Newron Pharmaceuticals

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

An investor group has subscribed for a second tranche of 433,070 newly issued Newron shares at EUR 19.24 per share, representing gross proceeds of EUR 5.5 million. The subscription is part of a total financing package of up to EUR 38 million to continue the global ENIGMA‑TRS phase‑3 program for Evenamide in treatment‑resistant schizophrenia. A third tranche of EUR 5.5 million is planned no later than 30 November 2026, and further shares worth EUR 12 million are to be subscribed if pivotal study results are positive. The new shares will trade under the same ISIN and be listed on SIX, the primary market in Düsseldorf, and the Xetra Quotation Board. » Altro su de.investing.com