Biotek-snakken — August 2024
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Infant Bacterial Therapeutics AB (publ), Interim report January 1 – June 30, 2024 https://storage.mfn.se/e4463f81-0644-4c84-87fa-25f773e47ef8/ibt-q2-2024-eng.pdf
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This spring, the regulatory work began to prepare IBT's drug application for IBP-9414. The work has intensified, and more sections are ready. As soon as we have received results from “The Connection Study” IBT intends to contact the FDA and discuss how they want us to submit our data with the objective of reaching the market as soon as possible
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Höjdpunkter från presentationen
Bolagets VD Magnus Corfitzen deltog igår på Carnegies Småbolagsdag 2024. Presentationen innehöll inga större överraskningar och sammanfattade utvecklingsläget i bolagets huvudprojekt Orviglance och Oncoral. Vi förväntar oss den fullständiga datautläsningen av SPARKLE-studien under Q4(24).
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Nästa steg för Orviglance blir nu att arbeta med att ta fram en marknadsansökan till regulatoriska myndigheter, vilket bolaget bedömer kommer kunna skickas in under mitten av 2025. Detta skulle implicera ett potentiellt marknadsgodkännande för Orviglance under 2026
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Xbrane Biopharma Q2 2024: A fight against the clock
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IBT’s phase III study shows no significant effects on the primary endpoints but a significant reduction in the secondary endpoint, all-cause mortality (August 30, 2024)
(nu med link)
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Infant Bacterial Therapeutics fase III-studie
Link til uddybende debat:
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IO Biotech's Phase 3 Trial Data Fails To Show Superiority In ORR For IO102-IO103 With KEYTRUDA https://proinvestor.com/investornyt/1207657/io-biotechs-phase-3-trial-data-fails-to-show-superiority-in-orr-for-io102-io103-with-keytruda
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