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164 stories matching this filter · ← front page

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  • Caldera and Evommune secure China licensing agreements for autoimmune drug assets
    Caldera and Evommune announced they have entered licensing agreements with Chinese partners to bring their autoimmune drug programs to the Chinese market. The deals come as the biopharma sector is…
    Endpoints · 3d agoDealPositive↗ source
  • T-Therapeutics raises $133 million from Sanofi, J&J, Merck KGaA and Eli Lilly for TCR cancer and autoimmune programs
    T-Therapeutics, a UK biotech focused on T-cell receptor therapies for cancer and autoimmune diseases, announced it has raised $133 million in financing. The round is led by Sanofi with participati…
    Endpoints · 4d agoDealPositive↗ source
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  • Minghui Pharma sells Japanese rights to its Phase 3 thyroid eye disease drug for $110 million upfront
    Minghui Pharmaceutical, a Shanghai‑based biotech, has agreed to transfer the Japanese commercial rights for its late‑stage thyroid eye disease candidate to a specialty pharmaceutical company. The…
    Endpoints · 5d agoDealPositive↗ source
  • Sanofi halts development of Nurix's STAT6 degrader program
    Sanofi announced it will stop work on an experimental drug that targets STAT6, a protein involved in immune signaling. The compound, known as SAR448272 and developed in partnership with Nurix, was…
    Endpoints · 4d agoNegative↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 9d agoApprovalPositive↗ source
  • Aspen Neuroscience and Bambusa raise $310M combined in IPOs
    Aspen Neuroscience, a biotech focused on cell therapy for Parkinson's disease, announced it will raise about $141 million through its initial public offering scheduled for Friday. Bambusa, a start…
    Endpoints · 10d agoDealPositive↗ source
  • Gilead places CAR-T program on partial hold after ICANS cases; Agios delays PDUFA submission
    Gilead announced a partial clinical hold on its CAR-T therapy after several patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). The hold will pause enrollment and…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • Artiva Biotherapeutics to cease operations after two deaths in autoimmune cell therapy trials
    Artiva Biotherapeutics announced it will wind down and lay off nearly all staff following two patient fatalities in its autoimmune cell therapy trials. The deaths occurred during clinical testing…
    Endpoints · 12d agoNegative↗ source
  • Bristol Myers reports patient death in autoimmune CAR-T trial and explains summer pause
    Bristol Myers Squibb disclosed that a participant in its autoimmune CAR-T cell therapy study has died. The company said the death occurred during the trial and is under investigation, with details…
    Endpoints · 16d agoNegative↗ source
  • Bristol Myers Squibb identifies cause of safety signal in lupus CAR‑T trial
    Bristol Myers Squibb's cell therapy division is confronting ongoing safety challenges with its autoimmune CAR‑T program. The company says it has pinpointed the underlying cause of the safety signa…
    Endpoints · 16d agoRegulatoryNeutral↗ source
  • Roivant's autoimmune drug brepocitinib succeeds in two pivotal trials, paving way for 2027 filing
    Roivant Sciences said its autoimmune drug brepocitinib met primary goals in two pivotal studies. The trials, which evaluated the drug in separate autoimmune indications, showed statistically signi…
    Endpoints · 18d agoPositive readoutPositive↗ source
  • Pfizer halts Phase 2 trial of PF-06835375 in primary immune thrombocytopenia
    Pfizer announced that it is stopping its Phase 2 study of the experimental program PF-06835375, which was being evaluated in patients with primary immune thrombocytopenia, a rare autoimmune blood d…
    Endpoints · 19d agoNegative readoutNegative↗ source
  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 20d agoApprovalPositive↗ source
  • Osivax shifts to combination strategy after Phase 2b flu vaccine setback
    Osivax, a French biotech, reported that its lead influenza vaccine candidate did not meet primary endpoints in a Phase 2b study. The trial, which evaluated the vaccine as a standalone product, sho…
    Endpoints · 24d agoNegative readoutNegative↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 25d agoApprovalPositive↗ source
  • Argenx halts Phase 3 Sjögren's trial as celiac disease data brings mixed results
    Argenx disclosed on Thursday that it is ending its Phase 3 trial in Sjögren's syndrome after the study failed to meet its primary endpoint. The decision came alongside the release of encouraging r…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Nuvig Therapeutics halts Phase 2 trial of NVG-2089 in chronic inflammatory demyelinating polyneuropathy
    Nuvig Therapeutics announced it is terminating one of its two ongoing clinical programs, a Phase 2 study of its candidate NVG-2089. The trial was designed to evaluate NVG-2089 in patients with chr…
    Endpoints · 1mo agoCRLNegative↗ source
  • Novartis pays $575 million upfront for worldwide rights to Abogen’s CD19xCD3 mRNA T-cell engager
    Novartis announced it will pay Abogen Biosciences $575 million upfront for exclusive worldwide rights to its lead early‑stage CD19xCD3 mRNA T‑cell engager. The agreement gives Novartis access to t…
    Endpoints · 1mo agoDealPositive↗ source
  • Sanofi to pay $1 billion upfront to expand antibody partnership with Regeneron
    Sanofi announced it will provide Regeneron with a $1 billion upfront payment to broaden their existing antibody collaboration. The agreement is timed as the patent protection for Dupixent, the joi…
    Endpoints · 1mo agoDealNeutral↗ source
  • Former Spark co-founder Steven Altschuler launches new immune-resetting biotech
    Steven Altschuler, who co-founded Spark Therapeutics, has announced the formation of a new biotech that aims to reset the immune system. The venture is positioned to address autoimmune diseases, a…
    Endpoints · 1mo agoDealPositive↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 1mo agoApprovalNeutral↗ source
  • Kyverna reports positive one-year CAR-T results for rare stiff person syndrome, supporting FDA filing
    Kyverna Therapeutics announced that its CAR-T therapy for stiff person syndrome showed positive results after one year of treatment. The trial involved patients with the rare autoimmune disorder,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Cue Biopharma's chronic hives drug clears Phase 2 trial, first immunology data after cancer pivot
    Cue Biopharma announced that its candidate for chronic spontaneous urticaria successfully completed a Phase 2 trial in China. The trial marks the company's first clinical data since it shifted its…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Two more biotechs, Marea and North Immunology, do reverse mergers
    The reverse merger party is still buzzing. This time, it's a cardio and endocrine startup with two drugs in Phase 2 and a biotech working on a long-acting immunology and inflammation (I&I) drug. Mi…
    Endpoints · 1mo ago↗ source