Tag: Big Pharma
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How Jideytro Blocks ROS1 Fusion Signaling in Lung Cancer
Jideytro is a brain-penetrant, TRK-sparing macrocyclic inhibitor designed to block ROS1 fusion signaling and resistant variants such as G2032R.
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AbbVie’s Qulipta Meets Phase 3 Goal in Menstrual Migraine
AbbVie’s Qulipta met the Phase 3 LUNA primary endpoint in menstrual migraine, reducing perimenstrual migraine days with a seven-day regimen timed to the onset of menses.
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How Qulipta Blocks CGRP Signaling During the Menstrual Migraine Window
Estrogen withdrawal can increase migraine susceptibility around menstruation. Qulipta does not alter hormone levels; it blocks downstream CGRP receptor signaling during this predictable risk window.
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FDA Pauses Opakalim Enrollment Days After SK Biopharmaceuticals Deal
The FDA paused new enrollment in Biohaven’s opakalim program, adding regulatory uncertainty to SK Biopharmaceuticals’ $795 million epilepsy licensing deal.
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Bayer’s Hyrnuo Wins First-Line FDA Approval in HER2-Mutant Lung Cancer
The FDA granted Bayer’s Hyrnuo accelerated approval as a first-line treatment for HER2-mutant non-small cell lung cancer after the oral therapy achieved a 75% response rate in SOHO-01.
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How Hyrnuo Blocks Mutant HER2 Signaling in Lung Cancer
Activating HER2 mutations can sustain RAS–ERK and PI3K–AKT signaling in lung cancer. This explainer examines how Hyrnuo reversibly inhibits mutant HER2 kinase activity while limiting wild-type EGFR inhibition.
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Novartis’ Del-desiran Fails Phase 3, Deepening a Week of Pipeline Setbacks
Novartis’ del-desiran missed the primary endpoint in the Phase 3 HARBOR trial for DM1, raising questions about the $12 billion Avidity acquisition and the clinical translation of its AOC platform.
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How Toxic RNA Drives DM1—and Why Del-desiran Was Designed to Silence It
DM1 is driven by toxic CUG-repeat DMPK RNA that sequesters MBNL proteins and disrupts alternative splicing. This explainer examines how del-desiran was designed to correct that mechanism—and why molecular improvement did not translate into a positive Phase 3 primary endpoint.
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Novo Nordisk Halts Two More Phase 3 Ziltivekimab Trials After ZEUS Setback
Novo Nordisk has discontinued the Phase 3 HERMES and ATHENA trials of ziltivekimab after the earlier ZEUS failure raised doubts that IL-6 suppression would translate into cardiovascular benefit. ARTEMIS remains the key ongoing Phase 3 test of the program.
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Why Lowering IL-6 Wasn’t Enough: What Ziltivekimab’s Cardiovascular Setback Means
Ziltivekimab neutralizes the IL-6 ligand and suppresses downstream inflammatory signaling, but the Phase 3 ZEUS trial showed that strong reductions in free IL-6 and hsCRP did not translate into fewer major cardiovascular events.