Biotek-snakken — November 2025
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Lidt bagud med at høre diverse CCs - hørte Zymes i morges og min første tanke var, at bare nu ikke udskydelsen af data er fordi de tager alle patienter med. Man blev jo ikke klogere af deres CC, så vil se om jeg får tid til at høre Jazz´s CC i aften eller i morgen.
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Bliver så træt af disse ting der indimellem opstår og man aldrig kan få en reel forklaring, når det altid medfører usikkerhed efterfølgende. Dejligt at Zymes trods alt stiger i dag, for synes deres CC ellers var ganske godt. Hvor jeg tidligere ikke havde ret meget mod på deres pipeline, så har seneste data fra deres FRalfa studie vendt lidt op og ned på det…….og Janssen der er videre i fase III med KLK2/CD3.
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Moving to Slide 14. Our next major catalyst is the top line readout of the Phase III zanidatamab HERIZON-GEA-01 trial. As we announced today and after alignment with FDA, we have updated the intent-to-treat patient population for PFS to now include the fully enrolled patient population, increasing the PFS cohort from the targeted 714 to 920 patients, which is the actual number of enrolled patients as detailed on clinicaltrials.gov. As a reminder, we previously took the opportunity to expand the
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the patient population for the overall survival analysis by expanding the sample size for that endpoint. With progression events accruing more slowly than anticipated, combined with the study being fully enrolled with sufficient follow-up on enrolled patients, we aligned with the FDA to conduct the PFS analysis on the entire randomized patient population. Following this change, we continue to have robust powering to show a benefit for PFS, and we remain highly confident that we will announce
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Bioporto gennemfører fuldtegnet emission på 43 mio kr. https://proinvestor.com/investornyt/1383022/bioporto-gennemforer-fuldtegnet-emission-pa-43-mio-kr
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