Newron

  • Ecco la 60° Edizione del settimanale "Le opportunità di Borsa" dedicato ai consulenti finanziari ed esperti di borsa.

    Questa settimana abbiamo assistito a nuovi record assoluti in Europa e a Wall Street. Il tutto, dopo una ottava che ha visto il susseguirsi di riunioni di banche centrali. Lunedì la Bank of Japan (BoJ) ha alzato i tassi per la prima volta dal 2007, mettendo fine all’era del costo del denaro negativo e al controllo della curva dei rendimenti. Mercoledì la Federal Reserve (Fed) ha confermato i tassi nel range 5,25%-5,50%, mentre i “dots”, le proiezioni dei funzionari sul costo del denaro, indicano sempre tre tagli nel corso del 2024. Il Fomc ha anche discusso in merito ad un possibile rallentamento del ritmo di riduzione del portafoglio titoli. Ieri la Bank of England (BoE) ha lasciato i tassi di interesse invariati al 5,25%. Per continuare a leggere visita il link

syncro

Nuovo Utente
Registrato
23/8/07
Messaggi
1.188
Punti reazioni
75
Newron initiates U.S. Phase II trial in patients with schizophrenia
NW-3509 - First voltage-gated sodium channel blocker as add-on therapy for the treatment of schizophrenia
Milan, Italy, December 2, 2015 – Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, announced today the initiation of a U.S. Phase II study with its novel sodium channel blocker, NW-3509, in patients with schizophrenia. NW-3509 is an orally available new chemical entity that specifically targets voltage-gated sodium channels, acting with a unique mechanism of action.
The Phase II trial is designed to investigate safety and preliminary evidence of efficacy in a double-blind, placebo-controlled randomized trial. NW-3509 will be administered as add-on treatment in schizophrenic patients experiencing break-through psychotic symptoms while on stable and adequate doses of their current atypical antipsychotics. The 4-week study will be performed in a minimum of 60 patients in two U.S. study centers. Patients will be treated twice daily with 5-25 mg/day of NW-3509, or placebo. The doses to be tested in this study in patients were found to be well-tolerated in healthy subjects and were associated with plasma levels that overlapped with exposure shown to be effective in preclinical models of psychosis. Doses and study design were finalized after receiving FDA input and guidance. Study results are expected to be available in Q4 2016.
The potential benefits of NW-3509 have been demonstrated in numerous animal models predictive of efficacy in psychiatric diseases, including models of psychosis such as amphetamine-induced hyperactivity, sensorimotor gating and information processing deficits (pre-pulse inhibition impairment induced by different stimuli), mania and depression.
Ravi Anand, M.D., Ph.D., Newron’s Chief Medical Officer, stated: “The addition of NW-3509 in patients not responding to their current antipsychotic treatment may improve positive symptoms. New preclinical results also indicate that NW-3509 improves social withdrawal due to Phencyclidine or PCP (“angel dust”), an important predictor of negative symptom improvement.”
About schizophrenia
Schizophrenia is a long-term mental health condition that causes a range of different psychological symptoms. It is one of the most common serious mental health conditions. About 1 in 100 people will experience schizophrenia in their lifetime, with many continuing to lead normal lives. Schizophrenia is most often diagnosed between the ages of 15 and 35. Men and women are affected equally. There is no single test for schizophrenia. It is most often diagnosed after an assessment by a mental health care professional, such as a psychiatrist. It is important that schizophrenia is diagnosed as early as possible, as the chances of recovery improve the earlier it is treated. Schizophrenia is often described in terms of positive and negative (or deficit) symptoms. Positive symptoms are those that most individuals do not normally experience but are present in people with schizophrenia. They can include delusions, disordered thoughts and speech, and tactile, auditory, visual, olfactory and gustatory hallucinations, typically regarded as manifestations of psychosis. Hallucinations are also typically related to the content of the delusional theme. Positive symptoms generally respond well to medication. Negative symptoms are deficits of normal emotional responses or of other thought processes, and are less responsive to medication. They commonly include flat expressions or little emotion, poverty of speech, inability to experience pleasure, lack of desire to form relationships, and lack of motivation. Negative symptoms appear to contribute more to poor quality of life, functional ability, and the burden on others than do positive symptoms. People with greater negative symptoms often have a history of poor adjustment before the onset of illness, and response to medication is often limited.
About NW-3509
NW-3509 is an orally available new chemical entity that specifically targets voltage-gated sodium channels. The compound modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. NW-3509 normalizes glutamate release induced by aberrant sodium channel activity. The potential benefits of NW-3509 have been demonstrated in numerous preclinical models predictive of efficacy in psychiatric diseases, including models of psychosis such as amphetamine-induced hyperactivity, sensorimotor gating and information processing deficits (pre-pulse inhibition impairment induced by different stimuli), mania and depression. Efficacy of NW-3509 has also been demonstrated in models of aggression and compulsive behavior, as well as in short- and long-term memory tests. Sub-threshold doses of NW-3509 increased the activity of inactive doses of both typical and atypical antipsychotics in models of schizophrenia, psychosis and mania. Moreover, given its neuronal stabilization properties, NW-3509 may reduce relapses and prevent or treat episodes of psychosis due to established super-sensitivity psychosis (SSP) induced by antipsychotics. As it is devoid of the risk of drug-induced movement disorders or weight gain, NW-3509 can be given in combination for extended periods of time.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Marketing authorization in the EU for Xadago® (safinamide) for the treatment of Parkinson’s disease was granted by the EU Commission in February 2015, followed by the launch by Zambon in the first key EU country - Germany - in May 2015. The New Drug Application (NDA) has been accepted for review by the FDA, as reported in March 2015. In November 2015, Swissmedic has granted marketing authorization to Zambon, Newron’s partner. Zambon has the rights to develop and commercialize safinamide globally, excluding Japan and other key Asian territories, where Meiji Seika has the rights to develop and commercialize the compound. Newron’s additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development. They include sarizotan for patients with Rett syndrome, for which Newron received Orphan Drug Designation in both the US and the EU, ralfinamide for patients with specific rare pain indications, and NW-3509 as potentially the first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For additional information, please visit Home - Newron Pharmaceuticals
 
ciao, quando ho letto la notizia ho pensato finalmente......ma credevo in una reazione positiva del marcato...invece nulla.....
 
ciao, quando ho letto la notizia ho pensato finalmente......ma credevo in una reazione positiva del marcato...invece nulla.....


In effetti dopo tanta attesa si poteva attendere un bel rialzo. Ma ti dirò una cosa: il rialzo ci sarà solo se la fase clinica II andrà a buon fine e la Newron troverà una Big Pharma che sponsorizzerà la costosissima fase clinica III.

Per ora ci tocca aspettare il 29 marzo e sperare che la FDA ci dia la sua approvazione.
 
Chissà se ci sarà lo sprint di fine anno come previsto da Dollar ?
Abbiamo aperto l'anno a 26,30 e, dopo un anno, siamo ancora a quel livello. Io non pretendo molto, ma almeno 30.00 franchi mi farebbero felice.
 
Chissà se ci sarà lo sprint di fine anno come previsto da Dollar ?
Abbiamo aperto l'anno a 26,30 e, dopo un anno, siamo ancora a quel livello. Io non pretendo molto, ma almeno 30.00 franchi mi farebbero felice.


Caro implacabile, io mi tengo un puo fuori dall giro, per non darvi troppo fastidio... il mio target resta, o usato il ribasso per comprare qualche centinaia di pezzi, lo sai, io restero solo a lungotermine, non importa a me se pago 26 o 29.

un abbraccio e tenete duro pazzoidi
 
Caro Dollar, temo, anzi sono ormai certo, che il tuo target price per fine anno non verrà centrato.
Purtroppo le cose non sono andate come speravamo e il prezzo dell'azione ne ha risentito.
Mi domando comunque come mai nessuna Big Pharma si sia fatta avanti per Opare la nostra Newron; di solito succede che le piccole biotech che hanno successo nelle fasi cliniche, vengono assorbite da un big del settore. Forse stanno aspettando la risposta della FDA.
Per ora il 2015 è stato un anno buttato alle ortiche.
 
spremuto per bene , nessuno piu che vuole vendere pezzi grandi, esplossione arriva !
 
indanto settimana prossima o tra po, cominceremo a vendere in svizzera e grande parte europa lo xadago, e ZAMBON PAGA....
 
indanto settimana prossima o tra po, cominceremo a vendere in svizzera e grande parte europa lo xadago, e ZAMBON PAGA....

Credo che per il momento incasseremo pochi euro, visto che lo xadago è in vendita solo in Germania e lo scorso trimestre abbiamo incassato solo 83.000 €

Certo sarebbe ora che riuscissero a ottenere il prezzo di vendita in tutta Europa e cominciare così a fare dei fatturati seri.
 
Indietro