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Sanofi’s MS bet falters — tolebrutinib Phase 3 misses primary endpoint
Sanofi reported that tolebrutinib, its BTK inhibitor acquired in a prior buyout, failed to meet the primary endpoint in the phase III Perseus trial for primary progressive multiple sclerosis, the...
Immunome’s phase‑3 win slashes desmoid progression — NDA next
Immunome reported positive topline results from a registrational Phase 3 trial showing its oral gamma‑secretase inhibitor (varegacestat) reduced risk of disease progression or death by 84% in...
Sanofi snaps up ADEL’s tau antibody: $1.04B licensing pact
Sanofi agreed to license ADEL’s tau‑targeting antibody ADEL‑Y01 in a deal worth up to $1.04 billion, including an $80 million up‑front payment, ADEL and Sanofi disclosed. The agreement grants...
Chai Discovery raises $130M — AI antibody design goes mainstream
Chai Discovery closed a $130 million Series B at a reported $1.3 billion valuation to expand its AI‑driven de novo antibody platform, the company announced. The round — led by Oak HC/FT and...
Radiopharm’s RAD‑101 PET tracer hits imaging endpoints in brain mets trial
Radiopharm Theranostics reported interim Phase IIb imaging results showing RAD‑101 (F18‑Pivalate) met its primary endpoint, achieving concordance with MRI in 92% of treated brain metastasis...
Droplet validates postoperative lymph fluid for MRD detection in head and neck cancer
Droplet Biosciences and academic collaborators published validation data showing postoperative lymph fluid can detect circulating tumor DNA (ctDNA) with higher sensitivity than matched early...
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...