Why Is Teva Stock Trading Lower on Monday?

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), will discontinue its Phase 2 TOPAS-MSA study evaluating emrusolmin in adult patients with multiple system atrophy.

Interim Futility Analysis Signals Low Efficacy Probability

The company decided on a recommendation from an independent data monitoring committee.

That committee conducted a prespecified interim futility assessment, which demonstrated a low probability that the study would achieve its primary efficacy goal if it continued.

While researchers identified no safety concerns, the predictive review prompted the early halt ahead of any final efficacy analysis.

Ongoing Evaluation And Broader Program Outlook

Teva currently develops emrusolmin in collaboration with MODAG GmbH.

The drugmaker emphasized that the present discontinuation strictly impacts the TOPAS-MSA trial and does not represent a conclusion regarding the broader emrusolmin clinical program.

Teva plans to collaborate directly with trial investigators to ensure adherence to study protocols throughout the Phase 2 wind-down.

Furthermore, the company will conduct a comprehensive evaluation combining TOPAS-MSA data with available results from an open-label extension study before presenting the findings to the scientific community.

In August, Teva stipulated that Aurinia Pharmaceuticals Inc.’s (NASDAQ:AUPH) U.S. Patent Nos. 10,286,036 and 11,622,991 (which expire in December 2037) are enforceable, valid, and would be infringed by commercial sales within the ‎U.S. of its generic voclosporin product.

The settlement further provides that Teva may launch its generic voclosporin product no earlier than December 7, 2036, unless certain defined contingencies occur earlier.

TEVA Price Action: Teva Pharmaceutical Indus shares were down 2.3% at $41.12 at last check on Monday. The stock is approaching its 52-week high of $42.02, according to Benzinga Pro data.

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