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FDA pauses Daiichi‑Merck ADC program — safety probe after patient deaths
The Food and Drug Administration placed a partial clinical‑trial hold on Daiichi Sankyo and Merck & Co.’s global Phase 3 program for their investigational antibody‑drug conjugate after an...
Takeda’s $4B TYK2 bet clears Phase 3 — filings expected in 2026
Takeda reported that zasocitinib, the TYK2 inhibitor it acquired in a multibillion‑dollar deal, met primary and key secondary endpoints in two Phase 3 trials for plaque psoriasis. The company said...
CEPI backs Moderna’s H5 pandemic shot — $54M to push Phase 3
The Coalition for Epidemic Preparedness Innovations agreed to fund Moderna’s mRNA‑1018 H5 avian influenza vaccine with up to $54.3 million to support a Phase 3 study after U.S. government funding...
Lilly’s oral GLP‑1 orforglipron sustains weight loss — fast FDA review likely
Eli Lilly reported positive top‑line results from a Phase 3 maintenance trial showing its oral GLP‑1 candidate orforglipron maintained weight loss over 52 weeks after prior treatment with...
MIT mRNA liver therapy rejuvenates aged immunity — translational promise
MIT researchers demonstrated that delivering mRNAs encoding key trophic factors to the liver transiently restored diverse naive and stem‑like T‑cell populations in aged mice, improving vaccine...
Engineered dendritic cells capture tumor EVs — EPFL reports robust antitumor activity
Researchers at EPFL published strategies for engineering dendritic cell progenitors to express extracellular‑vesicle internalizing receptors (EVIR) and an instructive chimeric antigen receptor...
VolitionRx adapts ChIP‑seq for liquid biopsy — Capture‑Seq seeks partners
VolitionRx published a preprint describing a ChIP‑seq‑based liquid biopsy method, Capture‑Seq, that isolates cell‑free DNA fragments bound to CTCF protein (cfCTCF‑DNA) from plasma to identify...
Insmed’s expansion bid falters — brensocatib fails Phase 2b, company pivots
Insmed disclosed that brensocatib (Brinsupri) failed a Phase 2b study in chronic rhinosinusitis without nasal polyps, ending a recent run of positive news and triggering a near‑term share price...
DBV’s Viaskin peanut patch clears Phase 3 — BLA planned next year
DBV Technologies reported positive top‑line results from the pivotal Phase 3 Vitesse study: Viaskin Peanut met its primary endpoint in children aged 4–7, with 46.6% meeting responder criteria...
Addition Therapeutics raises $106.5M — all‑RNA LNP ‘jumping gene’ platform advances
Addition Therapeutics emerged from stealth with a $106.5 million financing to advance its Precise RNA‑Mediated Insertion of Transgenes (PRINT) platform, an all‑RNA, lipid nanoparticle‑based...
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...