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Pipeline derisking in multiple myeloma cell therapy
Bristol Myers Squibb secured a pivotal clinical win for its BCMA-directed CAR T arlocabtagene autoleucel after reporting Phase 2 results in heavily pretreated relapsed/refractory multiple myeloma....
Clinical holds and trial interruptions in epilepsy drug development
The FDA placed Biohaven’s ion channel program BHV-7000 on partial clinical hold, Biohaven disclosed. An epilepsy study was paused after regulators requested additional information about...
Oncology trial updates and dose strategy shifts in bladder cancer
Tyra Biosciences reported early Phase 2 results for oral dabogratinib (FGFR3-altered, low-grade, intermediate-risk non-muscle-invasive bladder cancer) and moved to define a go-forward dose of 60...
Immunology: MMP-9 antibody approach targets diabetic peripheral neuropathy
Researchers at UTHealth Houston reported preclinical results in Science Translational Medicine showing that monoclonal antibodies inhibiting matrix metalloproteinase-9 (MMP-9) can slow and even...
Gene therapy readiness for Huntington’s readout
UniQure is expected to report four-year results before the end of September for AMT-130, its gene therapy for Huntington’s disease, according to a STAT+ preview. The trial has already reported...
Funding: Encrypted series F for Dravet genetics program
Encoded Therapeutics closed a $275 million Series F round to advance its Dravet syndrome genetic medicine program and scale internal manufacturing. The round was led by GV and included an...
Biotech dealmaking and asset acceleration in protein engineering and diagnostics
Roche moved to fill a preclinical gap in B-cell disease by signing a potential $1.53 billion license deal for SIM-0600 from Simcere Zaiming Pharmaceutical. The trispecific antibody-sized TCE is...
China regulatory approvals: first-time clinic clearances for new modalities
China’s NMPA cleared multiple differentiated therapies and early-stage candidates for clinical use, including CSPC’s SYH-2083 for dry eye disease and Innocare’s ADC ICP-B381 for solid tumors such...
Obesity and diabetes expansion via new startups and spinouts
Kura Oncology spun out Caspian Therapeutics to advance menin inhibitors into diabetes and other cardiometabolic indications, backed by Eli Lilly and led with $50 million in Series A funding. The...
FDA stability and leadership continuity
The U.S. FDA moved to stabilize its drug and biologics leadership, promoting Michael Davis to director of CDER and Karim Mikhail to director of CBER in permanent roles. The shift follows a period...
Regulatory access and courtroom scrutiny over patient assistance
A U.S. appeals court signaled limits on HHS regulatory discretion, siding with Vertex in part while agreeing an HHS advisory opinion was issued too late. The decision raised compliance stakes for...
FDA approval for next-generation SERD in breast cancer
AstraZeneca’s camizestrant (Etcamah) cleared a major regulatory hurdle in the U.S., receiving accelerated approval for certain patients with HR+/HER2- advanced breast cancer with ESR1 mutations...
Biotech funding: drug platform moves to clinic with major Series B
Moonwalk Biosciences closed a $70 million Series B to advance MW-101, an adipose-targeted RNAi obesity candidate, into human testing. The company plans late-2027 first-in-human studies after...
Genetic medicine: Encoded books additional capital for Dravet program and manufacturing
Encoded Therapeutics raised $275 million in a Series F round to support its Dravet syndrome drug and expand internal manufacturing. The financing, led by GV with a second undisclosed healthcare...
Cancer cell therapy: Amgen’s BCMA-era strategy expands in lung cancer
Amgen reported a key lung cancer win for its T-cell engager strategy, pairing Imdelltra (tarlatamab) with AstraZeneca’s Imfinzi (durvalumab) to improve outcomes in advanced lung cancer. The...
Myeloma immunotherapy case report: CNS remission with intrathecal pairing
Physicians in Türkiye reported a case where a heavily pre-treated multiple myeloma patient achieved complete, durable remission of CNS involvement after receiving a BCMA-targeted bispecific...
Biotech financing: UK/Europe and immunology waves into late-stage readiness
Solstice Oncology secured $225 million in Series A financing to advance a next-generation CTLA-4 immunotherapy (from Harbour BioMed) into clinical development. The funding aims to support...
Oncology clinical readouts: BMS CAR T positioned for harder-to-treat myeloma
Bristol Myers Squibb scored a development milestone for arlocabtagene autoleucel after results in a Phase 2 study met endpoints that analysts view as a “derisking event.” The QUINTESSENTIAL trial...
IND/clinical expansion in autoimmune and oncology
Pharvaris reported positive phase III prevention data for hereditary angioedema attacks with deucrictibant, complementing earlier findings in acute treatment. Separately, surrogates of Wnt/VEGF...
FDA leadership stability
The FDA moved to lock in continuity for drug and biologics regulation by naming Michael Davis permanent director of CDER and Karim Mikhail permanent director of CBER. Acting designations were...