Liver

Sep 2027~Confirmed

00%

CT.gov

AGEN$125MPhase 2

Sep '27

Balstilimab Phase 2 Est. Readout

Balstilimab234

Advanced Melanoma

Sep 2027~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Sep '27

bemarituzumab, paclitaxel, ramucirumab Phase 2 Est. Readout

bemarituzumab, paclitaxel, ramucirumab126

Metastatic Gastro-esophageal Adenocarcinoma

Sep 2027~Confirmed

00%

CT.gov

SKBBYPhase 2

Sep '27

KL-A167 Phase 2 Est. Readout

KL-A167175

Nasopharyngeal Carcinoma

Sep 2027~Confirmed

00%

CT.gov

ARGX$56.5BPhase 3

Sep '27

Efgartigimod PH20 SC Phase 3 Est. Readout

Efgartigimod PH20 SC12

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Sep 2027~Confirmed

00%

CT.gov

OTSKF$34.0BPhase 3

Sep '27

OPC-34712FUM/ Brexpiprazole fumarate Phase 3 Est. Readout

OPC-34712FUM/ Brexpiprazole fumarate450

Acute Schizophrenia

Sep 2027~Confirmed

00%

CT.gov

ALPMY$24.1BPhase 2

Sep '27

ASP3082 Phase 2 Est. Readout

ASP308260

Metastatic/Locally Advanced Non-Small-Cell Lung Cancer

Sep 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 2

Sep '27

Icalcaprant Phase 2 Est. Readout

Icalcaprant195

Major Depressive Disorder

Sep 2027~Confirmed

00%

CT.gov

RARE$2.7BPhase 3

Sep '27

Oral Corticosteroids Phase 3 Est. Readout

Oral Corticosteroids37

OTC Deficiency

Sep 2027~Confirmed

00%

CT.gov

DSKYF$28.8BPhase 2

Sep '27

Patritumab deruxtecan Phase 2 Est. Readout

Patritumab Deruxtecan152

Nonsquamous Non-small Cell Lung Cancer

Sep 2027~Confirmed

00%

CT.gov

ALPMY$24.1BPhase 3

Sep '27

Leuprorelin Acetate Phase 3 Est. Readout

leuprorelin acetate700

Prostate Cancer

Sep 2027~Confirmed

00%

CT.gov

BNN.DE$66MPhase 2

Sep '27

Sertraline Phase 2 Est. Readout

Sertraline130

Neurodevelopmental Disorders

Sep 2027~Confirmed

00%

CT.gov

AMGN$182.2BPhase 3

Sep '27

Blinatumomab Phase 3 Est. Readout

Blinatumomab160

Acute Lymphoblastic Leukemia

Sep 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Sep '27

Pembrolizumab Phase 2 Est. Readout

pembrolizumab27

Colorectal Neoplasms

Sep 2027~Confirmed

00%

CT.gov

CSTL$641MPhase 3

Sep '27

D-Fi Phase 3 Est. Readout

D-Fi32

Dystrophic Epidermolysis Bullosa

Sep 2027~Confirmed

00%

CT.gov

CORT$8.6BPhase 2

Sep '27

Gemcitabine 1000 mg/m^2 Phase 2 Est. Readout

Gemcitabine 1000 mg/m^260

Adenocarcinoma

Sep 2027~Confirmed

00%

CT.gov

NYKD.OL$99MPhase 2

Sep '27

VB10.16 Phase 2 Est. Readout

VB10.1651

Cervical Cancer

Sep 2027~Confirmed

00%

CT.gov

LLY$1.0TPhase 3

Sep '27

Retatrutide Phase 3 Est. Readout

Retatrutide586

Obesity

Sep 2027~Confirmed

00%

CT.gov

IONS$12.2BPhase 2

Sep '27

ION440 Phase 2 Est. Readout

ION44048

Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome

Sep 2027~Confirmed

00%

CT.gov

KYTX$491MPhase 3

Sep '27

Standard of Care Treatment Phase 3 Est. Readout

Standard of Care Treatment66

Myasthenia Gravis

Sep 2027~Confirmed

00%

CT.gov

CYTK$9.8BPhase 3

Sep '27

Omecamtiv Mecarbil (OM) Phase 3 Est. Readout

Omecamtiv Mecarbil (OM)1,800

Heart Failure

Sep 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Sep '27

Armour Thyroid Phase 3 Est. Readout

Armour Thyroid2,800

Hypothyroidism

Sep 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 2

Sep '27

Lutikizumab Phase 2 Est. Readout

Lutikizumab156

Hidradenitis Suppurativa

Sep 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 2

Sep '27

Adalimumab Phase 2 Est. Readout

adalimumab156

Pyoderma Gangrenosum

Sep 2027~Confirmed

00%

CT.gov

JNGHFPhase 2

Sep '27

HRS-4508 tablet Phase 2 Est. Readout

HRS-4508 tablet120

Solid Tumor

Sep 2027~Confirmed

00%

CT.gov

REPL$841MPhase 2

Sep '27

RP1, intra-tumoral injection, oncolytic virus Phase 2 Est. Readout

RP1, intra-tumoral injection, oncolytic virus65

Cutaneous Squamous Cell Carcinoma

Sep 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Q3 '27

Nemtabrutinib Phase 2 Est. Readout

Nemtabrutinib190

Chronic Lymphocytic Leukemia

Q3 2027~QConfirmed

00%

CT.gov

Week 4Sep 20 - Sep 26

No catalysts this week

Week 5Sep 27 - Oct 3

No catalysts this week

August 2027 Full Calendar October 2027

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About PDUFA Dates in September 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for September 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.