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Patient deaths prompt partial hold: Daiichi–Merck ADC program halted
U.S. regulators and sponsors paused a global Phase 3 antibody‑drug conjugate (ADC) program after an unexpectedly high number of on‑study deaths. Daiichi Sankyo and Merck stopped enrollment and the...
CEPI plugs funding gap: Moderna’s H5 mRNA vaccine moves to Phase 3
The Coalition for Epidemic Preparedness Innovations (CEPI) agreed to fund up to $54.3 million to advance Moderna’s mRNA‑1018 H5 influenza vaccine into Phase 3 testing. The grant arrives after U.S....
Lilly’s oral GLP‑1: Orforglipron shows maintenance benefit – fast FDA review in play
Eli Lilly reported Phase 3 Attain‑Maintain results showing orforglipron helped patients maintain weight after prior use of injectable GLP‑1 therapies, meeting primary and key secondary endpoints....
Takeda’s $4B TYK2 bet pays off – zasocitinib posts Phase 3 wins
Takeda announced that zasocitinib met co‑primary and key secondary endpoints in two Phase 3 psoriasis trials, delivering superiority against placebo and Amgen’s Otezla on established...
GSK wins FDA nod: twice‑yearly IL‑5 biologic cleared for severe asthma
The U.S. Food and Drug Administration approved GSK’s depemokimab (Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The agency cleared an...
Liver‑targeted mRNA revives aged immunity: transient reprogramming boosts T cells
MIT researchers demonstrated that delivering mRNAs encoding trophic factors (DLL1, FLT3L, IL‑7) to hepatocytes can transiently restore thymic‑like support and enlarge the naive T‑cell pool in aged...
Addition Therapeutics emerges with printing‑scale gene insertion and funding
Addition Therapeutics unveiled its PRINT platform for RNA‑mediated insertion of transgenes and disclosed new funding to advance all‑RNA, lipid nanoparticle‑based gene therapies. The company, spun...
Chai Discovery lands $130M Series B to scale AI antibody design
AI antibody designer Chai Discovery closed a $130 million Series B to commercialize its Chai‑2 generative platform for de novo antibody design. The company reported double‑digit experimental...
Degrader‑ADC financing: Orum nets $100M for degrader‑antibody conjugates
Orum Therapeutics closed about $100 million (146 billion won) to advance its degrader‑antibody conjugate (DAC) platform and lead oncology candidates, shifting focus after safety issues halted a...
Capture‑Seq: VolitionRx adapts ChIP‑Seq for ultrasensitive liquid biopsy signals
Epigenetics company VolitionRx published a preprint describing 'Capture‑Seq,' a ChIP‑Seq adaptation isolating ultrashort cell‑free DNA fragments bound to the transcription factor CTCF, producing a...
Takeda’s TYK2 drug zasocitinib wins two Phase 3 trials – 2026 U.S. filing planned
Takeda reported that zasocitinib, the TYK2 inhibitor it acquired in a $4 billion deal, met co‑primary and top secondary endpoints in two Phase 3 psoriasis trials. The company said the oral therapy...
FDA clears GSK’s twice‑yearly asthma biologic Exdensur – two injections a year
The FDA approved GSK’s depemokimab, branded Exdensur, as an add‑on maintenance treatment for patients aged 12 and older with severe eosinophilic asthma. The agency’s decision follows positive...
DBV’s Viaskin peanut patch succeeds in Phase 3 Vitesse... BLA planned H1
DBV Technologies announced positive top‑line results from its pivotal Phase 3 Vitesse trial: 46.6% of children treated with the Viaskin peanut patch met the trial’s responder criteria after 12...
Moderna taps CEPI to bankroll H5 pandemic vaccine Phase 3 – CEPI plugs $54M gap
Moderna secured CEPI as a new funding backer to support a Phase 3 trial of its mRNA‑1018 H5 pandemic influenza vaccine after U.S. government funding was withdrawn. The Coalition for Epidemic...
Addition Therapeutics emerges with PRINT LNP gene‑insertion platform and $106.5M
Addition Therapeutics emerged from stealth to commercialize a Precise RNA‑Mediated Insertion of Transgenes (PRINT) platform that uses retrotransposon biology delivered in lipid nanoparticles to...
Chai Discovery lands $130M Series B – AI designed antibodies at scale
Chai Discovery closed a $130 million Series B to expand its AI‑driven de novo antibody design platform, Chai‑2. The company reported double‑digit success rates in zero‑shot antibody design...
Orum Therapeutics banks $100M to push degrader‑antibody conjugates toward clinic
Orum Therapeutics raised roughly $100 million (146 billion Korean won) to advance a pipeline that fuses antibody targeting with protein‑degrading payloads — ‘degrader‑antibody conjugates’ — and to...
Personalis’ NeXT Personal ctDNA assay predicts immunotherapy response across solid tumors
A Phase I study published in Clinical Cancer Research showed that Personalis’ NeXT Personal MRD assay — a tumor‑informed, whole‑genome sequencing ctDNA test — accurately predicted immunotherapy...
Regulators pivot: FDA signals looser RWE rules – Senate readies Biosecure Act curbs on Chinese suppliers
The U.S. FDA announced a less restrictive stance on the use of real‑world evidence (RWE) in device and drug application reviews, saying new guidance will permit submissions that use de‑identified...
Zwitterionic ionizable lipid LNPs reduce reactogenicity and ramp mRNA antigen expression
Researchers reported a novel zwitterionic ionizable lipid for mRNA‑LNP formulations that improved antigen expression while reducing inflammatory reactogenicity in preclinical cancer vaccine...