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FDA greenlights gene therapy for Sanfilippo syndrome type A
The FDA has approved Ultragenyx’s gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A, marking the first FDA-approved disease-modifying treatment for the ultra-rare,...
BMS drops $100M Orum degrader-antibody conjugate after phase 1 readout
Bristol Myers Squibb has terminated development of a degrader-antibody conjugate it acquired from Orum Therapeutics for $100 million after reviewing phase 1 data. The decision, reported through an...
Electra Therapeutics launches after upsized inflammation IPO
Electra Therapeutics has raised $350 million in an upsized initial public offering after pricing its Nasdaq debut. The company positions itself as a commercial-stage inflammation biotech, using...
Regulatory oversight: FDA increases foreign clinical site inspection resources
The FDA announced it will expand resources for overseas bioresearch monitoring (BIMO) inspections and update risk-based criteria for selecting foreign clinical trial sites for audit. The move...
Clinical trials acceleration: FDA launches Expedited IND pilot
The FDA has launched an Expedited Investigational New Drug pilot program aimed at shortening time to first-in-human trials in the U.S. The initiative, described as part of Operation Trialblazer,...
Corporate dealmaking: Roche signs first partner for Dualitas’ bispecific screen
Roche has signed an agreement with Dualitas Therapeutics to use Dualitas’ Dualscreen bispecific discovery engine to screen more than 300,000 bispecific antibody combinations. The deal is...
Oral immunology/immunology tech: Molecular Devices and STEMCELL automate organoid workflows
Molecular Devices and STEMCELL Technologies have announced a validated automated workflow for human intestinal organoid culture on the Molecular Devices CellXpress.ai system. The collaboration...
Funding: Mithrl raises $20M to scale an agentic biomedical model for R&D
Mithrl has raised $20 million in a Series A round led by Obvious Ventures to expand deployment of its “biomedical world model” across biopharma R&D. The company says its platform helps teams move...
Biotech financing and pipeline: North Immunology reverse merger raises $180M for eczema drug to clinic
North Immunology is going public through a reverse merger with Aethlon Medical, raising $180 million to advance an inflammation and immunology bispecific antibody program. The lead indication is...
Gene therapy approval in ultra-rare neurodegeneration
The FDA approved Ultragenyx’s gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A (MPS IIIA), making it the first specifically approved treatment for the ultra-rare,...
Reverse-merger funding for next-generation inflammation drugs
North Immunology is taking the reverse-merger route to reach the public markets, combining with Aethlon Medical in a deal that would provide about $180 million for its long-acting inflammation and...
Big IPO momentum in biotech
Electra Therapeutics priced a $350 million Nasdaq IPO, joining a wave of large 2026 listings and signaling continued appetite for commercial-stage biotech funding. The proceeds are slated to...
FDA oversight focus: accelerate early U.S. trials and expand foreign site audits
The FDA launched two related moves aimed at shifting more early drug development into the U.S. and tightening inspection capacity abroad. First, it opened applications for an expedited...
Massive platform deal for bispecific antibody discovery
Roche signed up Dualitas Therapeutics to run a broad bispecific screening effort using Dualitas’ Dualscreen engine, with deal economics reaching up to $1 billion. Dualitas will screen more than...
Regenerative and inflammation drug development support via RA-MAT designation
Allogene’s evolving allogeneic CAR-T approach is advancing under a FDA Regenerative Medicine Advanced Therapy (RMAT) designation, after the company reported encouraging interim data as it enrolls...
Precision cell therapy manufacturing automation partnerships
Molecular Devices and STEMCELL Technologies announced a validated automated workflow for culturing human intestinal organoids using the CellXpress.ai automated cell culture system. The companies...
AI in biopharma: funding for biomedical world-model acceleration
Mithrl raised $20 million in a Series A funding round led by Obvious Ventures to expand deployment of its “biomedical world model” across biopharma R&D. The company said its...
Oncology product development: label expansion path for Roche T-cell engager
Roche said its T cell engager Lunsumio cleared a Phase 3 confirmatory trial in a slow-growing blood cancer, clearing the path for full approval and a broader label. The company’s bispecific...
Molecular tool breakthrough: prime assembly enables targeted large DNA integration
Researchers described “prime assembly,” a genome engineering method published in Nature that enables targeted integration of long DNA fragments into precise programmable genomic locations. Built...
Gene therapy approval for Sanfilippo syndrome type A
The FDA approved Ultragenyx’s gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A, making it the first FDA-approved treatment specifically for the ultra-rare, fatal...