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Wire · operational-macro

SystImmune clears FDA IND for SI-B037 bispecific using NAM-based toxicology package

25 September 2026 · By · Wire by Fusion42

Published

25 September 2026

Topic

operational-macro

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at allsci.com →

◆ Verified

Fusion42 · 25 September 2026 · Fusion42 review

SystImmune has received FDA clearance for its IND application for SI-B037, a bispecific antibody for advanced solid tumors, using a novel toxicology package based on New Approach Methodologies (NAMs) instead of conventional animal studies.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 22 Sep 2026 and 25 Sep 2026.

◆ ◆ The Wire takeaway

Your drug development path just opened with FDA acceptance of NAMs for toxicology. Change your safety studies this week to use organ-on-chip models to speed approval and improve human relevance.

◆ Coverage

2 sources · first reported 22 Sep 2026 · latest 25 Sep 2026

◆ Related on Wire

◆ Topics

Biotechfda-clearancebispecific-antibodynam-toxicologyoncologyclinical-trialsdrug-development