Betydande viktminskning, lägre BMI och minskad hungerkänsla i patienter med PWS, det är resultatet av Sanionas fas II-förlängningsstudie

Shares of Denmark-based Saniona are up more than 14 percent on the Stockholm Exchange after the company announced it has been cleared to initiate the second part of a mid-stage trial to develop a treatment for adolescents with Prader-Willi Syndrome.

BioStock kontaktade Rudolf Baumgartner, MD, Chief Medical Officer och Head of Clinical Development på Saniona, för att få hans syn på denna viktiga milstolpe och på vilka sätt denna nya klassning kommer att hjälpa Saniona framåt. Saniona AB (publ), Smedeland 26B, DK-2600 Glostrup, Danmark Web: saniona.com E-post: saniona@saniona.com PRESSMEDDELANDE 9 oktober 2020 Saniona mottar pre-IND-besked från FDA om den regulatoriska hanteringen av Tesomet för Prader-Willis syndrom (PWS) och hypotalamisk fetma (HO) Saniona har nyligen rapporterat om slutförandet av fas IIa-studien med Tesomet i den svåra ätstörningssjukdomen Prader Willi (PWS). Studien var liten men resultaten tyder på att behandling med Tesomet i dos 0,25 mg per dag är väl tolererad och inga behandlingsrelaterade avhopp rapporterades. phase IIb clinical trial in PWS. Saniona intends to pursue a meeting with the FDA to help define a regulatory path forward for Tesomet in hypothalamic obesity .

Saniona pws

Regulatory approval decision in Mexico. H2 2020. Tesomet. Ph 2b study initated. Prader-Willi syndrome. We expect Saniona to initiate a ph 2b/3 study in PWS. Q4 2020. Tesomet.

Saniona genomför just nu en sista förlängning av en fas IIa-studie med justerad dosering mot patienter med Prader-Willis Syndrom (PWS), den vanligaste genetiska orsaken till livshotande övervikt. Studien väntas avslutas i juli månad. För att ytterligare stärka utvecklingen av läkemedelskandidaten Tesomet inom PWS och för att kunna förvalta lovande data på bästa sätt har Saniona […]

Saniona expects to begin this Phase 2b study in the first half of 2021. Saniona (OMX: SANION), a biotech company focused on CNS and eating disorders, today announced that it has completed the 3-month treatment period in adolescent patients in the second part of its Phase 2a study of Tesomet to treat Prader Willi syndrome (PWS). Saniona holds worldwide rights to Tesomet and is actively evaluating opportunities to advance this treatment globally. About Prader-Willi Syndrome (PWS) Prader-Willi syndrome (PWS) is a rare disease characterized by constant, extreme, ravenous, insatiable appetite (hyperphagia) which persists no matter how much the patients eat.

This financing was necessary for Saniona to be able to conduct Phase 2b clinical studies of lead program Tesomet in PWS and HO as well as to advance candidates SAN711 into Phase 1. In this financing, Saniona focused on attracting long-term investors who are aligned with our mission of bringing innovative treatments to patients.

sällsynta ätstörningarna hypotalamisk fetma (HO) och Prader-Willis syndrom (PWS). Vd:n Rami Levin klev in i Saniona i början av 2020 och Having reported positive results in both the targeted rare eating disorders, PWS and HO,. Saniona is now planning to take tesomet into a pivotal Saniona publicerar sin delårsrapport för det andra kvartalet 2020 spår som föreslagits för Tesomet mot Prader-Willis syndrom (PWS). Ytterligare studieframgång i PWS för Saniona https://www.biostock.se/2019/01/ytterligare-studieframgang-i-pws-for-saniona/ …pic.twitter.com/ Dagens besked om interimsanalys i PWS-studien får aktien på fall. Det är framför allt uppgifter om potentiella biverkningar som ligger bakom Läs aktieanalyser om Saniona från olika analyshus och analytiker. Willis syndromet (PWS) kan användas av ledningen i diskussionerna med 10:40 Förra veckan beviljades Saniona särläkemedelsklassning från FDA i den sällsynta sjukdomen Prader-Willis syndrom (PWS) med läkemedelskandidaten Jag upprepar att Saniona är en av de mest undervärderade aktierna på Ett börsvärde på 600 mkr när bara PWS indikationen skulle / borde Och till er som spyr galla över både Rami och Saniona uppmanar jag att och start av fas 2 b i både PWS & Ho så även start av fas 1 San 711. Saniona har nyligen rapporterat om slutförandet av fas IIa-studien med.

The treatment was well tolerated in this younger group of patients, and eight of the nine patients are currently Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tesomet for the treatment of Prader-Willi syndrome (PWS). Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) Saniona (SANION.ST), a clinical-stage biotech company focused on rare diseases, today announced it has completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Saniona has gotten the go-ahead it needs to continue a midstage trial of its combination therapy for Prader-Willi syndrome (PWS), a debilitating genetic disorder that causes insatiable appetite and Saniona is a rare disease biopharmaceutical company focused on research, development and commercialization of treatments for the central nervous system. The company has four programs in clinical Shares of Denmark-based Saniona are up more than 14 percent on the Stockholm Exchange after the company announced it has been cleared to initiate the second part of a mid-stage trial to develop a treatment for adolescents with Prader-Willi Syndrome. February 19, 2019 I Saniona (OMX: SANION), a biotech company focused on CNS and eating disorders, today reported an update on its ongoing dose-finding Phase 2a study of Tesomet in adolescent patients with Prader-Willi syndrome (PWS). The treatment was well tolerated in this younger group of patients, and eight of the nine patients are currently Saniona received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi syndrome (PWS) and HO. In Saniona received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi syndrome (PWS) and HO. In Forskningsbolaget Saniona får särläkemedelsklassning för sin läkemedelskandidat Tesomet mot Prader-Willis syndrom (PWS) av den amerikanska läkemedelsmyndigheten Saniona holds worldwide rights to Tesomet and is actively evaluating opportunities to advance this treatment globally. PRADER-WILLI SYNDROME .
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Saniona gör en företrädesemission för att slutföra pågående kliniska den pågående dosbestämningsstudien i Prader Willi (PWS) slutföras PWS - Saniona vs Soleno Therapeutics, BeyondObvious, 20-01-21 14: "Enrollment in DESTINY PWS remains on track for the availability of Saniona befinner sig i en intensiv fas just nu och tidigare i april kom även beskedet att PWS är en sjukdom som i dag saknar behandling.

8 Jan 2018 Saniona, a leading biotech company in the field of ion channels, today announced top line results from its exploratory Phase 2a clinical trial for 13 Nov 2020 UU. (FDA) ha brindado algunas recomendaciones a Saniona con respecto al desarrollo de Tesomet para tratar el síndrome de Prader-Willi (PWS) 12. okt 2020 Saniona står til at starte et fase 2b-studie med sit lægemiddel Tesomet mod spiseforstyrrelsen Prader Willi Syndrom (PWS) i første halvdel af 7 Jan 2020 Saniona, a clinical stage biotech company focused on rare diseases disorders Prader-Willi Syndrome (PWS) and in Hypothalamic Obesity 3 Jan 2017 Denmark-based biotech company Saniona has reported positive results Prader-Willi syndrome (PWS), binge eating, type 2 diabetes and fatty 6 days ago Saniona (OMX: SANION), a clinical stage biopharmaceutical in hypothalamic obesity (HO) and Prader-Willi syndrome (PWS), as well as to Saniona forbereder sig på at starte en fase 2b-undersøgelse med Tesomet ved PWS i første halvdel af dette år.
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2021-03-03

Saniona (OMX: SANION), a clinical-stage biotech company focused on rare diseases, today announced it has completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA), Office of Neuroscience and Division of Psychiatry, for the development of Tesomet in Prader-Willi syndrome (PWS), a rare disease with a large medical unmet need. Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling fokuserad på sällsynta sjukdomar, meddelar idag att man genomfört ett pre-IND-möte (Investigational New Drug) med det amerikanska läkemedelsverket FDA:s avdelning för neurovetenskap och psykiatri om utvecklingen av Tesomet för behandling av Prader-Willis syndrom (PWS), en sällsynt sjukdom med ett stort och Regarding PWS, the FDA’s Division of Psychiatry within the Office of Neuroscience provided additional feedback on conducting a supportive Phase 2b study evaluating multiple doses of Tesomet in adult and adolescent PWS patients. Saniona expects to begin this Phase 2b study in the first half of 2021. Saniona (OMX: SANION), a biotech company focused on CNS and eating disorders, today announced that it has completed the 3-month treatment period in adolescent patients in the second part of its Phase 2a study of Tesomet to treat Prader Willi syndrome (PWS).

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Willis syndromet (PWS) kan användas av ledningen i diskussionerna Vi sätter riktkursen för Saniona-aktien på 64 kronor (63) och förväntar

In particular, the agency is advising the company to conduct a Phase 3 trial to follow the planned Phase 2b clinical trial, as well as including children younger than 12. Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) Saniona announced that adolescents with Prader-Willi syndrome (PWS) showed improvements in weight, body mass index (BMI), and hyperphagia score — measuring appetite reduction — when treated with the investigational therapy Tesomet in a 24-week, open-label extension of a Phase 2a clinical trial. Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tesomet for the treatment of Prader-Willi syndrome (PWS). Saniona is exploring the therapeutic impact of Tesomet in PWS patients in a randomized, double-blind, placebo-controlled Phase 2a trial.