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126 stories matching this filter · ← front page

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  • Novartis reports Phase 3 pelacarsen trial fails to improve cardiovascular outcomes
    Novartis said its late-stage Phase 3 trial of the antisense drug pelacarsen did not show a benefit in reducing major cardiovascular events compared with placebo. The result adds to a recent string…
    Endpoints · 6h agoNegative readoutNegative↗ source
  • Novo Nordisk abandons two phase 3 trials of ziltivekimab, dimming blockbuster hopes
    Novo Nordisk announced it is terminating two late‑stage phase 3 studies of its IL‑6 ligand antibody ziltivekimab. The Hermes and Athena trials enrolled about 4,900 and 673 patients with heart fail…
    Fierce Biotech · 12h agoNegative readoutNegative↗ source
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Psychiatry & CNS858
Ophthalmology491
Pain469
Endocrinology & Metabolism466
Infectious Disease437
  • Novo Nordisk halts two late-stage ziltivekimab heart trials after futility finding
    Novo Nordisk announced it has stopped work early on two additional late-stage clinical studies of its IL-6 inhibitor ziltivekimab, which was being evaluated for heart disease. The decision followe…
    Endpoints · 13h agoNegative readoutNegative↗ source
  • Ionis secures FDA approval for zilganersen, a first treatment for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its antisense drug zilganersen for the treatment of Alexander disease, an ultra‑rare neurodegenerative disord…
    Fierce Biotech · 3d agoApprovalPositive↗ source
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3d agoLayoffsNegative↗ source
  • FDA approves Ionis’ Zanvastro as first disease-modifying therapy for Alexander disease
    The U.S. Food and Drug Administration has granted approval to Ionis Pharmaceuticals' antisense oligonucleotide Zanvastro, the first therapy that modifies disease progression for Alexander disease.…
    BioSpace · 3d agoApprovalPositive↗ source
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 5d agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 5d agoNegative readoutNegative↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 5d agoNeutral↗ source
  • Roche partners with China's Simcere Zaiming on $1.5 billion T-cell engager for B-cell diseases
    Roche announced a licensing agreement with Simcere Zaiming, a subsidiary of China's Simcere Pharmaceutical Group, to develop a trispecific T-cell engager called SIM0660. The deal includes an upfro…
    BioSpace · 6d agoDealPositive↗ source
  • Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries
    Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem. The problem involves re…
    Fierce Biotech · 6d agoCRLNegative↗ source
  • Absci CEO envisions AI-driven, consumer-focused drug platform, eyeing hair loss, endometriosis and future GLP-1 combos
    Absci, an AI‑focused biotech founded about 15 years ago in Vancouver, Washington, is led by CEO Sean McClain, who likens his ambition for the company to creating the Apple of biotech. The surge in…
    Fierce Biotech · 6d agoPositive↗ source
  • Analysts see opportunity for Alnylam’s RNAi therapy after AstraZeneca/Ionis ATTR-CM trial fails
    AstraZeneca and its partner Ionis reported a disappointing Phase 3 result for the antisense drug Wainua in transthyretin amyloid cardiomyopathy (ATTR-CM). The unexpected outcome was a focal point o…
    Fierce Biotech · 7d agoNegative readoutNeutral↗ source
  • Arrowhead’s plozasiran shows favorable safety in severe hypertriglyceridemia late-stage trials
    Arrowhead presented late-stage data for its RNA interference therapy plozasiran, marketed as Redemplo, in severe hypertriglyceridemia at the European Society of Cardiology 2026 meeting in Munich.…
    BioSpace · 7d agoPositive readoutNeutral↗ source
  • AstraZeneca's oral relaxin agonist shows positive phase 2b results in chronic heart failure
    AstraZeneca presented phase 2b data from its Luminara trial at the European Society of Cardiology Congress in Munich. The study evaluated the oral relaxin agonist AZD5462 in patients with chronic h…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • BMS leverages Celgene merger to revive neuroscience pipeline amid delayed readouts
    Bristol Myers Squibb, long recognized for its oncology work, is re‑investing in neurological and psychiatric disease programs, a move rooted in assets gained from its 2019 $74 billion Celgene merge…
    BioSpace · 7d agoNeutral↗ source
  • AstraZeneca’s oral relaxin drug shows partial success in mid-stage heart-failure trial
    AstraZeneca reported that its oral relaxin agonist improved cardiac function in a subset of patients enrolled in a mid-stage heart‑failure study. The trial demonstrated measurable benefits for some…
    Endpoints · 8d agoPositive readoutPositive↗ source
  • Arrowhead's RNAi drug Redemplo shows safety advantage over Ionis in late-stage triglyceride trials
    At the European Society of Cardiology meeting in Munich, Arrowhead Pharmaceuticals presented new data on its RNA interference candidate Redemplo. Redemplo was evaluated in two late-stage studies i…
    Endpoints · 8d agoPositive readoutPositive↗ source
  • Novartis launches Phase 3 trial of IL-6 antibody to test cardiovascular benefit despite Novo's setback
    Novartis announced it will begin a Phase 3 study evaluating its anti-IL-6 monoclonal antibody in patients at high cardiovascular risk. The trial aims to determine whether reducing inflammation thr…
    Endpoints · 9d agoNeutral↗ source
  • Eli Lilly’s Mounjaro receives FDA approval to lower cardiovascular risk; Teva announces acquisition of approved drug
    Eli Lilly’s once‑a‑diabetes blockbuster tirzepatide, marketed as Mounjaro, was granted FDA approval on Friday for an indication that reduces the risk of major cardiovascular events. The approval e…
    Endpoints · 10d agoApprovalPositive↗ source
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 10d agoApprovalPositive↗ source
  • Phase 3 trial shows Wainua fails to improve outcomes in ATTR-CM, hazard ratio 1.14
    AstraZeneca and Ionis Pharmaceuticals presented detailed results from the Phase 3 trial of their antisense oligonucleotide Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardi…
    BioSpace · 10d agoNegative readoutNegative↗ source
  • Priovant's Lisraya receives first FDA approval as oral therapy for dermatomyositis
    The U.S. Food and Drug Administration has cleared Priovant Therapeutics' daily TYK2/JAK1 inhibitor tablet, marketed under the name Lisraya, for the treatment of dermatomyositis in adults. Lisraya…
    BioSpace · 10d agoApprovalPositive↗ source
  • AstraZeneca and Ionis gene silencer Wainua fails trial after patients also took Pfizer heart drug
    At the ESC Congress in Munich, a high‑profile trial of the gene‑silencing therapy Wainua, developed by AstraZeneca and Ionis, was reported to have failed. The failure was linked to participants co…
    Endpoints · 10d agoNegative readoutNegative↗ source