Under 2020 lade Saniona en solid grund för att omvandla verksamheten, från upptäcktsfas med fokus på att utlicensiera sina molekyler, till ett helintegrerat 

Saniona har fått klartecken av amerikanska läkemedelsmyndigheten FDA att utföra en säkerhetsstudie inom hjärta-kärl som en del av bolagets kliniska utvecklingsprogram för Tesomet inom hypotalamisk fetma. Studien sträcker sig över en kortare period, ett par månader, och inkluderar cirka 300 patienter.

Rami Levin, vd Saniona Tesomet provides its effect via an established mechanism of action that is relevant to both syndromic and nonsyndromic forms of obesity, providing an avenue to potentially developing the compound across multiple obesity disorders Rami Levin, vd Saniona This is a fantastic milestone for Saniona. Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling fokuserad på sällsynta sjukdomar, meddelar idag att data från bolagets kliniska Fas 2-studie med Tesomet på hypotalamisk fetma (HO) kommer att presenteras vid Endocrine Societys årsmöte 2021 (ENDO 2021), vilket avhålls virtuellt 20-23 mars 2021. Saniona AB (0RQJ) · Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity. 03 Mar 2021  04/21/21; Press Release.

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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. 2020-10-13 · Saniona completed a Phase 2a trial (NCT03149445) investigating the safety and efficacy of Tesomet in young adults with PWS. The study found that patients receiving once-daily Tesomet showed a decrease in weight, body mass index (BMI), and hyperphagia, or excessive eating, compared with patients on a placebo. 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.

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.

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 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 UPDATES TESOMET CLINICAL DEVELOPMENT TIMELINES BASED ON MANUFACTURING FEEDBACK FROM U.S. FDA * FDA AGREED WITH COMPANY'S PROPOSAL BUT REQUESTED ADDITIONAL INFORMATION REGARDING TESOMET Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control.

2021-04-19 · Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. The programs are currently in

Prövningsläkemedlet Tesomet är en fastdoskombination av tesofensin (en trefaldig monoaminåterupptagshämmare) och metoprolol (en beta-1-selektiv blockerare). Saniona avancerar Tesomet för behandling av hypotalamisk fetma och Prader-Willis syndrom, två allvarliga och sällsynta störningar som kännetecknas av fetma och störd aptitreglering. 2020-10-13 Sainona’s CEO: Saniona gains momentum advancing Tesomet for two rare diseases 17 september, 2020 On September 21, 2020, the exercise period ends for Saniona’s warrants of series TO 2, which can strengthen the company by approximately SEK 37 million before issue costs. Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity. See press release here.

2019-05-30 Saniona bjuder in investerare till en presentation av de positiva topline-resultaten från fas 2-studien: Tesomet för behandling av hypotalamisk fetma Publicerad: 2020-04-27 (GlobeNewswire) Saniona is Inviting Investors to Participate to a Presentation of the Positive Topline Results from the Phase 2 Trial: Tesomet for the Treatment of Hypothalamic Obesity 2019-03-11 2021-03-08 Saniona yesterday announced that the FDA has granted Orphan Drug Designation (ODD) for the drug candidate Tesomet in the treatment of Prader-Willi syndrome (PWS). BioStock reached out to Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona, to get his view on this important milestone and in what ways the ODD will help Saniona going forward. Saniona, currently redeeming the first out of three outstanding warrants, is approaching late-stage clinical studies with lead candidate Tesomet in two eating disorder indications.
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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. 2021-04-19 · Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control.

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. Fram till den 21 september 2020 kan innehavare av teckningsoptioner av serie TO 2 teckna en ny aktie i Saniona till en kurs om 25 kronor per aktie. Vid fullt nyttjande tillförs Saniona cirka 37 miljoner kronor före emissionskostnader, något som ytterligare stabiliserar finansieringen för utveckling av Tesomet. Rami Levin, vd Saniona Tesomet provides its effect via an established mechanism of action that is relevant to both syndromic and nonsyndromic forms of obesity, providing an avenue to potentially developing the compound across multiple obesity disorders Rami Levin, vd Saniona This is a fantastic milestone for Saniona.
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Saniona avancerar sin primära läkemedelskandidat Tesomet – en fastdoskombination av den trefaldiga monoaminåterupptagshämmaren tesofensine och betablockeraren metoprolol till nästa steg i den kliniska utvecklingen inom både hypotalamisk fetma (HO) och Prader-Willis syndrom (PWS), två sällsynta sjukdomar som för närvarande saknar godkända behandlingsalternativ.

Tesomet tolererades väl. Saniona har tidigare utvärderat Tesomet i en randomiserad, dubbelblind, placebokontrollerad Fas 2a-studie på vuxna och ungdomar med PWS. Vuxna patienter som gavs Tesomet uppnådde vid en dos av 0,5 mg per dag en statistiskt signifikant begränsning av hyperfagi liksom en kliniskt meningsfull viktnedgång. Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling fokuserad på sällsynta sjukdomar, meddelar idag att data från bolagets kliniska Fas 2-studie med Tesomet på hypotalamisk fetma (HO) kommer att presenteras vid Endocrine Societys årsmöte 2021 (ENDO 2021), vilket avhålls virtuellt 20-23 mars 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. 2020-10-13 · Saniona completed a Phase 2a trial (NCT03149445) investigating the safety and efficacy of Tesomet in young adults with PWS. The study found that patients receiving once-daily Tesomet showed a decrease in weight, body mass index (BMI), and hyperphagia, or excessive eating, compared with patients on a placebo.

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

The programs are currently in 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 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). Saniona is advancing Tesomet for 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 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.

Prissättningen av Tesomet Saniona uppger i sitt prospekt att kostnaderna för betalande parter i Saniona får godkännande för att starta fas 2a-studie på Tesomet för typ 2-diabetes tis, mar 15, 2016 08:55 CET. Saniona, ett ledande bioteknikföretag inom jonkanaler, meddelar idag att den tyska tillsynsmyndigheten Bundesamt für Arzneimittel und Medizinprodukte, BfArM, har godkänt Sanionas ansökan om en klinisk fas 2a-studie för Tesomet i typ 2-diabetespatienter.