Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome. PRESS RELEASE. March 3, 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).

About TesometTesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing

03 mars 2021 kl 13:00. PRESSMEDDELANDE. 3 mars 2021. Saniona Safe Return Asset Management Nordic Saniona - en sannolik vinnare. Tesomet, som just nu är Sanionas mest avancerade program och på Forskningsbolaget Saniona kommer att presentera data från bolagets kliniska fas 2-studie med Tesomet på hypotalamisk fetma vid Endocrine Forskningsbolaget Saniona har för närvarande nyttjandeperiod för Tesomet är Sanionas mest avancerade produkt under utveckling, och Saniona utvärderar också Tesomet för behandling av Prader-Willis syndrom (PWS), och avser att inleda en fas 2b-studie inom denna indikation Tesomet tolererades väl av patienterna med hypotalamisk fetma under hela den 48 veckor långa studien (24 veckor dubbelblind del följt av 24 Saniona går in i andra delen av Fas 2a-studien med Tesomet för Prader-.

Tesofensine is considered a triple monoamine reuptake inhibitor, which means it prevents the reabsorption of three neurotransmitters — dopamine, serotonin, and noradrenaline — by nerve cells. Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome. See press release here. Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for Tesomet is a combination of two medications — tesofensine and metoprolol. The first, tesofensine, prevents the reuptake of serotonin, norepinephrine, and dopamine — three main signaling molecules that regulate brain activity.

26 Apr 2018 Saniona has gotten the go-ahead it needs to continue a midstage trial reuptake inhibitor tesofensine and beta blocker metoprolol (Tesomet)

2021-04-21 · Saniona anticipates that addressing these requests will delay the start of the Phase 2b trials of Tesomet for Prader-Willi syndrome (PWS) and hypothalamic obesity (HO) into the second half of 2021. Saniona’s Tesomet data will be featured in a live oral presentation titled, “Weight Loss, Improved Body Composition and Fat Distribution by Tesomet in Acquired Hypothalamic Obesity,” presented by Professor Ulla Feldt-Rasmussen, M.D., DMSc., Department of Medical Endocrinology and Metabolism, Rigshospitalet Copenhagen University Hospital, and Principal Investigator on the Phase 2 study.

Proceeds from the sales will continue to be used to advance Saniona’s clinical trials with Tesomet in hypothalamic obesity (HO) and Prader-Willi syndrome (PWS), as well as to advance its

Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic obesity and Prader Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. Prövningsläkemedlet Tesomet är en fastdoskombination av tesofensine (en trefaldig monoaminåterupptagshämmare) och metoprolol (en beta-1-selektiv blockerare).

The first, tesofensine, prevents the reuptake of serotonin, norepinephrine, and dopamine — three main signaling molecules that regulate brain activity. Increasing the amounts of these neurotransmitters outside brain cells can reduce appetite. Proceeds from the sales will continue to be used to advance Saniona’s clinical trials with Tesomet in hypothalamic obesity (HO) and Prader-Willi syndrome (PWS), as well as to advance its Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control.

Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker).
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About Saniona Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. The company’s lead product candidate, Tesomet, is in mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome, severe rare disorders characterized by uncontrollable hunger and intractable weight gain.

Tesofensine is considered a triple monoamine reuptake inhibitor, which means it prevents the reabsorption of three neurotransmitters — dopamine, serotonin, and noradrenaline — by nerve cells. PRESS RELEASE April 2 2 , 2021 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that it received feedback from the U.S. Food and Drug Administration (FDA) regarding its proposed chemistry, manufacturing and controls (CMC) plans for Tesomet. About TesometTesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control.

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March 4, 2021: BioStock article: Saniona´s CMO on the FDA’s Orphan Drug Designation for Tesomet in Prader-Willi Syndrome. Link. February 4, 2021: BioStock article: Saniona's Chief Communications Officer on the importance of communication. Link. January 12, 2021: BioStock article: Saniona's CEO on the plans for 2021. Link.

See press release here. 2019-09-24 · 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. Läkemedelsbolaget Saniona utvecklar Tesomet, ett läkemedel som i tidigare studier visat sig vara dramatiskt viktminskande. Vi kontaktade Sanionas vice vd Thomas Feldthus för att få veta mera om skillnaderna mellan Tesomet och nuvarande behandlingsalternativ. Fördubblade kostnader för typ 2-diabetes i Sverige på åtta år Saniona får återkoppling från FDA gällande den regulatoriska vägen framåt för Tesomet mot hypotalamisk fetma. Se pressmeddelande här Innehavare av TO2 äger rätt att för varje teckningsoption teckna en ny aktie i Saniona till en kurs om 25 SEK per aktie. För BioStock berättar Sanionas vd Rami Levin att befintlig kliniska data pekar på att man kommer att nå marknad med läkemedelskandidaten Tesomet inom två sällsynta ätstörningssjukdomar.