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Novo Ends Two Ziltivekimab Heart-Failure Trials & SynAct Plans Another Arthritis Trial
Season 1 Episode 167
Novo is ending the HERMES and ATHENA ziltivekimab trials after a monitoring committee judged them unlikely to succeed, leaving ARTEMIS as its remaini…
1 week, 3 days ago
Week in Review | Bristol's CAR-T Pause Was Three Months Old Before the Public Heard
Bristol Myers Squibb told regulators in early June. The rest of us found out this week, after an analyst note. Three months sat between those two fac…
1 week, 5 days ago
Novartis's Pelacarsen Misses—What's Next for Rivals? & FDA Approves Etcamah Before Progression
Season 1 Episode 165
Novartis's pelacarsen missed its cardiovascular endpoint despite lowering Lp(a)—what should Amgen and Lilly rethink? FDA accelerated approval brings …
2 weeks ago
AbbVie's Etentamig Clears Phase 3 Myeloma Trial on Both Endpoints & GSK Pays HUTCHMED $110M Upfront for KRAS-EGFR Drug
AbbVie's BCMA x CD3 bispecific etentamig met both primary endpoints in the Phase 3 CERVINO myeloma study — a 74.0% response rate versus 45.7% for sta…
2 weeks, 1 day ago
uniQure Files Huntington's Gene Therapy — FDA Reversed Twice Already
uniQure filed AMT-130 for FDA and UK approval on three-year Phase 1/2 data with a propensity-matched external control, and a potential accelerated-ap…
2 weeks, 2 days ago
Alumis TYK2 Pill Fails Lupus: What's Left of the Platform & Kazia's PI3K Inhibitor Cuts CRC Tumor Burden 52%
Alumis shares fell 55% after envudeucitinib missed every endpoint in a mid-stage systemic lupus study - and the CEO still sees a path to Phase 3 buil…
2 weeks, 3 days ago
Novartis, BMS Halt Autoimmune CAR-T Trials on Safety & FDA Clears Takeda's Mimrylo in Polycythemia Vera
Two of the biggest names in cell therapy just hit the brakes on the most ambitious idea in immunology - Novartis and Bristol Myers Squibb have paused…
2 weeks, 4 days ago
Week in Review | AstraZeneca's Wainua Missed in ATTR-CM: The Stabilizer Problem
Three hundred eighty-one events versus three hundred ninety-two — AstraZeneca and Ionis's Wainua (eplontersen) missed in ATTR-CM, and the Munich post…
2 weeks, 5 days ago
Cytokinetics Wins Non-Obstructive HCM, Stock Falls Anyway & Teva bids $57.5M for BioXcel asset as shares collapse 66%
Cytokinetics' aficamten hit both primary endpoints in non-obstructive hypertrophic cardiomyopathy — a 3.0-point symptom score gain — and the stock st…
3 weeks ago
Roivant's JAK1/TYK2 Pill Wins First Dermatomyositis Nod & Spyre Deprioritizes TL1A Drug After RA Miss
Roivant and Priovant won FDA approval for LISRAYA (brepocitinib) in dermatomyositis — 55% of patients achieved both symptom improvement and minimal s…
3 weeks, 1 day ago