Tag: pharmaceutical industry
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Skyhawk’s SKY-0515 Posts 1.59-Point cUHDRS Advantage at 15 Months
Skyhawk’s SKY-0515 showed a 1.59-point cUHDRS advantage over an external control at Month 15, alongside sustained reductions in mutant huntingtin and PMS1 messenger RNA.
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BioNTech’s Gotistobart Posts 18.5-Month Median Survival in Squamous NSCLC
Gotistobart achieved median overall survival of 18.5 months versus 10.0 months with docetaxel in the non-pivotal stage 1 portion of PRESERVE-003.
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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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Scholar Rock’s Isembyld Wins FDA Approval for Spinal Muscular Atrophy
The FDA approved Scholar Rock’s Isembyld for patients aged two years and older receiving SMN2-targeted therapy, adding the first muscle-directed treatment to established SMA care.
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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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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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FDA Approves Ionis’ Zanvastro as the First Treatment for Alexander Disease
The FDA approved Ionis’ Zanvastro as the first treatment for Alexander disease, validating GFAP-targeted antisense therapy in an ultra-rare neurological disorder.
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Novartis Remibrutinib Delivers Two Phase 3 Wins in Relapsing Multiple Sclerosis
Novartis reported positive Phase 3 results for remibrutinib in both REMODEL-1 and REMODEL-2, with significant reductions in annualized relapse rate versus teriflunomide and no liver safety signal reported across the two studies.
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Revolution Medicines Wins FDA Approval for Rasonque in Metastatic Pancreatic Cancer
The FDA approved Rasonque (daraxonrasib) for metastatic pancreatic adenocarcinoma after Phase 3 RASolute 302 showed a major survival benefit over chemotherapy.
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Jazz Wins First-Line FDA Approval for Ziihera in HER2-Positive Gastroesophageal Cancer
The FDA approved Ziihera for first-line HER2-positive gastroesophageal adenocarcinoma, strengthening Jazz Pharmaceuticals’ solid-tumor oncology strategy.