Biotek-snakken — August 2024
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Weekly Biotech Buzz: AADI Trims R&D Jobs, JNJ Loosens Purse Strings, FDA Snubs REGN's Myeloma Drug https://proinvestor.com/investornyt/1204790/weekly-biotech-buzz-aadi-trims-rampd-jobs-jnj-loosens-purse-strings-fda-snubs-regns-myeloma-drug
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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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