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Kyverna’s autoimmune CAR‑T posts registrational success — FDA filing planned
Kyverna Therapeutics reported positive registrational results for its patient‑specific CD19 CAR‑T in stiff person syndrome (SPS), showing improvements in mobility and stiffness that met primary...
Abpro and Celltrion file IND for HER2×CD3 T‑cell engager — first‑in‑human ahead
Abpro Holdings and Celltrion announced submission of an IND to the U.S. FDA for ABP‑102 (CT‑P72), a HER2×CD3 T‑cell engager designed for HER2‑positive solid tumors. Pending clearance, a Phase I...
FDA clears Enhertu combo for first‑line HER2+ metastatic breast cancer
The U.S. FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for first‑line treatment of unresectable or metastatic HER2‑positive breast...
Ultrasound‑activated polypeptide primes innate immunity — sono‑adjuvant shows promise
Researchers published a Nature Communications paper describing a sonically activated polypeptide‑based 'sono‑adjuvant' that, when triggered by ultrasound, modulates innate immunity and enhanced...
Valinor raises $13M seed to power multiomics ML for smarter trials
Valinor, an AI biotech developing multiomics‑trained machine‑learning models to improve clinical trial design and patient responder identification, closed a $13 million seed round led by CRV,...
Immunome’s oral therapy slashes desmoid progression 84% – NDA planned
Immunome announced positive Phase III data showing its oral gamma‑secretase inhibitor, varegacestat, reduced the risk of disease progression or death by 84% in patients with progressing desmoid...
Sanofi’s BTK hopes dented — Phase III miss and review delay
Sanofi disclosed that its Bruton’s tyrosine kinase inhibitor tolebrutinib failed the Phase III Perseus study in primary progressive multiple sclerosis (PPMS), and the company said the drug’s U.S....
Kyverna’s CAR‑T delivers registrational win in stiff person syndrome – FDA path cleared
Kyverna Therapeutics reported positive registrational data from a pivotal study of its patient‑specific CD19 CAR‑T therapy in stiff person syndrome (SPS), a rare autoimmune movement disorder. The...
FDA greenlights Enhertu combo for first‑line HER2 breast cancer
The FDA expanded the label for AstraZeneca and Daiichi Sankyo’s antibody‑drug conjugate Enhertu, clearing its use in combination with pertuzumab as a first‑line therapy for unresectable or...
Chai Discovery raises $130M — AI antibody design scales
AI‑drug developer Chai Discovery closed a $130 million Series B round at roughly a $1.3 billion valuation to scale its Chai‑2 generative antibody platform. The company released preprint data...
XOMA to acquire Generation Bio — ctLNP delivery and Moderna ties in play
XOMA Royalty announced an agreement to acquire Generation Bio in a cash tender offer with contingent value rights (CVRs) attached, bringing Generation Bio’s cell‑targeted lipid nanoparticle...
Postsurgical lymph fluid outperforms plasma for MRD in head‑and‑neck cancer — Droplet validates
Droplet Biosciences and academic collaborators published a study in Clinical Cancer Research validating postoperative lymph drain fluid as a sample for circulating tumor DNA (ctDNA) detection of...
ctDNA edges toward clinic — bladder and breast studies show promise, call for more trials
Two strands of clinical work this week reinforced circulating tumor DNA’s (ctDNA) expanding role: exploratory ctDNA‑guided therapy data in muscle‑invasive bladder cancer and conference analyses...
Adaptive licenses TCR discovery to Pfizer — deal could top $890M
Adaptive Biotechnologies struck two non‑exclusive agreements with Pfizer granting the pharma access to Adaptive’s T‑cell receptor discovery platform and large‑scale TCR‑antigen mapping data. One...
Year‑end biobucks: Sanofi, Yarrow sign billion‑dollar licensing pacts
Two major year‑end licensing deals reshaped late‑2025 headlines: Sanofi paid $80 million upfront and up to $1.04 billion in biobucks to license ADEL’s tau‑targeting antibody ADEL‑Y01 for...
Immunome Phase 3 Win: Desmoid drug cuts progression 84%
Immunome reported decisive Phase III results showing its oral gamma‑secretase inhibitor reduced the risk of disease progression or death by 84% in patients with progressing desmoid tumors. The...
Sanofi licenses ADEL’s tau antibody: $80M now, $1.04B upside
Sanofi moved to license ADEL Inc.’s tau‑targeting antibody ADEL‑Y01, paying $80 million up front with the deal carrying potential total payments up to $1.04 billion. ADEL‑Y01 is a humanized...
Genentech–Caris: $1.1B cancer collaboration to mine targets
Genentech struck a multi‑year collaboration with Caris Life Sciences to accelerate discovery of drug targets and biomarkers across solid tumors, a deal valued at up to $1.1 billion including...
XOMA moves to buy Generation Bio: tender offer, CVR attached
XOMA Royalty announced an agreement to acquire Generation Bio in a cash tender offer around $4.29 per share and to provide contingent value rights that capture potential upside from Generation...
Kyverna close to first FDA CAR‑T approval for an autoimmune disease
Kyverna reported a registrational trial readout showing its personalized CD19 CAR‑T improved mobility and reduced stiffness in stiff person syndrome (SPS), a rare autoimmune disorder. The Phase...