Biotek-snakken — November 2024
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Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that its partner, Productos Medix S.A de S.V (Medix), has not received approval from the Mexican regulatory agency (Cofepris) for tesofensine for the treatment of obesity. Instead, Medix is entering a dialogue with the agency regarding the path forward as it appears that the decision by Cofepris has not been based on the full data package as submitted by Medix.
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The application is based on a Phase 3 program involving 372 patients conducted by Medix. The study confirmed compelling efficacy, with patients achieving an average weight loss of about ten percent in 24 weeks, and more than half of the patients experiencing a weight loss of more than ten percent. In general, tesofensine was very well tolerated, and a clinical safety database containing approximately 1600 patients provided a robust safety dataset.
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Heldigvis er Teso ikke afvist, men de kræver blot flere data, så ja der er håb endnu og dagens kæmpe fald er klart en købsmulighed for den risikovillige.
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Ascelia Pharma Announces Completion of Full Study Report Reinforcing the Successful Outcomes of Orviglance Phase 3 Study SPARKLE
Ascelia Pharma Announces Completion of Full Study Report Reinforcing the Successful Outcomes of Orviglance Phase 3 Study SPARKLE – ASCELIA
Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announce ...
(www.ascelia.com)
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Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced the completion of the Full Study Report for the pivotal Phase 3 Study for Orviglance
liver imaging drug candidate, which includes the previously announced strong results of primary endpoints. In addition, the results of secondary endpoints further reinforce the successful study outcomes and support the New Drug Application (NDA) process. -
Curasight: Clinical phase II trial of uPAR-PET in brain cancer patients published; data supports development of uTREAT for brain cancer https://news.cision.com/curasight/r/clinical-phase-ii-trial-of-upar-pet-in-brain-cancer-patients-published--data-supports-development-of,c4062536
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Kvartalsrapport Q3: Framgångsrikt utfall av företrädesemission om 105 MSEK förlänger kassalikviditeten till sent 2025
https://www.ascelia.com/sv/ir-media-sv/finansiella-rapporter/
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FINANSIELL UTVECKLING I SAMMANDRAG FÖR Q3 (jul-sep) 2024
• Rörelseresultatet uppgick till -17,8 MSEK (-21,4 MSEK)
• Vinst per aktie uppgick till -0,42 SEK (-0,63 SEK)
• Kassaflöde från den löpande verksamheten uppgick till -17,0 MSEK (-31,0 MSEK)
• Likvida medel inkl. kortfristiga placeringar uppgick till 95,7 MSEK (39,0 MSEK) -
En presentation för analytiker, investerare och media hålls idag 7 november kl. 10:00. Rapporten presenteras av företagets CEO Magnus Corfitzen, Deputy CEO Julie Waras Brogren och CSO Andreas Norlin. Presentationen kommer att hållas på engelska. Presentationen kan följas live via följande länk:
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