Newron Pharmaceuticals

Newron has received a written document from the FDA regarding the clinical hold in US study sites that has been in place since April 2026 and is reviewing the feedback while preparing a response. The agency expressed concerns that sodium channel blockers such as Evenamide could trigger cardiac arrhythmias and pointed to four deaths in the Evenamide group versus one in the placebo group. Newron emphasizes that it has not seen a pattern of cardiac abnormalities in the available safety data and relies on over 10,000 electrocardiograms from around 700 treated individuals. The Phase 3 study ENIGMA-TRS 1 is expected to be fully enrolled by mid-October 2026; initial 12-week results are expected in Q1 2027. ENIGMA-TRS 2 continues outside the US, while the clinical hold remains in the US. » Altro su finanzen.net

The US regulator FDA has confirmed the enrollment hold for the Phase‑3 ENIGMA‑TRS 2 study of Evenamide in the US after an unexpected death of a study participant outside the US. Newron is continuing recruitment outside the US and is establishing additional study sites in Europe, Asia and Latin America. Around 80 patients have started so far; at least 400 participants are planned. The company expects a written FDA letter with details and possible protocol amendments. » Altro su finanzen.net

An investor group subscribed to 433,070 new shares, providing Newron with €5.5 million gross. The shares are to be traded on SIX from Tuesday. The financing is part of a package of up to €38 million to continue the phase‑III development of Evenamide; a further €5.5 million is to follow by the end of November and an additional €12 million is linked to positive phase‑III results. With the funds, Newron intends to advance the development of Evenamide as an adjunct therapy for treatment‑resistant schizophrenia and to secure funding beyond the pivotal 12‑week data. » Altro su finanzen.net