Newron - Pagina 96
Mercati alle prese con tre nodi da qui a fine anno, focus sugli asset meglio posizionati in ottica rialzo tassi
Il mercato del lavoro, le catene di approvvigionamento e la Cina. Sono questi i tre fattori da tener ben monitorati in questo momento dell?anno per superare senza particolari problemi la …
Titolo Telecom Italia sottovalutato? Mercato non dà retta a Gubitosi e in Borsa la tlc rivede gli inferi di ottobre 2020
Per Telecom Italia si sta materializzando un altro autunno da dimenticare in Borsa e anche le parole di Luigi Gubitosi non stanno riuscendo a dare fiato al titolo che segna …
Nasce il Mib ESG: funzionamento dell’indice e lista dei 40 titoli più sostenibili di Piazza Affari. Non mancano sorprese e differenze vs Ftse Mib
Prende vita oggi il primo indice Esg sulle blue chip di Piazza Affari. Il nuovo indice Mib ESG, annunciato oggi da Euronext, è infatti il primo indice Esg (Environmental, Social …
Tutti gli articoli
Tutti gli articoli Tutte le notizie

  1. #951

    Data Registrazione
    Aug 2007
    Messaggi
    918
    Mentioned
    0 Post(s)
    Quoted
    152 Post(s)
    Potenza rep
    17276963
    Newron announces results of explanatory studies with evenamide in healthy volunteers and patients with schizophrenia

    Primary objective of safety of evenamide met on all safety variables for study 010 in healthy volunteers and study 008 in patients with schizophrenia

    Additional safety and efficacy study 008A in therapeutic dose (30 mg BID) to start in April 2021

    Milan, Italy and Morristown, NJ, USA, April 1, 2021 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced initial results from two short-term explanatory studies in evenamide: study 010 in healthy volunteers and study 008 in patients with schizophrenia.

    Results from study 010, a four-week, single dose, cross-over Thorough QT (TQT) study in 56 healthy volunteers, designed to evaluate the effects of evenamide (30 mg and 60 mg) compared with placebo and moxifloxacin 400 mg on the QT segment specifically, and on the electrocardiogram (ECG) generally, was requested by the US Food and Drug Administration (FDA) and under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The results indicate that evenamide was devoid of any QTcF prolongation compared to placebo (indicating lack of any increased risk of arrythmia), while moxifloxacin was associated with a 17.3 ms median maximum increase suggestive of clinically significant risk of arrhythmia. These results strongly suggest that evenamide does not increase a patient’s risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.

    Study 008, a four-week, randomized, double-blind placebo-controlled study was designed to primarily evaluate the safety, tolerability, and electroencephalogram (EEG) effects of two fixed doses of evenamide (7.5 mg and 15 mg BID). The study was requested by the FDA to address questions which arose from a study of evenamide in rats, and central nervous system (CNS) events observed following high-dose administration of evenamide in dogs. The study was performed in 138 outpatients with chronic schizophrenia, receiving treatment with a second-generation atypical antipsychotic at study centers in the United States and India.

    Over 95% of the patients completed study 008. No patient on evenamide discontinued from the study due to adverse events, and there were no significant adverse events relating to evenamide. No symptoms were observed suggestive of severe CNS events, symptoms/signs of seizures, EEG diagnosis of seizure like activity, or cardiac events in patients with evenamide. There were no differences in laboratory, ECG or vital signs abnormalities between evenamide and placebo-treated patients. The most frequent adverse events observed were related to CNS, gastrointestinal disorders, psychiatric disorders, metabolism and nutrition disorders and laboratory investigations. The most frequent adverse events reported (greater than 5%) were headache and somnolence, which were equally distributed between evenamide and placebo.

    Study 008 was designed to primarily assess safety and was not powered to demonstrate efficacy. The results, as expected, indicated that the 7.5 mg BID was a “no-effect” dose, which will not be investigated further. The 15 mg BID dose produced a higher magnitude response on the total PANSS than 7.5 mg BID, but this was not statistically significant when compared to placebo.The safety of the 30 mg BID (designated as the therapeutic dose) will be assessed in a planned additional study 008A in patients with schizophrenia, which is required in order to fully comply with the FDA’s original request prior to starting the planned phase III program. Study 008A will be initiated in the next days, with results expected in the second half of 2021.

    Ravi Anand, MD, Newron’s CMO, commented: “The results of study 010 are of far-reaching importance as they indicate that evenamide, even at doses of 60 mg (twice the therapeutic dose), is devoid of any arrhythmic effect and thus can be safely added to any other antipsychotic. Furthermore, the safety data, specifically, the lack of any systemic pattern of adverse effects relating to the CNS (including EEG) indicate that the drug is safe at the doses investigated. We will now evaluate the safety of the 30 mg (BID) dose, the expected therapeutic dose, in patients with schizophrenia, in study 008A and plan for the initiating of our phase III program shortly after.”

    The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment-resistant schizophrenia. The program will commence once study 008A results are available.

    Newron is currently evaluating potential options for partnering/co-developing the further development of evenamide.

    About evenamide
    Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. The compound is an orally available New Chemical Entity that specifically targets voltage-gated sodium channels for the treatment of schizophrenia. Evenamide originates from Newron’s ion channel program and has a unique mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. It normalizes glutamate release induced by aberrant sodium channel activity. In a Phase IIa clinical study, Newron demonstrated evenamide’s evidence of efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. The study also indicated that evenamide is devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics.

  2. #952
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    7,541
    Mentioned
    10 Post(s)
    Quoted
    1296 Post(s)
    Potenza rep
    42949686
    Da quando è uscita la notizia sull'Evenamide, in pochi giorni siamo passati da 2,90 a 2,50; davvero un cattivo segno per il futuro della molecola.

  3. #953
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    7,541
    Mentioned
    10 Post(s)
    Quoted
    1296 Post(s)
    Potenza rep
    42949686
    E siamo a 2,33 chf; a quanto pare anche l'Evenamide non funziona.

  4. #954
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    7,541
    Mentioned
    10 Post(s)
    Quoted
    1296 Post(s)
    Potenza rep
    42949686
    Ora siamo a 2,50 chf. Ma questo Evenamide verrà mai portato in fase clinica III e se si ha delle possibilità di essere approvato ?

  5. #955

    Data Registrazione
    Aug 2007
    Messaggi
    918
    Mentioned
    0 Post(s)
    Quoted
    152 Post(s)
    Potenza rep
    17276963
    Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that it received a Paragraph IV Notice Letter regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents.

    Newron is reviewing the details of this Notice Letter and will respond as appropriate to protect its intellectual property rights relating to Xadago® (safinamide) tablets.

    Xadago® (safinamide) tablets are currently protected by three patents listed in the FDA’s Approved Drugs Product List (Orange Book) that expire no earlier than 2026.

  6. #956
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    7,541
    Mentioned
    10 Post(s)
    Quoted
    1296 Post(s)
    Potenza rep
    42949686
    Newron avvia il primo studio potenzialmente registrativo con evenamide in pazienti con schizofrenia
    06. set 2021
    Annuncio ad hoc ai sensi dell'articolo 53 del Regolamento di quotazione SEI


    Evenamide ha il potenziale per essere la prima terapia aggiuntiva per i pazienti con sintomi positivi di schizofrenia

    Studio di quattro settimane, in doppio cieco, controllato con placebo per valutare la sicurezza e l'efficacia della dose terapeutica (30 mg BID)

    Minimo di 200 pazienti da arruolare presso centri studi in Europa, Asia e America Latina

    Il meccanismo d'azione di inibizione glutamatergica di Evenamide offre un'opzione terapeutica innovativa ai pazienti che non beneficiano degli attuali trattamenti antipsicotici



    Milano, Italia e Morristown, NJ, USA, 6 settembre 2021, ore 07:00 CEST – Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), azienda biofarmaceutica focalizzata sullo sviluppo di nuove terapie per pazienti con patologie del sistema nervoso centrale e periferico, ha annunciato oggi l'avvio dello Studio 008A, il primo studio potenzialmente registrativo con evenamide in pazienti con schizofrenia.

    Lo studio 008A, uno studio internazionale di quattro settimane, randomizzato, in doppio cieco controllato con placebo, è progettato per valutare l'efficacia, la tollerabilità e la sicurezza (compresi gli effetti sull'elettroencefalogramma (EEG)) della dose terapeutica BID da 30 mg di evenamide in pazienti con schizofrenia cronica, attualmente in trattamento con un antipsicotico di seconda generazione. Newron prevede di randomizzare almeno 200 pazienti nei centri di studio in Europa, Asia e America Latina. I risultati dello studio sono attesi entro il Q4 2022.

    Questo studio fa parte del programma di sperimentazione clinica di fase III dell'evenamide di Newron che si rivolge a pazienti con schizofrenia che sperimentano un peggioramento della psicosi su dosi terapeutiche di antipsicotici atipici, nonché a pazienti resistenti al trattamento.

    Ravi Anand, MD, CMO di Newron, ha commentato: "Evenamide ha dimostrato di essere sicura negli studi che hanno trattato più di 300 volontari e pazienti sani a dosi fino a 60 mg. Lo studio 008A valuterà ora l'efficacia, la tollerabilità e la sicurezza della dose terapeutica di 30 mg BID. In caso di successo, Newron ritiene che lo studio si qualificherebbe come il primo studio (pivotal) adeguato e ben controllato con evenamide in pazienti con schizofrenia che sono responder inadeguati agli antipsicotici. Evenamide sarebbe attualmente la prima terapia aggiuntiva approvata per il trattamento di pazienti con sintomi positivi di schizofrenia, e il suo meccanismo d'azione unico di inibizione glutamatergica offre un'opzione terapeutica veramente innovativa a quei pazienti che non stanno beneficiando dei loro attuali antipsicotici".

    Newron sta attualmente valutando potenziali opzioni per collaborare/co-sviluppare l'ulteriore sviluppo di evenamide.

  7. #957

    Data Registrazione
    Aug 2007
    Messaggi
    918
    Mentioned
    0 Post(s)
    Quoted
    152 Post(s)
    Potenza rep
    17276963
    Newron Receives Fourth Tranche from Financing Agreement with European Investment Bank (EIB)



    Milan, Italy – September 6, 2021, 5.45 pm CEST – Newron Pharmaceutical S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announces that it has received Tranche 4 under its financing agreement with the European Investment Bank (EIB) that was signed in October 2018 and comprises up to EUR 40 million, subject to achieving a set of agreed performance criteria. The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe. Tranche 4 consists of EUR 7.5 million and will primarily be used to support the Company’s development programs in diseases of the central nervous system. The first three tranches of the loan totaling EUR 25 million were received by Newron in 2019 and 2020.

    In connection with Tranche 4, EIB has received warrants entitling it to purchase up to 151,344 ordinary shares of Newron at an exercise price of EUR 9.25 per share.

  8. #958
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    7,541
    Mentioned
    10 Post(s)
    Quoted
    1296 Post(s)
    Potenza rep
    42949686
    Newron announces Half-Year 2021 results
    Sep 16 2021
    Ad hoc announcement pursuant to Art. 53 LR

    Milan, Italy, September 16, 2021, 07:00 am CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its operational highlights and financial results for the half-year ended June 30, 2021.

    Highlights:

    Evenamide (Schizophrenia)

    -The primary objective of two short-term explanatory studies of evenamide was met on all safety variables: study 010, in healthy volunteers, and study 008, in patients with schizophrenia
    -Post-period, Newron initiated study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia, results from which are expected by Q4 2022
    -Newron continues to evaluate strategic commercial and development partnering options for evenamide
    Xadago®/safinamide (Parkinson’s disease)

    -Newron signed an agreement with its partner Zambon to commence a potentially pivotal study with safinamide in Parkinson’s disease patients with levodopa-induced dyskinesia (PD LID)
    -Newron is currently working on finalizing the design of the study with international clinical experts and regulatory authorities and intends to initiate the study in Q1 2022
    -Newron and its partners Zambon and Supernus are responding appropriately to protect the intellectual property rights relating to Xadago®/safinamide in the US, following some Paragraph IV Notice Letters regarding Abbreviated New Drug Applications that have been submitted by generic manufacturers
    Corporate

    -Newron is in the process of conducting value assessments on several potential opportunities to broaden its pipeline of treatments for central and peripheral nervous system diseases
    -Post-period, Newron received a fourth tranche of EUR 7.5 million under its financing agreement with the European Investment Bank (EIB)
    Stefan Weber, CEO of Newron, commented:

    “As we move forward into the remainder of 2021, we are pleased with the progress we are making with our innovative products. In particular, we look forward to advancing our potentially pivotal studies with evenamide in patients with schizophrenia and with safinamide in PD LID. We are evaluating opportunities to broaden our pipeline of treatments for central and peripheral nervous system diseases, as well as exploring opportunities to partner, where appropriate. Newron’s total available cash resources, including the EIB funds not yet drawn down, in addition to its royalty income and Italian R&D tax credits, will fund our planned development programs and operations well into 2023.”

    Evenamide

    In April, Newron announced encouraging results from two short-term explanatory studies in evenamide: study 010 in 56 healthy volunteers, and study 008 in 138 outpatients with chronic schizophrenia, receiving treatment with a second-generation atypical antipsychotic. These promising results showed that evenamide is devoid of any arrhythmic effect, a risk generally associated with antipsychotics, even at twice the therapeutic dose, and can be safely added to any other antipsychotic. The results also demonstrated that the drug is safe at all doses investigated, due to the lack of any systemic pattern of adverse effects relating to the central nervous system.

    Based on this encouraging data and supported by the pre-clinical results published last year confirming the absence of toxicity, Newron, on September 6, 2021, initiated study 008A, the first potentially pivotal study with evenamide in patients with chronic schizophrenia. Study 008A, a four-week, randomized, double-blind placebo-controlled international study, is designed to evaluate the efficacy, tolerability, and safety – including electroencephalography (EEG) effects – of the 30mg BID therapeutic dose of evenamide in patients with chronic schizophrenia, currently being treated with a second-generation antipsychotic.

    Results from the study are expected by Q4 2022. Newron believes that positive results from this study would qualify the trial as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.

    Xadago®/safinamide

    For the continued clinical development of its marketed product Xadago®/safinamide, Newron has signed an agreement with its partner Zambon to commence a potentially pivotal study with safinamide in PD LID. This double-blind, placebo-controlled study is intended to be performed in the US, Europe and Asia/Australia, with a potential label extension for safinamide in key markets. Newron currently expects to initiate the study in Q1 2022.

    In May, Newron received some Paragraph IV Notice Letters regarding the submission by generic manufacturers of an Abbreviated New Drug Application to the US FDA, seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before the expiration of certain US patents. Newron and its partners Zambon and Supernus have responded in filing an infringement suit against the generic manufacturers to secure a 30-month stay of the ANDAs approval, and thus to protect its intellectual property rights relating to Xadago®/safinamide tablets. The compound is currently protected by three patents listed in the FDA’s Approved Drugs Product List (Orange Book) that expire no earlier than 2027.

    Financial Key Takeaways:

    -For the first six months of 2021, Newron reported a net loss of EUR 9.1 million, compared to EUR 10.5 million in the same period in 2020
    -Cash used in operating activities has increased to EUR 8.8 million from EUR 7.0 million in H1 2020
    -Xadago® revenues received from Zambon slightly increased from EUR 2.5 million in H1 2020 to EUR 2.7 million in the reporting period
    -Newron’s R&D expenses have fallen to EUR 6.8 million from EUR 7.8 million in H1 2020
    -G&A expenses were EUR 3.7 million in the first six months of 2021 versus EUR 4.4 million in the same period in 2020
    -Cash and Other current financial assets at June 30, 2021 were at EUR 21.9 million, compared to EUR 31.3 million at the beginning of the year
    -Post-period, on September 6, Newron received the fourth tranche of funds under its financing agreement with the EIB that was announced in 2018 and comprised of funding up to EUR 40 million. Tranche 4 consisted of EUR 7.5 million and will primarily be used to support the Company’s development programs in CNS diseases
    Financial Summary (IFRS):

    In thousand EUR (except per share information)


    H1 2021

    H1 2020

    Licence income/Royalties

    2,671

    2,509

    Research and development expenses

    (6,783)

    (7,777)

    General and administrative expenses

    (3,747)

    (4,374)

    Net profit/loss

    (9,063)

    (10,503)

    Profit/loss per share

    (0.51)

    (0.59)

    Cash used in operating activities

    (8,750)

    (7,039)


    As of June 30, 2021

    As of Dec. 31, 2020

    Cash and Other current financial assets

    21,906

    31,250

    Total assets

  9. #959
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    7,541
    Mentioned
    10 Post(s)
    Quoted
    1296 Post(s)
    Potenza rep
    42949686
    Dunque Newron capitalizza 37.000.000 Frs; fattura 5.900.000 Frs; alla luce di questi dati, forse, sarebbe più conveniente per gli azionisti fermare tutte le attività, azzerando i costi e distribuire agli azionisti un dividendo derivante dalle royalties dello Xadago.

  10. #960
    L'avatar di Implacabile
    Data Registrazione
    Oct 2007
    Messaggi
    7,541
    Mentioned
    10 Post(s)
    Quoted
    1296 Post(s)
    Potenza rep
    42949686
    Ora ondeggiamo attorno ai 2 franchi; la domanda è sempre valida: non è forse meglio fermare la dispendiosa fase clinica dell'evenamide e distribuire i dividendi derivanti dallo Xadago ?

Accedi