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866 stories matching this filter · ← front page

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  • Inhibrx’s OX40 agonist plus Keytruda shows 48% response rate, beating Keytruda alone in head and neck cancer Phase 2
    Inhibrx reported results from its Phase 2 HexAgon trial evaluating INBRX-106, an OX40 receptor agonist, combined with Merck’s Keytruda in patients with treatment‑naïve, PD‑L1‑positive metastatic or…
    BioSpace · 4h agoPositive readoutPositive↗ source
  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 8h agoApprovalPositive
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  • Novartis' $12 billion Avidity drug fails Phase 3 trial in myotonic dystrophy
    Novartis reported that its antibody-oligonucleotide conjugate del-desiran did not meet the primary endpoint in the Phase 3 HARBOR study for myotonic dystrophy type 1, showing no significant improve…
    BioSpace · 6h agoNegative readoutNegative↗ source
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 8h agoPositive readoutPositive↗ source
  • Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries
    Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level. The recall, issued June 17, covers all unused l…
    Fierce Biotech · 10h agoCRLNegative↗ source
  • Structure Therapeutics reports oral GLP-1 weight-loss results comparable to Wegovy and strong Phase 1 amylin data
    Structure Therapeutics announced that its oral GLP-1 candidate aleniglipron achieved 72-week weight-loss results that BMO Capital Markets said were in line with Novo Nordisk’s oral Wegovy. Particip…
    BioSpace · 4h agoPositive readoutPositive↗ source
  • Novo Nordisk halts two more late-stage heart failure trials, calling IL-6 an invalid target
    Novo Nordisk said it is ending two late-stage heart-failure studies, HERMES and ATHENA, that were testing its IL-6 inhibitor ziltivekimab. The company cited a recommendation from the Data Monitorin…
    BioSpace · 4h agoNegative readoutNegative↗ source
  • FDA approves AstraZeneca's oral SERD Etcamah for HR+/HER2-negative advanced breast cancer
    FDA granted approval to AstraZeneca's camizestrant, marketed as Etcamah, an oral selective estrogen receptor degrader (SERD) for a specific subset of advanced breast cancer patients. The indicatio…
    BioSpace · 6h agoApprovalPositive↗ source
  • BrainChild Bio secures $119M Series A to advance CAR-T therapy for deadly pediatric brain tumor
    BrainChild Bio announced a $119 million Series A financing round aimed at moving its CAR‑T programs for central nervous system cancers in children forward. The company’s lead candidate, BCB-276, w…
    BioSpace · 7h agoDealPositive↗ source
  • Spyre Therapeutics reports positive Phase 2 results for anti-IL-23 antibody SPY003 in ulcerative colitis
    Spyre Therapeutics announced that its anti‑IL‑23 antibody, SPY003, achieved its primary and secondary goals in a Phase 2 ulcerative colitis study. The trial, part A of the Skyline program, enrolled…
    Fierce Biotech · 9h agoPositive readoutPositive↗ source
  • BMS CAR-T therapy arlo-cel meets primary endpoint in pivotal multiple myeloma trial
    Bristol Myers Squibb reported that its GPRC5D-directed CAR-T cell therapy, arlo-cel, achieved the primary endpoint in the pivotal Quintessential trial for multiple myeloma. The study enrolled pati…
    Fierce Biotech · 9h agoPositive readoutPositive↗ source
  • Moderna and Merck’s personalized mRNA cancer vaccine success spurs industry shift to faster, smaller-scale production
    After mastering large‑scale mRNA manufacturing during the COVID‑19 pandemic, the sector is now turning its attention to delivering individualized vaccines to patients quickly. The recent clinical…
    BioSpace · 14h agoPositive↗ source
  • Parkinson's drug pipeline diversifies as firms seek disease-modifying therapies
    Several pharmaceutical companies are shifting away from the traditional alpha-synuclein antibody strategy and exploring alternative mechanisms to treat Parkinson's disease. AC Immune is highlighted…
    BioSpace · 14h agoNeutral↗ source
  • Roivant's mosliciguat shows strong Phase 2 results, advancing to Phase 3 for PH-ILD
    Mosliciguat, the pulmonary hypertension candidate from Roivant Sciences subsidiary Pulmovant, cut pulmonary vascular resistance by more than 56% in a Phase 2 trial of patients with PH‑ILD, surpassi…
    BioSpace · 4h agoPositive readoutPositive↗ source
  • Moonwalk Biosciences raises $70M to move RNAi obesity drug MW101 toward first-in-human trials in 2027
    Moonwalk Biosciences, an obesity drug developer backed by Eli Lilly, announced a $70 million Series B financing. The funding will support its lead RNAi candidate, MW101, which in mouse studies pro…
    BioSpace · 6h agoDealPositive↗ source
  • Novartis' pelacarsen fails Phase 3, casting doubt on Lp(a) lowering strategy
    Novartis announced that its antisense drug pelacarsen failed to meet the primary endpoint in the Phase 3 Lp(a)HORIZON trial. The study was intended to determine whether the drug’s ability to lower…
    BioSpace · 6h agoNegative readoutNegative↗ source
  • Pharvaris reports 83% drop in hereditary angioedema attacks in phase 3 trial, FDA decision pending
    Pharvaris announced that its oral bradykinin B2 receptor antagonist, deucrictibant, met the primary goal in a second phase 3 study. The trial, called CHAPTER-3, enrolled 85 patients with three for…
    Fierce Biotech · 9h agoPositive readoutPositive↗ source
  • Benelux’s strong science base eyed for biotech scaling despite funding gaps
    Belgium and the Netherlands have built some of Europe’s strongest life‑science ecosystems, anchored by leading research institutions and a growing pool of biotech talent. Early‑stage capital remai…
    BioSpace · 11h agoPositive↗ source
  • AI can transform drug discovery only when its strengths are properly leveraged
    The article notes a split narrative in the industry, with some headlines promising AI will speed drugs to market while others warn it could waste resources. Thomas M. Kaiser, a medicinal chemist,…
    BioSpace · 13h agoNeutral↗ source
  • Novartis' del-desiran fails primary endpoint in phase 3 Harbor trial for myotonic dystrophy type 1
    Novartis announced that its experimental therapy del-desiran did not meet the primary endpoint in the phase 3 Harbor trial, which evaluated improvement in video hand opening time in patients with m…
    Fierce Biotech · 15h agoNegative readoutNegative↗ source
  • Four CDMOs to watch as biopharma outsourcing grows
    The article lists four contract development and manufacturing organizations (CDMOs) that biopharma companies can partner with as demand for external development and manufacturing rises. Lonza, bas…
    BioSpace · 14h agoNeutral↗ source
  • Inhibrx CEO says progression-free survival data leave ‘no question’ about OX40 agonist’s durability
    Inhibrx Biosciences’ CEO has argued that the 9.6 months of progression-free survival demonstrated by its OX40 agonist in a phase 2 study has proven the therapy’s durability in treating head and nec…
    Fierce Biotech · 18h ago↗ 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 · 1d agoNegative readoutNegative↗ source
  • BrainChild Bio masterminds $116M series A for CAR-T's pivotal push in pediatric brain cancer
    A startup spawned from Seattle Children’s Hospital has raised a $116 million series A to advance cell therapies for devastating childhood brain tumors.
    Fierce Biotech · 1d agoNeutral↗ 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 · 19h agoLayoffsNegative↗ source