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Clinical setbacks and competitive pressure in oncology
Novartis disclosed two separate Phase III failures that further stress its late-stage pipeline. The company said delpacibart etedesiran failed to meet the primary endpoint in the HARBOR trial for...
Breast cancer regulatory win for a next-gen SERD
AstraZeneca won an FDA accelerated approval for camizestrant, trading under the Etcamah brand, after an advisory committee previously voted against the drug’s first-line breast cancer use. The...
CAR-T efficacy signal in relapsed/refractory myeloma
Bristol Myers Squibb reported Phase 2 success for an engineered GPRC5D-directed CAR-T program, highlighting a potential new option for patients after relapse when standard approaches fall short....
RNAi and obesity funding rounds
Moonwalk Biosciences raised $70 million in a Series B to move MW101, an adipose-targeted RNAi obesity candidate, toward first-in-human trials planned for late 2027. The funding supports...
Diabetes biotech spinout from Kura oncology
Kura Oncology spun out Caspian Therapeutics to develop menin inhibitors for diabetes and other cardiometabolic diseases. Caspian launched with $50 million in Series A funding led by BVF Partners...
New capital for genetic medicine in rare disease
Encoded Therapeutics closed a $275 million Series F round to advance its Dravet syndrome genetic medicine program and to scale its internal manufacturing capabilities. The precision genetic...
ARPA-H funding for heart disease AI tools
ARPA-H launched a program called ADVOCATE to build FDA-authorized agentic AI tools for care in heart disease. UpDoc, Tempus AI, and Atman Health were selected to participate, with the government...
Immuno-oncology funding for a next-gen CTLA-4 strategy
Solstice Oncology raised $225 million in Series A funding to advance a next-generation CTLA-4 immunotherapy originating from Harbour BioMed. The company said it aims to move the asset into Phase...
Diabetes drug development via NMPA approvals in China
China’s NMPA approved two differentiated therapies: Cardamyst, a self-administered nasal spray for paroxysmal supraventricular tachycardia from Everest Medicines, and Yingmule, a long-acting RSV...
FDA leadership stability signals continuity for regulators and sponsors
The FDA moved to permanent leadership in two critical drug and biologics centers, naming Michael Davis as director of CDER and Karim Mikhail as director of CBER after a period of acting...
Encoded and partners raise to scale genetic medicine manufacturing for Dravet
Encoded Therapeutics closed a $275 million Series F round led by GV and an undisclosed healthcare investor, funding its Dravet syndrome program and efforts to scale internal genetic-medicine...
ARPA-H expands heart-disease AI tooling with industry and real-world partners
ARPA-H selected UpDoc, Tempus AI, and Atman Health for ADVOCATE, a federal program aimed at building FDA-authorized agentic AI tools to manage heart disease. The initiative reflects the agency’s...
CAR-T front: BMS narrows relapsed multiple myeloma risk with QUINTESSENTIAL outcome
Bristol Myers Squibb’s GPRC5D-directed CAR-T, Imdelltra (tarlatamab), paired with AstraZeneca’s Imfinzi (durvalumab), met its primary overall survival endpoint in a phase III trial for first-line...
Pharvaris prepares for HAE FDA decision after second phase 3 success
Pharvaris added positive phase III clinical data showing its oral bradykinin B2 receptor agonist deucrictibant is effective in preventing hereditary angioedema (HAE) attacks, building on earlier...
Tyra’s FGFR3 bladder cancer update disappoints on Phase 2 outcomes
Tyra Biosciences reported initial phase II data for dabogratinib in FGFR3-altered low-grade intermediate-risk non-muscle-invasive bladder cancer and set a go-forward dose of 60 mg once daily. The...
Novartis CAR T and Lp(a) setbacks add pressure after Avidity and pelacarsen failures
Novartis confirmed delpacibart etedesiran missed the primary endpoint in a phase III trial for myotonic dystrophy type 1, adding to a week of clinical setbacks across its portfolio. The company...
Moonwalk raises $70M Series B to push adipose-targeted RNAi obesity candidate into clinic
Moonwalk Biosciences closed a $70 million Series B financing to advance MW-101, its adipose-targeted siRNA obesity candidate, into clinical development. The company plans to use the funding for...
Gene therapy step forward in Sandhoff disease model with intravenous AAV
A study in Science Translational Medicine reports that intravenous AAV gene therapy extended lifespan and improved clinical outcomes in a feline model of Sandhoff disease. The therapy delivered...
Biotech manufacturing and quality: microscale chromatography shows manufacturing-aligned process signals
Researchers evaluated automated 600-µL RoboColumns against conventional ÄKTA bench-scale chromatography and manufacturing-scale operations for purification of a bispecific antibody, focusing on...
Capital raises for precision genetics in epilepsy
Encoded Therapeutics closed a $275 million Series F to advance its Dravet syndrome precision genetics program and scale its manufacturing footprint. The round was led by GV and included an...