Veraxa Biotech stock gains on FDA-aligned testing strategy

Investing.com -- Veraxa Biotech AG (NASDAQ: VRXA) shares rose 3.7% in premarket trading Wednesday following the company's announcement of a strategy to implement FDA-aligned New Approach Methodologies across its preclinical programs.

The antibody-based cancer therapy developer said the approach could enable faster clinical advancement while significantly reducing animal testing. The strategy positions the company ahead of the FDA's 2025 roadmap, which encourages phased reduction of animal testing in favor of human-relevant, non-animal test methods.

New Approach Methodologies include cell-based assays, organ-on-chip systems, computational modeling and ex vivo tissue models designed to predict human biological responses while reducing dependence on animal models. The company said the shift is expected to reduce development costs and timelines by bypassing certain non-human primate toxicology studies traditionally required ahead of clinical development.

Veraxa has been building a panel of these methodologies to characterize its pipeline of BiTAC-based T cell engagers, BiTAC-based antibody drug conjugates and bispecific antibody-drug conjugates. The company presented initial data on its BiTAC-TCE program at the AACR Annual Meeting 2026, showing the candidate attacked cancer cells displaying both target molecules while sparing cells expressing only one of the two.

The company evaluated its lead BiTAC-TCE and bsADC candidates in an ex vivo panel of ten low-passage patient-derived xenograft models of non-small cell lung cancer. The panel required approximately ten mice in total, versus an estimated 200 or more for comparable in vivo efficacy studies, according to the company.

Across the panel, the combined BiTAC induced T cell-mediated killing, while commercial T cell engagers against non-expressed targets showed minimal activity, the company said.

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