How many clinical-trial readouts are scheduled for September 2027?

pdufa.bio currently tracks 33 clinical-trial readouts with dates in September 2027, each linked to a primary source. The list updates as new filings appear and dates shift.

What is a clinical-trial readout date?

A readout date is the estimated time a trial reports topline results, based on its registered primary-completion date; these are estimates and shift.

Does pdufa.bio predict whether these will be approved?

No. We do not publish per-drug approval probabilities. We provide the verified facts, primary-source links, and historical base rates so you can judge for yourself.

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Home › Readouts › September 2027

September 2027 clinical-trial readouts

Updated August 7, 2026·next FDA decision on the calendar

trial-readout estimates for September 2027, each row linked to its primary source. Readout dates are estimated primary-completion windows from ClinicalTrials.gov and shift.

← August 2027 October 2027 →

14 readouts

BHVN · Sep 2027 (est.)

BHV-1300: Graves Disease

CHRS · Sep 2027 (est.)

CHS-1420: Hepatocellular Carcinoma

Awaiting data

CSTL · Sep 2027 (est.)

FCX-007: Dystrophic Epidermolysis Bullosa

Awaiting data

HUMA · Sep 2027 (est.)

Human Acellular Vessel: Trauma

Awaiting dataupdated 32mo ago

IMVT · Sep 2027 (est.)

IMVT-1402: Rheumatoid Arthritis

Awaiting data

SMMT · Sep 2027 (est.)

Ivonescimab: Metastatic Esophageal Adenocarcinoma

TLSI · Sep 2027 (est.)

Pembrolizumab: Locally Advanced Pancreatic Adenocarcinoma

Awaiting dataupdated 12mo ago

UPB · Sep 2027 (est.)

Verekitug: Severe Asthma

Awaiting data

AGEN · Sep 2027 (est.)

Botensilimab: Metastatic Colorectal Cancer

Awaiting dataupdated 10mo ago

INCY · Sep 2027 (est.)

Corticosteroids: Chronic Graft-versus-host-disease

CNTA · Sep 2027 (est.)

cleminorexton: Narcolepsy Type 1

IVA · Sep 2027 (est.)

IVA337: NASH - Nonalcoholic Steatohepatitis

Awaiting data

MAIA · Sep 2027 (est.)

6-Thio-2'-Deoxyguanosine: Carcinoma, Non-Small-Cell Lung

Awaiting data

VNDA · Sep 2027 (est.)

Tradipitant: Motion Sickness

Looking for an approval probability for these? We deliberately don't publish one. Here's why, and what we show instead (verified history + base rates).