Last reviewed 2026-04-19 · How we verify

PHOX2B PC-CAR T Cells

Stephan Grupp MD PhD · Phase 1 active Biologic

PHOX2B PC-CAR T Cells is a Biologic drug developed by Stephan Grupp MD PhD. It is currently in Phase 1 development.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	PHOX2B PC-CAR T Cells
Sponsor	Stephan Grupp MD PhD
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

PHOX2B PC-CAR T Cells for Relapsed Neuroblastoma (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

PHOX2B PC-CAR T Cells CI brief — competitive landscape report
PHOX2B PC-CAR T Cells updates RSS · CI watch RSS
Stephan Grupp MD PhD portfolio CI

Frequently asked questions about PHOX2B PC-CAR T Cells

What is PHOX2B PC-CAR T Cells?

PHOX2B PC-CAR T Cells is a Biologic drug developed by Stephan Grupp MD PhD.

Who makes PHOX2B PC-CAR T Cells?

PHOX2B PC-CAR T Cells is developed by Stephan Grupp MD PhD (see full Stephan Grupp MD PhD pipeline at /company/stephan-grupp-md-phd).

What development phase is PHOX2B PC-CAR T Cells in?

PHOX2B PC-CAR T Cells is in Phase 1.

Manufacturer: Stephan Grupp MD PhD — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing