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  • Spanish biotech Ona Therapeutics secures $86.6 million Series B to advance new ADCs for breast and colorectal cancer
    Ona Therapeutics, a Barcelona‑based biotechnology startup, announced a Series B financing round that raised roughly $86.6 million. The new capital will fund the launch of two antibody‑drug conjuga…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Drug makers and patient groups call on FDA to suspend fast‑track voucher program
    The FDA held a town‑hall listening session on its Commissioner’s National Priority Voucher program, hearing from 17 speakers that included patient advocates, pharmaceutical companies and academic r…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • Otsuka's Voyxact reduces kidney function decline in IgA nephropathy but falls short of expectations in Phase 3
    Otsuka reported Phase 3 trial results for its drug Voyxact in patients with IgA nephropathy, a chronic autoimmune kidney disease. In the study, patients receiving Voyxact experienced an annualized…
    STAT · 4mo agoNegative readoutNeutral↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Scientists identify previously unknown HIV reservoir in the body
    Scientists have reported the discovery of a new location where HIV can hide within the human body. The finding expands the list of known viral reservoirs and suggests that the virus may persist in…
    STAT · 4mo agoNeutral↗ source
  • HHS says Americans with high-risk Ebola exposure can receive experimental antibody MBP-134 from Mapp Biopharma
    HHS announced that U.S. citizens who have had high-risk exposure to Ebola in the ongoing Central African outbreak will be eligible to receive an experimental antibody therapy. The treatment, ident…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Revolution Medicines' pancreatic cancer drug sparks standing ovation on biotech podcast
    The latest episode of STAT’s "The Readout LOUD" podcast highlighted a recent data presentation on Revolution Medicines’ pancreatic cancer candidate, daraxonrasib. Oncologists in the audience respo…
    STAT · 4mo agoNeutral↗ source
  • Study highlights gaps in male puberty research and links timing to future health risks
    Researchers note that most knowledge about puberty comes from studies in girls, leaving a substantial gap in understanding how the onset of puberty in boys affects later health. Emerging evidence…
    STAT · 4mo agoNeutral↗ source
  • Bipartisan House bill would require security review of U.S. biotech investments in China
    A bipartisan group of Representatives introduced legislation on Tuesday that would expand the Committee on Investment and National Security (COINS) Act to cover biotechnology. The bill, called the…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Alnylam inks up to $2 billion AI partnership with Inceptive Nucleics for RNAi drug discovery
    Alnylam announced a three-year strategic collaboration with Inceptive Nucleics to develop AI foundation models for RNAi therapeutics. The agreement is valued at up to $2 billion, with an initial $…
    STAT · 4mo agoDealPositive↗ source
  • NewLimit raises $435M Series C to launch epigenetic anti-aging therapy, while Lilly signs GLP-2 obesity drug deal
    Longevity startup NewLimit announced a $435 million Series C financing, one of the largest biotech rounds this year. The round was led by Founders Fund and included investors such as Thrive Capital…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Legend Biotech shares jump 40% after promising early CAR-T data in Non-Hodgkin’s lymphoma
    Shares of Legend Biotech rose more than 40% after the company released early results from its in vivo CAR‑T therapy targeting Non‑Hodgkin’s lymphoma. The data showed encouraging activity and a mana…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Cigna to End Coverage of GLP-1 Weight-Loss Drugs Wegovy and Zepbound for Employees Starting July 1
    Cigna announced it will stop covering GLP-1 weight-loss medications for its employee health plan, effective July 1. The decision affects drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepboun…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Trump administration's new Medicaid work-requirement rules surprise states and patients
    Medicaid leaders and advocates say they are shocked by the Trump administration's latest directives that tighten work‑requirement rules for the program, a shift from the tone of earlier federal sta…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Rising AI battle between hospitals and insurers drives soaring medical bills, says pediatric cardiologist
    Darshak Sanghavi, a pediatric cardiologist and chief medical officer of Machinify, writes an opinion piece about an emerging AI conflict between health providers and insurers over patient records a…
    STAT · 4mo agoNegative↗ source
  • Roche reports narrow failure of breast cancer pill in Phase 3 trial at ASCO
    Roche updated investors and the oncology community that its experimental breast cancer oral therapy did not meet its primary endpoint in a pivotal Phase 3 study. The data, presented at the America…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • AbiVax shares plunge as safety concerns shadow strong ulcerative colitis trial results
    AbiVax reported Phase 3 data for its experimental therapy obefazimod in patients with moderately to severely active ulcerative colitis. Two dose levels achieved placebo‑adjusted clinical remission…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • ASCO 2026 Highlights Bispecific Antibodies, ADCs and New Advances in RAS-Targeted and Prostate Cancer Therapies
    The meeting featured a lively comparison of bispecific antibodies and antibody-drug conjugates as leading modalities in oncology. Researchers presented data suggesting that targeting mutant RAS pr…
    BioPharma Dive · 4mo agoPositive↗ source
  • Celcuity's gedatolisib trial cuts death risk but misses investor expectations
    Celcuity reported data from its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in HR‑positive, HER2‑negative breast cancer with PIK3CA mutations. The trial enrolled 350 patients who had progresse…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Longevity startup NewLimit secures $435 million Series C as it prepares first liver drug trial
    NewLimit, a longevity‑focused biotech founded in 2021, announced a Series C financing that brought in $435 million, pushing its valuation to about $3.1 billion. The round was led by Founders Fund…
    STAT · 4mo agoDealPositive↗ source
  • Radiopharmaceutical shows promise after Pluvicto; Vera Therapeutics gains FDA agreement to speed IgA nephropathy data analysis
    A new radiopharmaceutical is generating interest for use after patients have completed Pluvicto therapy, suggesting a potential follow‑on treatment option. Abivax reported encouraging results from…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Eli Lilly warns 340B hospitals to submit claims data within five days or lose price discounts
    Eli Lilly has given roughly 50 hospitals that participate in the federal 340B drug discount program a five‑day deadline to provide comprehensive claims data. The company says that if the data are n…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Trump administration releases Medicaid work-requirement rules, prompting state compliance challenges
    The Morning Rounds newsletter highlighted several health‑policy developments, notably new Medicaid work‑requirement rules and fast‑tracked funding for experimental Ebola vaccines. The Trump admini…
    STAT · 4mo agoRegulatoryNeutral↗ source