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  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Merck's sac-TMT shows promise in Chinese Phase 3 lung cancer trial, may replace chemo
    Merck and its Chinese partner Kelun-Biotech reported that the antibody-drug conjugate sac-TMT slowed disease progression better than a standard chemotherapy regimen in a Phase 3 trial conducted in…
    BioPharma Dive · 1mo agoPositive readoutPositive
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↗ source
  • Celcuity’s breast cancer therapy gets FDA approval as new CBER chief outlines biotech priorities
    Celcuity announced that its first breast cancer drug has been approved by the U.S. Food and Drug Administration, marking the company’s initial market entry in oncology. The announcement coincided…
    STAT · 1mo agoApprovalPositive↗ source
  • J&J shares fall 3% as oncology sales miss forecasts, while AstraZeneca invests $600M in lung cancer drug
    Johnson & Johnson’s stock slipped about 3% on Wednesday even though the company raised its full‑year sales outlook. In its latest quarterly earnings release the firm said revenue in its innovative…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 1mo agoDealPositive↗ source
  • Study reveals how Epstein-Barr virus triggers immune response in multiple sclerosis
    A study published in Science Translational Medicine describes how infection with Epstein-Barr virus (EBV) initiates the immune reactions that lead to inflammation and nerve damage in people with mu…
    STAT · 1mo agoPositive↗ source
  • Attovia Therapeutics and Braveheart Bio announce plans for biotech IPOs amid market upswing
    Attovia Therapeutics and Braveheart Bio disclosed on Tuesday that they intend to go public, joining a recent wave of large biotech offerings. Attovia, which was spun out of Alamar Biosciences in 2…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Mwyngil Therapeutics launches obesity program that avoids GLP-1 pathway
    Mwyngil Therapeutics, a newly formed biotech startup, is pursuing obesity treatments that do not target the GLP-1 receptor, a pathway that has dominated recent weight-loss drug development. CEO Lu…
    STAT · 1mo agoNeutral↗ source
  • Ebola outbreak in eastern Congo accelerates, 80% of new cases from unknown transmission chains
    WHO emergencies chief Chikwe Ihekweazu said the Ebola outbreak in eastern Congo is outpacing response efforts, noting that many recent deaths occurred in communities without reaching health facilit…
    STAT · 1mo agoNegative↗ source
  • Avere Therapeutics to go public via reverse merger, secures $320M to advance long-acting psoriasis pill
    Avere Therapeutics, a privately held immunology drug developer, announced a plan to become a public company through a reverse merger with NextCure. The transaction includes $320 million in new cap…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Biogen's tau-targeting Alzheimer's drug shows cognitive slowing in mid-stage trial
    Biogen reported results from its mid-stage "Celia" trial testing the experimental tau-targeting antibody BIIB080 in patients with early Alzheimer's disease. The study compared three dose levels of…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Innovent Biologics partners with Spero to advance autoimmune drug candidate beyond GSK antibiotic
    Innovent Biologics has announced a new partnership with Spero, a smaller biopharma firm, to develop an autoimmune drug candidate originating from Suzhou, China. The collaboration follows a series…
    Endpoints · 1mo agoDealPositive↗ source
  • Former FDA toxicologist says agency approved Zyn nicotine pouches without fully knowing their composition
    Former FDA toxicologist Christy Leppanen alleges the agency authorized Zyn nicotine pouches without complete safety data on the pouch material. Leppanen, who led a microplastics exposure project a…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Anthropic launches Claude Science AI platform for biotech labs in Kendall Square
    Anthropic has introduced Claude Science, an application that tailors its large language model for use in biopharma research laboratories. The tool is being positioned for the Kendall Square biotech…
    STAT · 1mo agoNeutral↗ source
  • Former Akero executives team up with Fairmount to launch new immunology company
    The former executive team of Akero Therapeutics, which was recently acquired by Novo Nordisk, has announced the formation of a new immunology-focused company. They are partnering with investment fi…
    STAT · 1mo agoNeutral↗ source
  • Cyclospora infections hit record high in 2026, Michigan officials suspect lettuce as source
    Infections caused by the parasite Cyclospora have surged to a record level in 2026, with more than 30 states reporting cases that now exceed the previous U.S. high of about 4,700 set in 2019. The…
    STAT · 1mo agoNegative↗ source
  • Q32 Bio’s alopecia drug bempikibart meets Phase 2 goal, driving shares up 80%
    Q32 Bio reported that its experimental alopecia areata therapy, bempikibart, achieved the primary endpoint in the second part of a Phase 2 trial. Two‑fifths of participants grew enough hair to cove…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Biotech venture funding hits $9.1 billion in H1 2026, but small startups lag behind
    Venture capital funding for biotech startups surged in the first half of 2026, with nearly 70 companies securing more than $9.1 billion, according to BioPharma Dive data. The bulk of the money cam…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Ipsen's Dysport shows positive Phase 3 results in migraine, Tarsus acquires iRenix for $75M
    Ipsen reported that its injectable neurotoxin Dysport met the primary endpoint in a Phase 3 trial aimed at reducing monthly migraine days. The trial demonstrated a statistically significant reduct…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Lung transplants boost survival for select stage 4 lung cancer patients, study finds
    Northwestern Medicine surgeons and oncologists performed double lung transplants on a small group of stage 4 lung cancer patients whose disease was confined to the lungs. The JAMA study compared 1…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Europe to Speed Review of RevMed Drug as Concerns Rise Over Kailera GLP-1 Pill and FDA Clears Vera Therapy
    European regulators said they will move more quickly to assess RevMed's investigational drug, aiming to shorten the evaluation timeline. Separate reports highlighted that recent data from Kailera'…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA approves Vera Therapeutics' Trutakna for IgA nephropathy, pricing set at $425,000 per year
    The U.S. Food and Drug Administration has granted approval to Trutakna, a new therapy from Vera Therapeutics, for the treatment of IgA nephropathy. IgA nephropathy is a kidney disorder where immun…
    STAT · 2mo agoApprovalPositive↗ source
  • Longevity entrepreneur Bryan Johnson reveals he has autoimmune gastritis, a hard-to-diagnose stomach disease
    Bryan Johnson, known for his longevity ventures, announced on X that he has been diagnosed with autoimmune gastritis. The condition is a chronic inflammatory disease where antibodies attack stomac…
    STAT · 2mo agoNeutral↗ source
  • Vera Therapeutics receives accelerated approval for Trutakna to treat IgA nephropathy
    Vera Therapeutics announced that its fusion protein atacicept, branded as Trutakna, has been granted accelerated approval by the FDA for the treatment of immunoglobulin A nephropathy, a chronic aut…
    Endpoints · 2mo agoApprovalPositive↗ source