Tag: Phase 3
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Vaxcyte’s VAX-31 Meets Phase 3 Endpoints Versus Prevnar 20 and Capvaxive
Vaxcyte’s VAX-31 met all prespecified primary endpoints in the Phase 3 OPUS-1 trial, supporting its potential as a broader adult pneumococcal vaccine. The candidate includes all 20 Prevnar 20 serotypes plus 11 additional serotypes.
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Eli Lilly’s Jaypirca Wins FDA Approval for First-Line CLL/SLL
The noncovalent BTK inhibitor reduced the risk of progression or death by 80% versus bendamustine plus rituximab in previously untreated patients without known del(17p). Key Takeaways Data Snapshot Item Details Company Eli Lilly Drug Jaypirca (pirtobrutinib) FDA approval date October 2, 2026 Indication Previously untreated adult CLL/SLL without known del(17p) Pivotal trial Phase 3 BRUIN…
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Kodiak Phase 3: Zenkuda Shows 24-Week Durability in Wet AMD
Kodiak’s Phase 3 DAYBREAK trial met its primary endpoint for both Zenkuda and KSI-501 in wet AMD. Zenkuda stood out as 54% of patients reached 24-week dosing, while KSI-501 met noninferiority without yet establishing a clear added benefit from IL-6 inhibition.
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J&J’s CAPLYTA Meets Phase 3 Trial Goal in Bipolar Mania
Johnson & Johnson’s CAPLYTA met the primary endpoint in Phase 3 Study 451, producing a 4.8-point greater reduction in manic symptoms versus placebo and significant improvement from Day 3. Results from the second pivotal study remain under analysis.
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Eli Lilly’s Inluriyo–Verzenio Combination Wins FDA Approval in ESR1-Mutated Breast Cancer
The FDA approved Eli Lilly’s Inluriyo plus Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy. In an exploratory EMBER-3 analysis, median progression-free survival was 11.1 months with the combination versus 5.5 months with Inluriyo alone.
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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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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.