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252 stories matching this filter · ← front page

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  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 17h agoDealPositive↗ source
  • Merck and Moderna’s personalized mRNA vaccine shows longer recurrence-free survival in phase 3 melanoma trial
    Merck and Moderna reported that their individualized mRNA cancer vaccine, given together with Keytruda, extended the time patients remained free of melanoma recurrence in a late-stage study. The p…
    Fierce Biotech · 1d agoPositive readoutPositive
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Infectious Disease345
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  • Third patient dies in Chinese trial of RiboX Therapeutics' experimental genetic therapy
    A patient with an autoimmune disease died after receiving an experimental genetic medicine from RiboX Therapeutics, a Shanghai‑based biotech startup. The death marks the third fatality reported in…
    Endpoints · 1d agoNegative↗ source
  • Argenx reports positive Phase 3 results for Vyvgart Hytrulo in myositis
    Argenx announced that its subcutaneous formulation of Vyvgart, named Vyvgart Hytrulo, met the primary endpoint in a late‑stage Phase 3 trial in patients with myositis. The trial combined participa…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 2d agoNegative readoutNegative↗ source
  • Biotech raises $820M to bring China-sourced immunology drug to market via reverse merger
    A biotech company has secured $820 million in investor commitments this month to bring its immunology drug, developed in China, to public markets. The funding will be used to complete a reverse me…
    Endpoints · 2d agoDealPositive↗ source
  • Argenx reports Phase 3 success for Vyvgart Hytrulo in autoimmune myositis, despite subgroup shortfall
    Argenx announced that its subcutaneous antibody Vyvgart Hytrulo achieved its primary endpoint in a Phase 3 trial for autoimmune myositis, a rare group of inflammatory muscle diseases. The trial de…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • AstraZeneca halts phase 3 lung cancer trial of bispecific antibody volrustomig after it falls short of Keytruda
    AstraZeneca stopped its phase 3 trial of the bispecific antibody volrustomig in metastatic non‑small cell lung cancer after interim data suggested the regimen would not meet the study's primary goa…
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 2d agoCRLNegative↗ source
  • Evaxion drops solid tumor vaccine program to prioritize brain cancer vaccine candidate
    Evaxion Biotech announced it has discontinued development of its next‑generation solid tumor vaccine, EVX‑03, and will redirect resources toward a brain cancer vaccine candidate developed with Duke…
    Fierce Biotech · 2d agoNeutral↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 5d agoRegulatoryPositive↗ source
  • Two undisclosed gene-therapy deaths raise doubts about China's fast-track trial pathway
    Two recent deaths in China’s early‑stage gene‑therapy trials have drawn international attention. Both patients suffered severe immune reactions after receiving high‑dose viral vector treatments, an…
    Fierce Biotech · 5d agoRegulatoryNegative↗ source
  • BioCryst to rely on external partnerships after ending internal discovery programs
    BioCryst Pharmaceuticals CEO Charlie Gayer told Fierce that the company remains committed to science and research even as it shuts down its internal discovery efforts. Earlier this year the firm’s…
    Fierce Biotech · 5d agoNeutral↗ source
  • Zealand Pharma sells its rights to Takeda's rusfertide for $100 million ahead of FDA decision
    Zealand Pharma has agreed to sell its economic interest in rusfertide, a peptide drug being developed by Takeda and Protagonist Therapeutics, for $100 million. The transaction comes as the FDA rev…
    Fierce Biotech · 6d agoDealNeutral↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 7d agoDealPositive↗ source
  • Boulevard Bio launches with $65 million to develop bispecific antibodies for IgA nephropathy and other autoimmune diseases
    Boulevard Bio, a new biotech co-founded by autoimmune researcher Georg Schett and former Sanofi CSO Frank Nestle, announced its launch on Wednesday with $65 million in funding. The company’s first…
    BioPharma Dive · 7d agoDealPositive↗ source
  • Eli Lilly fronts $2 billion for vaccine biotech deals as Infinimmune secures $75 million funding
    Eli Lilly announced it has paid $2 billion up front as part of its ongoing strategy to acquire vaccine‑focused biotechnology companies, a portion of a larger deal that could total up to $3.8 billio…
    Endpoints · 8d agoDealPositive↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Infinimmune secures $75 million Series A to develop longer-lasting eczema antibody therapies
    Infinimmune, a biotech based in Alameda, California, announced on Tuesday that it has closed a $75 million Series A financing round. The capital will support the development of its first two clinic…
    BioPharma Dive · 8d agoDealPositive↗ source
  • Deerfield-backed Boulevard Bio raises $65 million and unveils three autoimmune drug candidates
    Boulevard Bio, a New York‑based biotech focused on B‑cell biology, announced it has emerged from stealth with $65 million in financing from Deerfield Management. The funding supports the developmen…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Scribe Therapeutics launches first gene‑editing IPO in over two years, targeting high‑cholesterol gene
    Scribe Therapeutics, a gene‑editing biotech based in California, announced its initial public offering, the first for a CRISPR‑focused company in more than two years. The company, founded by resea…
    BioPharma Dive · 9d agoDealPositive↗ source
  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 12d agoDealPositive↗ source
  • Ensoma cuts staff again to focus on lead gene therapy for rare immune disease
    Boston‑based biotech Ensoma announced another round of layoffs as it narrows its efforts to its sole clinical candidate, EN‑374, aimed at treating X‑linked chronic granulomatous disease (X‑CGD). E…
    Fierce Biotech · 12d agoLayoffsNegative↗ source
  • Replimune's oncolytic virus therapy Tudriqev receives FDA accelerated approval for advanced melanoma
    The U.S. Food and Drug Administration has granted approval to Replimune's melanoma treatment, ending a series of earlier rejections after an advisory panel advocated for the drug. The therapy, pre…
    BioPharma Dive · 13d agoApprovalPositive↗ source