INBS biotech catalysts & pipeline

INTELLIGENT BIO SOLUTIONS INC · Data as of 2026-09-08

Upcoming catalysts

Intelligent Fingerprinting Drug Screening System — PDUFA

H2 2026

The Company anticipates FDA 510(k) clearance in the second half of the 2026 calendar year.

Source filing

Intelligent Fingerprinting Drug Screening System — Regulatory decision

H2 2026

INBS anticipates FDA 510(k) clearance in the second half of the 2026 calendar year.

Source filing

Intelligent Fingerprinting Drug Screening System — NDA/BLA submission

H2 2026

The Company remains on track to submit its 510(k) package in calendar H2 2026, working toward planned entry into the multi-billion-dollar U.S. drug screening market

Source filing

Intelligent Fingerprinting Drug Screening System — NDA/BLA submission

Sep 2026

With all data collection now complete, the Company has accelerated its filing timeline and expects to submit its 510(k) application in September 2026, supporting its planned entry into the U.S. market following FDA clearance.

Source filing

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