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Sparks commentary - Newron Pharmaceuticals

Healthcare

Sparks - Newron Pharmaceuticals

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Newron Pharmaceuticals (SIX: NWRN): ENIGMA-TRS2 advances in other countries while US on pause
Published by Arron Aatkar, PhD

The FDA has maintained its hold on new US enrolment in Newron’s Phase III ENIGMA-TRS 2 trial of evenamide for treatment resistant schizophrenia. The hold followed a sudden death at a site outside the US, which the investigator assessed as unrelated to treatment. Newron is expanding ENIGMA-TRS 2 sites in Europe, Asia and Latin America, with around 80 patients in screening towards a target of at least 400.

ENIGMA-TRS 1 continues in 20 countries, with at least 600 patients expected to be enrolled by mid-October and its primary readout expected in Q127. The FDA’s forthcoming written feedback should clarify whether further protocol changes are needed.

See our prior update note for a more detailed discussion on Newron.

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