{"success":true,"data":{"pressRelease":{"id":"164026","rtpr_id":"nGNX4pZTpb-20261008","ticker":"NWRN","exchange":"","all_tickers":["NWRN"],"title":"Newron Provides Update on FDA Clinical Hold and Phase 3 ENIGMA-TRS Development Program","author":"Globe Newswire","published_at":"2026-10-08T11:00:00.890Z","article_body":"Management call today at 3.30 pm CEST\n\nNewron received the anticipated FDA written communication on clinical hold at\nU.S. study centers and is reviewing feedback and preparing its response\n\nENIGMA-TRS 1 enrollment expected to be completed by mid-October; topline\n12-week data expected in Q1 2027\n\nENIGMA-TRS 2 enrollment continuing outside the U.S., with additional clinical\nsites being added as planned\n\nFDA clinical hold remains in place at U.S. study centers; Newron intends to\nrespond upon thorough review and analysis of FDA feedback\n\nMILAN and MORRISTOWN, N.J., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Newron\nPharmaceuticals S.p.A.\n(https://www.globenewswire.com/Tracker?data=eE15eoD2b79889NmDhroAvuMmlFoHNpWxdgZJRHGcg9Z_LrQMh5Zx_3hv_lXW5qW89vmAsv85FvnrvymsKBo0bloGlndJg-tpqJtLYlad_I=)\n(“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on\nthe development of novel therapies for patients with diseases of the central\nand peripheral nervous system, today announced that, further to its press\nrelease on September 25 2026, the Company has in the meantime received written\ncommunication from the U.S. Food and Drug Administration (FDA) regarding the\nclinical hold at U.S. study centers in its Phase 3 ENIGMA-TRS 2 study with\nevenamide. Newron is conducting a thorough review of the FDA’s feedback and\nthe available data and intends to submit its response upon completion.\n\nNewron continues to advance the Phase 3 ENIGMA-TRS development program.\nENIGMA-TRS 1 enrollment is expected to be completed by mid-October, with\ntopline 12-week data expected in Q1 2027. ENIGMA-TRS 2 enrollment continues\noutside the U.S. Additional clinical sites are being added as planned.\n\nFDA Clinical Hold and ENIGMA-TRS Program Update\n\nThe FDA’s concern relates to the known risk that certain members of the\nclass of sodium channel blockers may trigger arrhythmias which in turn can\nlead to serious cardiovascular events or seizures. Evenamide is a glutamate\nmodulator via its action as a selective voltage-gated sodium channel blocker.\n\nIn its written communication, the FDA notes four deaths among patients treated\nwith evenamide across all clinical studies with evenamide to date, compared\nwith one death among patients receiving placebo. Of the four deaths among\npatients receiving evenamide, three were considered unrelated to evenamide by\nthe study investigators, while one was considered “possibly related”\nbecause two autopsies could not identify a definitive cause of death. The four\ndeaths have been characterized by the FDA as a potential safety signal based\non the possibility of a fatal arrhythmic mechanism, which cannot be\ndefinitively excluded through post hoc adjudication. Evenamide is also known\nto result in a very small shortening of the QTc interval on an\nelectrocardiogram (ECG). Unlike QTc prolongation, there is no established risk\nor intervention threshold for QTc shortening, and a standard screening ECG\ndoes not reliably exclude latent sodium-channel disorders in asymptomatic\npatients.\n\nNewron is reviewing the FDA’s feedback and the full body of safety data\ngenerated across the evenamide development program, which includes more than\n10,000 ECGs from approximately 700 evenamide-treated subjects and input from\nindependent cardiac electrophysiologists. Newron has not observed a pattern of\ncardiac abnormalities or arrhythmias in the preclinical and clinical safety\ndata generated with evenamide to date. This includes a thorough QT study and\nmore than 5,000 ECGs from over 700 patients with schizophrenia. As part of its\nresponse, Newron is also evaluating additional cardiac screening and\nmonitoring measures for ENIGMA-TRS 2.\n\n“We remain confident in the ENIGMA-TRS studies and encouraged by the\nprogram’s progress. Our belief in the potential of evenamide and its novel\nmechanism for patients with treatment-resistant schizophrenia remains\nstrong,” said Ravi Anand, MD, Chief Medical Officer of Newron. “Patient\nsafety is our utmost priority. Our team is working with high commitment to\ncomplete a thorough review of the FDA’s feedback and the available data, and\nto submit our response upon its completion. Our assessment is supported by the\nsubstantial body of preclinical and clinical safety data generated with\nevenamide. To date, we have not observed a pattern of cardiac abnormalities or\narrhythmias. The four deaths among patients treated with evenamide represent\nan incidence of 0.56%, compared with one death and an incidence of 0.27% among\npatients receiving placebo. When adjusted for duration of treatment, the\nmortality rate was 1.31 per 100 patient-years for evenamide compared with 1.81\nper 100 patient-years for placebo.”\n\nProfessor Dr. Peter Falkai, Chair Department of Psychiatry and Psychotherapy,\nLMU University of Munich, stated: “Schizophrenia is a tragic disease that\naffects patients in the teenage (males) and early twenties (females) and has a\ndevastating effect on their lives. In addition to multiple episodes of\npsychosis and hospitalization, patients need to take antipsychotic medication\nwith debilitating side-effects that makes them suffer from cardiac, hormonal,\nmetabolic and motor disorders. Furthermore, schizophrenia reduces\nlife-expectancy by about 10 years. TRS, a more severe form of the disease in\nwhich patients do not respond to any medication, reduces longevity by about 20\nyears.”\n\nInvestor Update Conference Call\nManagement will provide a brief update on the FDA clinical hold and ENIGMA-TRS\ndevelopment program. The call will be recorded and take place today at 3.30 pm\nCEST.\n\nThe access details:\n\n Switzerland / Europe United Kingdom United States  +41 (0) 58 310 50 00 +44 (0) 203 059 58 63 +1 (1) 631 570 56 13  \n                                                                                                                     \n\nOther international numbers available here.\n(https://www.globenewswire.com/Tracker?data=eUVUElE9sEmPmsNCp-HL7DE5ZfTQnyPpVyZjmnDC3nYdBIeDP-efuYoiFiVCWKVnbMpEyB9MN2s6Z66xw2yUG6cDO7LHdynWs1hS_E0BmUWXnHZF-0cu-Wv18hvXGXu9TY7Ba9pJjOjzBbfOKa3A-w==)\n\nAbout ENIGMA-TRS \nENIGMA-TRS 1 is an ongoing, international, 52-week, randomized, double-blind,\nplacebo-controlled Phase 3 study evaluating the efficacy, tolerability, and\nsafety of the 15mg BID and 30mg BID therapeutic doses of evenamide compared to\nplacebo. Patients on second-generation antipsychotics, including clozapine,\nwill meet Treatment Response and Resistance Psychosis international consensus\ncriteria for TRS. The study is expected to have enrolled at least 600 patients\nin the study by mid-October 2026, at study centers in 20 countries in Europe,\nAsia, Latin America, and Canada.\n\nThe primary assessment of efficacy and safety of ENIGMA-TRS 1 will be\nperformed 12 weeks after randomization to treatment. Following this initial\nperiod, the study will continue to be double-blind and placebo-controlled\nuntil the 26- and 52-week time points. The primary efficacy endpoint of the\ntrial will be the change from baseline in the Positive and Negative Syndrome\nScale (PANSS) scores at 12 weeks. Newron expects to announce results from the\n12-week primary endpoint assessment in Q1 2027.\n\nENIGMA-TRS 2 is taking place at centers in the U.S. and selected additional\ncountries with the same screening procedure as the ENIGMA-TRS 1 trial.\nENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized,\ndouble-blind, placebo-controlled Phase 3 study, designed to evaluate the\nefficacy, tolerability, and safety of the 15mg BID dose of evenamide compared\nto placebo. In December 2025, ENIGMA-TRS 2 was initiated in the U.S.,\nfollowing approvals from the U.S, Food and Drug Administration (FDA) and the\nInstitutional Review Board (IRB). The efficacy and safety analysis will be\nperformed at the 12-week point following successful completion of the study.\nOn April 29, 2026, Newron reported a hold by the FDA on the enrollment of new\npatients in the U.S. sites of the study. While U.S. patients entered\nscreening, no U.S. patients have been dosed with evenamide, in the study.\n\nAbout Newron Pharmaceuticals\nNewron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the\ndevelopment of innovative therapies for patients with diseases of the central\nand peripheral nervous system. Headquartered in Bresso near Milan, Italy, the\nCompany has a strong track record of advancing neuroscience-based treatments\nfrom discovery to market. Newron’s lead compound, evenamide, is a\nfirst-in-class glutamate modulator and has the potential to be the first\nadd-on therapy for treatment-resistant schizophrenia (TRS) and for poorly\nresponding patients with schizophrenia. Evenamide is currently developed in\nthe global pivotal ENIGMA-TRS Phase 3 development program. Clinical trial\nresults to date demonstrate the benefits of this drug candidate in TRS as well\nas poorly responding patient population, with significant improvements across\nkey efficacy measures increasing over time, as well as a favorable safety\nprofile, which is uncommon for available antipsychotic medications. Newron has\nsigned development and commercialization agreements for evenamide with EA\nPharma (a subsidiary of Eisai) for Japan and other Asian territories, as well\nas Myung In Pharm for South Korea. Newron’s first marketed product,\nXadago®/safinamide has received marketing authorization for the treatment of\nParkinson’s disease in the European Union, Switzerland, the UK, the USA,\nAustralia, Canada, Latin America, Israel, the United Arab Emirates, Japan and\nSouth Korea. The product is commercialized by Newron’s partner Zambon, with\nSupernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika\nresponsible for development and commercialization in Japan and other key Asian\nterritories. For more information, please visit: https://www.newron.com and\nconnect with us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=oOfKhtb6xUEUGk4NO4g5teC8iZQ5sMHY82rknr6-_szuB03pkfDpz6rK1UvOCpCRrh1wcg9QaswgH-tRFTMpRo1DVpuelOCBOSYUGfN-57A5MvXGJOz0Fdc2CRqxRT94).\n\nFor more information, please contact:\n\nNewron\nStefan Weber – CEO; +39 02 6103 46 26, pr@newron.com\n\nUK/Europe\nSimon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20\n3727 1000, SCnewron@fticonsulting.com\n\nSwitzerland\nValentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch\n\nGermany/Europe\nAnne Hennecke / Maximilian Schur, MC Services; +49 211 52925227,\nnewron@mc-services.eu\n\nUSA\nJohn Fraunces, LifeSci Advisors; +1 917 355 2395,\njfraunces@lifesciadvisors.com\n\nImportant Notices\nThis document contains forward-looking statements, including (without\nlimitation) about (1) Newron’s ability to develop and expand its business,\nsuccessfully complete development of its current product candidates, the\ntiming of commencement of various clinical trials and receipt of data and\ncurrent and future collaborations for the development and commercialization of\nits product candidates, (2) the market for drugs to treat CNS diseases and\npain conditions, (3) Newron’s financial resources, and (4) assumptions\nunderlying any such statements. In some cases, these statements and\nassumptions can be identified by the fact that they use words such as\n“will”, “anticipate”, “estimate”, “expect”, “project”,\n“intend”, “plan”, “believe”, “target”, and other words and\nterms of similar meaning. All statements, other than historical facts,\ncontained herein regarding Newron's strategy, goals, plans, future financial\nposition, projected revenues and costs and prospects are forward-looking\nstatements. By their very nature, such statements and assumptions involve\ninherent risks and uncertainties, both general and specific, and risks exist\nthat predictions, forecasts, projections and other outcomes described, assumed\nor implied therein will not be achieved. Future events and actual results\ncould differ materially from those set out in, contemplated by or underlying\nthe forward-looking statements due to a number of important factors. These\nfactors include (without limitation) (1) uncertainties in the discovery,\ndevelopment or marketing of products, including without limitation\ndifficulties in enrolling clinical trials, negative results of clinical trials\nor research projects or unexpected side effects, (2) delay or inability in\nobtaining regulatory approvals or bringing products to market, (3) future\nmarket acceptance of products, (4) loss of or inability to obtain adequate\nprotection for intellectual property rights, (5) inability to raise additional\nfunds, (6) success of existing and entry into future collaborations and\nlicensing agreements, (7) litigation, (8) loss of key executive or other\nemployees, (9) adverse publicity and news coverage, and (10) competition,\nregulatory, legislative and judicial developments or changes in market and/or\noverall economic conditions. Newron may not actually achieve the plans,\nintentions or expectations disclosed in forward-looking statements and\nassumptions underlying any such statements may prove wrong. Investors should\ntherefore not place undue reliance on them. There can be no assurance that\nactual results of Newron's research programs, development activities,\ncommercialization plans, collaborations and operations will not differ\nmaterially from the expectations set out in such forward-looking statements or\nunderlying assumptions. Newron does not undertake any obligation to publicly\nupdate or revise forward-looking statements except as may be required by\napplicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock\nExchange where the shares of Newron are listed. This document does not contain\nor constitute an offer or invitation to purchase or subscribe for any\nsecurities of Newron and no part of it shall form the basis of or be relied\nupon in connection with any contract or commitment whatsoever.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/3253ee21-b5d3-40be-a6a4-4e7dac9e66e5)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX4pZTpb-20261008","title":"Newron Provides Update on FDA Clinical Hold and Phase 3 ENIGMA-TRS Development Program","author":"Globe Newswire","ticker":"NWRN","created":"2026-10-08T11:00:00.890Z","tickers":["NWRN"],"exchange":"","article_body":"Management call today at 3.30 pm CEST\n\nNewron received the anticipated FDA written communication on clinical hold at\nU.S. study centers and is reviewing feedback and preparing its response\n\nENIGMA-TRS 1 enrollment expected to be completed by mid-October; topline\n12-week data expected in Q1 2027\n\nENIGMA-TRS 2 enrollment continuing outside the U.S., with additional clinical\nsites being added as planned\n\nFDA clinical hold remains in place at U.S. study centers; Newron intends to\nrespond upon thorough review and analysis of FDA feedback\n\nMILAN and MORRISTOWN, N.J., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Newron\nPharmaceuticals S.p.A.\n(https://www.globenewswire.com/Tracker?data=eE15eoD2b79889NmDhroAvuMmlFoHNpWxdgZJRHGcg9Z_LrQMh5Zx_3hv_lXW5qW89vmAsv85FvnrvymsKBo0bloGlndJg-tpqJtLYlad_I=)\n(“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on\nthe development of novel therapies for patients with diseases of the central\nand peripheral nervous system, today announced that, further to its press\nrelease on September 25 2026, the Company has in the meantime received written\ncommunication from the U.S. Food and Drug Administration (FDA) regarding the\nclinical hold at U.S. study centers in its Phase 3 ENIGMA-TRS 2 study with\nevenamide. Newron is conducting a thorough review of the FDA’s feedback and\nthe available data and intends to submit its response upon completion.\n\nNewron continues to advance the Phase 3 ENIGMA-TRS development program.\nENIGMA-TRS 1 enrollment is expected to be completed by mid-October, with\ntopline 12-week data expected in Q1 2027. ENIGMA-TRS 2 enrollment continues\noutside the U.S. Additional clinical sites are being added as planned.\n\nFDA Clinical Hold and ENIGMA-TRS Program Update\n\nThe FDA’s concern relates to the known risk that certain members of the\nclass of sodium channel blockers may trigger arrhythmias which in turn can\nlead to serious cardiovascular events or seizures. Evenamide is a glutamate\nmodulator via its action as a selective voltage-gated sodium channel blocker.\n\nIn its written communication, the FDA notes four deaths among patients treated\nwith evenamide across all clinical studies with evenamide to date, compared\nwith one death among patients receiving placebo. Of the four deaths among\npatients receiving evenamide, three were considered unrelated to evenamide by\nthe study investigators, while one was considered “possibly related”\nbecause two autopsies could not identify a definitive cause of death. The four\ndeaths have been characterized by the FDA as a potential safety signal based\non the possibility of a fatal arrhythmic mechanism, which cannot be\ndefinitively excluded through post hoc adjudication. Evenamide is also known\nto result in a very small shortening of the QTc interval on an\nelectrocardiogram (ECG). Unlike QTc prolongation, there is no established risk\nor intervention threshold for QTc shortening, and a standard screening ECG\ndoes not reliably exclude latent sodium-channel disorders in asymptomatic\npatients.\n\nNewron is reviewing the FDA’s feedback and the full body of safety data\ngenerated across the evenamide development program, which includes more than\n10,000 ECGs from approximately 700 evenamide-treated subjects and input from\nindependent cardiac electrophysiologists. Newron has not observed a pattern of\ncardiac abnormalities or arrhythmias in the preclinical and clinical safety\ndata generated with evenamide to date. This includes a thorough QT study and\nmore than 5,000 ECGs from over 700 patients with schizophrenia. As part of its\nresponse, Newron is also evaluating additional cardiac screening and\nmonitoring measures for ENIGMA-TRS 2.\n\n“We remain confident in the ENIGMA-TRS studies and encouraged by the\nprogram’s progress. Our belief in the potential of evenamide and its novel\nmechanism for patients with treatment-resistant schizophrenia remains\nstrong,” said Ravi Anand, MD, Chief Medical Officer of Newron. “Patient\nsafety is our utmost priority. Our team is working with high commitment to\ncomplete a thorough review of the FDA’s feedback and the available data, and\nto submit our response upon its completion. Our assessment is supported by the\nsubstantial body of preclinical and clinical safety data generated with\nevenamide. To date, we have not observed a pattern of cardiac abnormalities or\narrhythmias. The four deaths among patients treated with evenamide represent\nan incidence of 0.56%, compared with one death and an incidence of 0.27% among\npatients receiving placebo. When adjusted for duration of treatment, the\nmortality rate was 1.31 per 100 patient-years for evenamide compared with 1.81\nper 100 patient-years for placebo.”\n\nProfessor Dr. Peter Falkai, Chair Department of Psychiatry and Psychotherapy,\nLMU University of Munich, stated: “Schizophrenia is a tragic disease that\naffects patients in the teenage (males) and early twenties (females) and has a\ndevastating effect on their lives. In addition to multiple episodes of\npsychosis and hospitalization, patients need to take antipsychotic medication\nwith debilitating side-effects that makes them suffer from cardiac, hormonal,\nmetabolic and motor disorders. Furthermore, schizophrenia reduces\nlife-expectancy by about 10 years. TRS, a more severe form of the disease in\nwhich patients do not respond to any medication, reduces longevity by about 20\nyears.”\n\nInvestor Update Conference Call\nManagement will provide a brief update on the FDA clinical hold and ENIGMA-TRS\ndevelopment program. The call will be recorded and take place today at 3.30 pm\nCEST.\n\nThe access details:\n\n Switzerland / Europe United Kingdom United States  +41 (0) 58 310 50 00 +44 (0) 203 059 58 63 +1 (1) 631 570 56 13  \n                                                                                                                     \n\nOther international numbers available here.\n(https://www.globenewswire.com/Tracker?data=eUVUElE9sEmPmsNCp-HL7DE5ZfTQnyPpVyZjmnDC3nYdBIeDP-efuYoiFiVCWKVnbMpEyB9MN2s6Z66xw2yUG6cDO7LHdynWs1hS_E0BmUWXnHZF-0cu-Wv18hvXGXu9TY7Ba9pJjOjzBbfOKa3A-w==)\n\nAbout ENIGMA-TRS \nENIGMA-TRS 1 is an ongoing, international, 52-week, randomized, double-blind,\nplacebo-controlled Phase 3 study evaluating the efficacy, tolerability, and\nsafety of the 15mg BID and 30mg BID therapeutic doses of evenamide compared to\nplacebo. Patients on second-generation antipsychotics, including clozapine,\nwill meet Treatment Response and Resistance Psychosis international consensus\ncriteria for TRS. The study is expected to have enrolled at least 600 patients\nin the study by mid-October 2026, at study centers in 20 countries in Europe,\nAsia, Latin America, and Canada.\n\nThe primary assessment of efficacy and safety of ENIGMA-TRS 1 will be\nperformed 12 weeks after randomization to treatment. Following this initial\nperiod, the study will continue to be double-blind and placebo-controlled\nuntil the 26- and 52-week time points. The primary efficacy endpoint of the\ntrial will be the change from baseline in the Positive and Negative Syndrome\nScale (PANSS) scores at 12 weeks. Newron expects to announce results from the\n12-week primary endpoint assessment in Q1 2027.\n\nENIGMA-TRS 2 is taking place at centers in the U.S. and selected additional\ncountries with the same screening procedure as the ENIGMA-TRS 1 trial.\nENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized,\ndouble-blind, placebo-controlled Phase 3 study, designed to evaluate the\nefficacy, tolerability, and safety of the 15mg BID dose of evenamide compared\nto placebo. In December 2025, ENIGMA-TRS 2 was initiated in the U.S.,\nfollowing approvals from the U.S, Food and Drug Administration (FDA) and the\nInstitutional Review Board (IRB). The efficacy and safety analysis will be\nperformed at the 12-week point following successful completion of the study.\nOn April 29, 2026, Newron reported a hold by the FDA on the enrollment of new\npatients in the U.S. sites of the study. While U.S. patients entered\nscreening, no U.S. patients have been dosed with evenamide, in the study.\n\nAbout Newron Pharmaceuticals\nNewron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the\ndevelopment of innovative therapies for patients with diseases of the central\nand peripheral nervous system. Headquartered in Bresso near Milan, Italy, the\nCompany has a strong track record of advancing neuroscience-based treatments\nfrom discovery to market. Newron’s lead compound, evenamide, is a\nfirst-in-class glutamate modulator and has the potential to be the first\nadd-on therapy for treatment-resistant schizophrenia (TRS) and for poorly\nresponding patients with schizophrenia. Evenamide is currently developed in\nthe global pivotal ENIGMA-TRS Phase 3 development program. Clinical trial\nresults to date demonstrate the benefits of this drug candidate in TRS as well\nas poorly responding patient population, with significant improvements across\nkey efficacy measures increasing over time, as well as a favorable safety\nprofile, which is uncommon for available antipsychotic medications. Newron has\nsigned development and commercialization agreements for evenamide with EA\nPharma (a subsidiary of Eisai) for Japan and other Asian territories, as well\nas Myung In Pharm for South Korea. Newron’s first marketed product,\nXadago®/safinamide has received marketing authorization for the treatment of\nParkinson’s disease in the European Union, Switzerland, the UK, the USA,\nAustralia, Canada, Latin America, Israel, the United Arab Emirates, Japan and\nSouth Korea. The product is commercialized by Newron’s partner Zambon, with\nSupernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika\nresponsible for development and commercialization in Japan and other key Asian\nterritories. For more information, please visit: https://www.newron.com and\nconnect with us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=oOfKhtb6xUEUGk4NO4g5teC8iZQ5sMHY82rknr6-_szuB03pkfDpz6rK1UvOCpCRrh1wcg9QaswgH-tRFTMpRo1DVpuelOCBOSYUGfN-57A5MvXGJOz0Fdc2CRqxRT94).\n\nFor more information, please contact:\n\nNewron\nStefan Weber – CEO; +39 02 6103 46 26, pr@newron.com\n\nUK/Europe\nSimon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20\n3727 1000, SCnewron@fticonsulting.com\n\nSwitzerland\nValentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch\n\nGermany/Europe\nAnne Hennecke / Maximilian Schur, MC Services; +49 211 52925227,\nnewron@mc-services.eu\n\nUSA\nJohn Fraunces, LifeSci Advisors; +1 917 355 2395,\njfraunces@lifesciadvisors.com\n\nImportant Notices\nThis document contains forward-looking statements, including (without\nlimitation) about (1) Newron’s ability to develop and expand its business,\nsuccessfully complete development of its current product candidates, the\ntiming of commencement of various clinical trials and receipt of data and\ncurrent and future collaborations for the development and commercialization of\nits product candidates, (2) the market for drugs to treat CNS diseases and\npain conditions, (3) Newron’s financial resources, and (4) assumptions\nunderlying any such statements. In some cases, these statements and\nassumptions can be identified by the fact that they use words such as\n“will”, “anticipate”, “estimate”, “expect”, “project”,\n“intend”, “plan”, “believe”, “target”, and other words and\nterms of similar meaning. All statements, other than historical facts,\ncontained herein regarding Newron's strategy, goals, plans, future financial\nposition, projected revenues and costs and prospects are forward-looking\nstatements. By their very nature, such statements and assumptions involve\ninherent risks and uncertainties, both general and specific, and risks exist\nthat predictions, forecasts, projections and other outcomes described, assumed\nor implied therein will not be achieved. Future events and actual results\ncould differ materially from those set out in, contemplated by or underlying\nthe forward-looking statements due to a number of important factors. These\nfactors include (without limitation) (1) uncertainties in the discovery,\ndevelopment or marketing of products, including without limitation\ndifficulties in enrolling clinical trials, negative results of clinical trials\nor research projects or unexpected side effects, (2) delay or inability in\nobtaining regulatory approvals or bringing products to market, (3) future\nmarket acceptance of products, (4) loss of or inability to obtain adequate\nprotection for intellectual property rights, (5) inability to raise additional\nfunds, (6) success of existing and entry into future collaborations and\nlicensing agreements, (7) litigation, (8) loss of key executive or other\nemployees, (9) adverse publicity and news coverage, and (10) competition,\nregulatory, legislative and judicial developments or changes in market and/or\noverall economic conditions. Newron may not actually achieve the plans,\nintentions or expectations disclosed in forward-looking statements and\nassumptions underlying any such statements may prove wrong. Investors should\ntherefore not place undue reliance on them. There can be no assurance that\nactual results of Newron's research programs, development activities,\ncommercialization plans, collaborations and operations will not differ\nmaterially from the expectations set out in such forward-looking statements or\nunderlying assumptions. Newron does not undertake any obligation to publicly\nupdate or revise forward-looking statements except as may be required by\napplicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock\nExchange where the shares of Newron are listed. This document does not contain\nor constitute an offer or invitation to purchase or subscribe for any\nsecurities of Newron and no part of it shall form the basis of or be relied\nupon in connection with any contract or commitment whatsoever.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/3253ee21-b5d3-40be-a6a4-4e7dac9e66e5)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-08T11:00:00.966301367Z","server_sent_at_ms":1791457200966},"received_at":"2026-10-08T11:00:01.018Z","source_url":null},"analysis":{"id":"152463","press_release_id":"164026","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["FDA clinical hold persists at U.S. sites of pivotal Phase 3 ENIGMA-TRS 2 study","FDA characterizes four deaths on evenamide (vs one placebo) as potential safety signal with possible fatal arrhythmic mechanism","evenamide shortens QTc interval; no established screening threshold to exclude latent sodium-channel disorders","response to FDA has no stated timeline; U.S. enrollment/dosing paused"],"eventType":"clinical_trial","narrative":"Newron received the FDA's written communication on the clinical hold at U.S. study centers of the Phase 3 ENIGMA-TRS 2 study with evenamide and is preparing its response; the hold remains in place.\n\nThe FDA flagged four deaths among evenamide-treated patients versus one on placebo as a potential safety signal, citing a possible fatal arrhythmic mechanism that cannot be definitively excluded. Newron counters that three of the four were deemed unrelated by investigators and that adjusted mortality was lower on evenamide (1.31 vs 1.81 per 100 patient-years).\n\nThe program continues ex-U.S.: ENIGMA-TRS 1 enrollment should finish by mid-October with topline 12-week data in Q1 2027, and ENIGMA-TRS 2 enrollment proceeds outside the U.S.\n\nThe hold at U.S. sites of the pivotal study creates a material regulatory overhang on evenamide, the company's lead and first-in-class asset for treatment-resistant schizophrenia.","sentiment":"bearish","agentHooks":{"shouldPost":true,"suggestedAngle":"FDA death-related safety signal keeps evenamide's pivotal U.S. study on hold — binary risk ahead of Q1 2027 topline data."},"keyFigures":{"drugName":"evenamide","phaseOfTrial":"Phase 3","customDimensions":{"ecgs_analyzed":"more than 10,000 ECGs from approximately 700 evenamide-treated subjects","deaths_placebo":1,"deaths_evenamide":4,"enigma_trs1_data":"topline 12-week data expected Q1 2027","incidence_placebo":"0.27%","incidence_evenamide":"0.56%","clinical_hold_status":"FDA clinical hold remains at U.S. study centers; written communication received and under review","enigma_trs1_enrollment":"at least 600 patients by mid-October 2026","mortality_rate_placebo":"1.81 per 100 patient-years","mortality_rate_evenamide":"1.31 per 100 patient-years","enigma_trs2_target_enrollment":"at least 400 patients"}},"quotedText":"The four deaths have been characterized by the FDA as a potential safety signal based on the possibility of a fatal arrhythmic mechanism, which cannot be definitively excluded through post hoc adjudication.","namedEntities":{"people":[{"name":"Ravi Anand, MD","role":"Chief Medical Officer"},{"name":"Professor Dr. Peter Falkai","role":"Chair, Department of Psychiatry and Psychotherapy, LMU University of Munich"},{"name":"Stefan Weber","role":"CEO"}],"products":["evenamide","Xadago (safinamide)"],"companies":[{"name":"Newron Pharmaceuticals S.p.A.","ticker":"NWRN","relationship":"filer"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"Zambon","relationship":"partner"},{"name":"Supernus Pharmaceuticals","relationship":"partner"},{"name":"Meiji Seika","relationship":"partner"},{"name":"EA Pharma (subsidiary of Eisai)","relationship":"partner"},{"name":"Myung In Pharm","relationship":"partner"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"FDA clinical hold remains in place at U.S. sites of the pivotal Phase 3 ENIGMA-TRS 2 study, and the FDA flagged a potential safety signal — four deaths on evenamide vs one on placebo with a possible fatal arrhythmic mechanism. This threatens the company's lead asset timeline and approval path."},"tickerRelevance":{"others":[],"primary":"NWRN"},"globalImportance":45,"audienceRelevance":25,"eventTypeSecondary":["regulatory"],"importanceComponents":{"tickerTier":"small-cap (SIX-listed European biotech)","eventGravity":"FDA clinical hold with potential mortality safety signal on lead asset","sectorWeight":"biotech regulatory binary","householdBrandBoost":0,"retailFavoriteBoost":0}},"event_type":"clinical_trial","event_type_secondary":["regulatory"],"sentiment":"bearish","material_impact_score":4,"narrative":"Newron received the FDA's written communication on the clinical hold at U.S. study centers of the Phase 3 ENIGMA-TRS 2 study with evenamide and is preparing its response; the hold remains in place.\n\nThe FDA flagged four deaths among evenamide-treated patients versus one on placebo as a potential safety signal, citing a possible fatal arrhythmic mechanism that cannot be definitively excluded. Newron counters that three of the four were deemed unrelated by investigators and that adjusted mortality was lower on evenamide (1.31 vs 1.81 per 100 patient-years).\n\nThe program continues ex-U.S.: ENIGMA-TRS 1 enrollment should finish by mid-October with topline 12-week data in Q1 2027, and ENIGMA-TRS 2 enrollment proceeds outside the U.S.\n\nThe hold at U.S. sites of the pivotal study creates a material regulatory overhang on evenamide, the company's lead and first-in-class asset for treatment-resistant schizophrenia.","key_figures":{"drugName":"evenamide","phaseOfTrial":"Phase 3","customDimensions":{"ecgs_analyzed":"more than 10,000 ECGs from approximately 700 evenamide-treated subjects","deaths_placebo":1,"deaths_evenamide":4,"enigma_trs1_data":"topline 12-week data expected Q1 2027","incidence_placebo":"0.27%","incidence_evenamide":"0.56%","clinical_hold_status":"FDA clinical hold remains at U.S. study centers; written communication received and under review","enigma_trs1_enrollment":"at least 600 patients by mid-October 2026","mortality_rate_placebo":"1.81 per 100 patient-years","mortality_rate_evenamide":"1.31 per 100 patient-years","enigma_trs2_target_enrollment":"at least 400 patients"}},"named_entities":{"people":[{"name":"Ravi Anand, MD","role":"Chief Medical Officer"},{"name":"Professor Dr. Peter Falkai","role":"Chair, Department of Psychiatry and Psychotherapy, LMU University of Munich"},{"name":"Stefan Weber","role":"CEO"}],"products":["evenamide","Xadago (safinamide)"],"companies":[{"name":"Newron Pharmaceuticals S.p.A.","ticker":"NWRN","relationship":"filer"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"Zambon","relationship":"partner"},{"name":"Supernus Pharmaceuticals","relationship":"partner"},{"name":"Meiji Seika","relationship":"partner"},{"name":"EA Pharma (subsidiary of Eisai)","relationship":"partner"},{"name":"Myung In Pharm","relationship":"partner"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-08T11:00:16.207Z","global_importance":45,"audience_relevance":25,"importance_components":{"tickerTier":"small-cap (SIX-listed European biotech)","eventGravity":"FDA clinical hold with potential mortality safety signal on lead asset","sectorWeight":"biotech regulatory binary","householdBrandBoost":0,"retailFavoriteBoost":0}},"durationMs":8578,"modelName":"glm-5.3-flashx"}}