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Immunology delivery and anticancer immunity via microbiome-derived signals
Sungkyunkwan University and the University of Michigan reported an oral microbiome nanomedicine designed to boost anticancer immunity, using a small molecule produced by gut bacteria to prime the...
Regulatory and reimbursement: 340B payment and rebate model shifts
HHS’s 340B program rules moved again as CMS and HRSA advanced complementary changes aimed at reshaping how covered entities are paid and how manufacturers supply ceiling-price rebates. CMS...
Late-stage pipeline setbacks and capital preservation after clinical failures
Sionna Therapeutics disclosed that its cystic fibrosis add-on strategy failed in a Phase 2 trial, after the company tested the NBD1 stabilizer SION-719 in combination with Vertex’s Trikafta. The...
Clinical expansion in rare disease: Series B funding for Vaderis hereditary hemorrhagic telangiectasia (HHT)
Vaderis Therapeutics raised an oversubscribed $152 million Series B to push engasertib (VAD-044) into Phase 3 for hereditary hemorrhagic telangiectasia (HHT). The financing was co-led by Life...
FDA approvals: first-of-its-kind therapies and precision diagnostics
The FDA approved Takeda’s Orzeyful (oveporexton), described as the first therapy designed to address the underlying cause of narcolepsy type 1 in adults. The approval follows clearance from...
Immunotherapy durability in inflammatory disease: AbCellera hot-flash Phase 2 and downstream Phase 3 benchmark-setting
AbCellera reported positive top-line Phase 2 results for ABCL635, an investigational NK3R antagonist antibody being developed for moderate-to-severe vasomotor symptoms (hot flashes) due to...
Biologics financing and clinical entry for eczema competitors to Dupixent
Infinimmune secured $75 million in Series A funding to develop antibody candidates for atopic dermatitis, targeting IL-22 with IFX-101 and IL-13 with IFX-201. The financing was positioned as fuel...
Platform funding: Remedium Bio launches durable protein therapeutics Series A
Remedium Bio announced the initial closing of a planned $10 million Series A as it advances its durable protein therapeutics platform toward first-in-human studies. The funding is earmarked for...
Oncology immunotherapy resistance biology: myeloid networks and tumor immune failure
A study in Science Bulletin reported how macrophages contribute to resistance to immune checkpoint blockade in gastric cancer, identifying immune checkpoint therapy as effective only for subsets...
Disease mechanism and translational acceleration: FDA-enabled gene editing trial risk watch and cell therapy pipeline moves
Ribox Therapeutics obtained FDA IND clearance for RXIM-002, a circular RNA (circRNA)-based in vivo CAR-T approach delivered by a targeted lipid nanoparticle. The company will initiate a Phase I...
Atopic dermatitis antibody race heats up
Infinimmune secured $75 million in Series A funding to advance two lead antibody programs targeting atopic dermatitis into the clinic starting in 2027. The Bay Area immunology startup is...
Rare bleeding disorder bankrolls Phase 3 push
Vaderis Therapeutics closed an oversubscribed $152 million Series B to advance engasertib (VAD-044) for hereditary hemorrhagic telangiectasia (HHT). The financing is designed to fund the Phase 3...
CRISPR gene-edited therapy safety spotlight
A reported gene-editing death in China adds to scrutiny around the clinical safety of investigational genome editing approaches. Two weeks after the disclosure of a gene editing death involving a...
FDA blocks radiopharma competitor to Lutathera
The FDA issued a complete response letter for ITM Isotope Technologies Munich SE’s radiotherapeutic ITM-11 (177Lu-edotreotide) targeting gastroenteropancreatic neuroendocrine tumors, citing...
Antibody engineering startup opens clinic data run for hot flashes
AbCellera reported positive topline Phase 2 results for ABCL-635, an injectable neurokinin 3 receptor (NK3R) antagonist antibody for menopausal vasomotor symptoms. In a randomized, double-blind,...
China clearance for FGFR2+ cholangiocarcinoma after FGFR therapy
Transthera Sciences received NMPA approval in China for Yochanra (tinengotinib), a treatment for FGFR2-positive cholangiocarcinoma that has progressed after prior FGFR inhibitor therapy. The...
Discovery platform funding: durable protein therapeutics
Remedium Bio raised an initial $10 million Series A financing to push its durable protein therapeutics platform toward first-in-human development. The company is framing the round as early runway...
Heart regeneration funding lands for USC stem-cell trial
The Marcus Foundation awarded $28.7 million to Chuck Murry, MD, PhD, director of the USC Stem Cell Center, to support a clinical trial testing a stem cell-based therapy to regenerate heart muscle...
Venture-backed gene editing competitor eyes hearing restoration
STAT+ reported that Skylark Bio dosed its first patient in a gene therapy trial targeting hearing loss associated with GJB2 mutations. The move follows renewed attention on gene therapy in...
Large insurer panel calls out AI adoption limits
A new analysis points to a performance gap in AI claims from large U.S. health insurers, arguing that operational reality is slowing adoption. The reporting describes how insurers including...