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Personalized cancer mRNA therapy
Merck and Moderna reported a pivotal Phase 3 readout in melanoma for their personalized neoantigen mRNA regimen (Keytruda plus intismeran autogene), meeting the trial’s primary endpoint at interim...
FDA approvals – gene therapy and bone disease antibody
The FDA cleared Ultragenyx’ one-time AAV8 gene therapy Genglycos (pariglasgene brecaparvovec; DTX-401) for glycogen storage disease type Ia (GSDIa) in patients 8 years and older, marking the first...
FDA clearance – rare blood cancer siRNA
Silence Therapeutics advanced its rare blood cancer siRNA program after announcing positive Phase II results for divesiran in polycythemia vera (PV). In the SANRECO trial (NCT05499013), Silence...
M&A and reverse mergers – market access moves
Ambros Therapeutics agreed to merge with Werewolf Therapeutics in an all-stock deal after Werewolf’s search for strategic alternatives, while raising $150 million to support a Phase 3 path for its...
Clinical strategy – first-line EGFR exon 20 targeted therapy
In a Phase 3 trial published at NEJM.org, Dizal Pharmaceuticals’ sunvozertinib outperformed chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertions. The randomized...
New factory and trial timing – manufacturing and program signals
Genentech is investing $750 million in a new drug delivery device facility at its Hillsboro, Oregon site, aimed at expanding manufacturing capacity for delivery technologies. In parallel, Bavarian...
Biotech funding – late-stage clinical push in inclusion body myositis
Abcuro raised $66 million in a Series D to advance ulviprubart, an investigational monoclonal antibody for inclusion body myositis. The company said the round supports a registrational clinical...
AI in diagnostics and health systems – trust, reliability, and foundations
Deepcell and Gilead are co-developing an AI foundation model for CHO cell line development, training on Deepcell’s REM-I single-cell morphology data using self-supervised learning and planning an...
Targeted delivery for gene editing in vivo
A Nature Biomedical Engineering study described a non-viral strategy to edit human blood stem cells inside the body using targeted lipid nanoparticles. Published by Zhiwei Luo, A.T. Zhu, and...
Hematology transplant access – broader donor selection
The multicenter ACCESS clinical trial suggests expanded options for blood cancer patients who struggle to find closely matched stem cell donors. The study reported that carefully selected younger...
FDA approvals – gene therapy for ultra-rare glycogen storage disease
The FDA cleared Ultragenyx’s one-time gene therapy Genglycos (pariglasgene brecaparvovec; DTX-401) for glycogen storage disease type Ia (GSDIa), marking both an accelerated approval and...
FDA approvals – bone disorder antibody moves into clinic competition
The FDA approved Regeneron’s activin A–targeting antibody, garetosmab—branded Pasatru—for fibrodysplasia ossificans progressiva (FOP), giving patients a second approved option in the ultrarare...
Phase 3 oncology – personalized mRNA neoantigen vaccine shows recurrence benefit in melanoma
Merck and Moderna reported positive results from a randomized Phase 3 study of their personalized mRNA neoantigen vaccine, intismeran autogene, in combination with Keytruda for resected high-risk...
Phase 2 rare blood cancer – siRNA therapy delivers large hematocrit response vs placebo
Silence Therapeutics advanced its small interfering RNA (siRNA) program for polycythemia vera (PV), reporting positive Phase 2 results for divesiran in the SANRECO trial (NCT05499013). The company...
M&A reshapes industry teams – workforce cuts follow integrated deals
Layoffs are continuing to follow biopharma mergers, with workforce cuts tied to recent transactions projected to total more than 1,300 job losses across multiple companies. The report highlights...
Clinical trial update – Sunvozertinib extends progression-free survival in EGFR exon 20 NSCLC
Dizal Pharmaceuticals’ sunvozertinib outperformed chemotherapy in a Phase 3 first-line trial in advanced NSCLC with EGFR exon 20 insertion mutations, according to results published in NEJM. In the...
Trial and access – stem cell donor options broaden using mismatched donors
The multicenter ACCESS trial reported data suggesting that blood cancer patients without closely matched stem cell donors may still benefit from carefully selected younger donors with substantial...
Diagnostics and reimbursement – NGS adoption lags despite Medicare national coverage
An analysis of U.S. Medicare claims data found that next-generation sequencing (NGS) uptake in cancer increased after Medicare began covering testing in 2018, but persistent access gaps remain for...
Biotech growth capital – Abcuro raises Series D to advance inclusion body myositis candidate
Abcuro raised $66 million in a Series D financing to fund a registrational clinical study of ulviprubart for inclusion body myositis (IBM). The Newton, Massachusetts-based clinical-stage biotech...
Enterprise AI in drugmaking – Deepcell and Gilead collaborate on CHO cell morphology foundation model
Deepcell and Gilead Sciences launched a co-development effort to build an AI foundation model for Chinese hamster ovary (CHO) cell line development using cell morphology. The partnership will...