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In vivo CAR T deals heat up
Johnson & Johnson moved deeper into in vivo CAR-T by paying $785 million upfront to partner with Sail Biomedicines, with additional milestone payments tied to development goals. The agreement also...
FDA adcom swings on Replimune melanoma therapy
Replimune’s twice-rejected melanoma candidate RP-1 cleared an FDA advisory committee hurdle after panelists voted 10–3 that the Ignyte phase II efficacy results were evaluable and clinically...
Deramiocel DMD cell therapy rejected by FDA panel
An FDA advisory committee voted 9–3 against recommending approval of Capricor’s deramiocel for Duchenne muscular dystrophy cardiomyopathy, capping off a meeting marked by statistical disagreement...
Apnimed IPO funds FDA decision for Oxnimbi
Apnimed priced an upsized $192 million IPO to fund launch preparation for Oxnimbi (AD109), its oral obstructive sleep apnea therapy. The company boosted the offering to 12 million shares at...
Guardant oncology revenue growth and FDA companion diagnostic approval
Guardant Health reported Q2 revenue up 44% year over year to $335 million, led by a surge in oncology testing volume and expanding reimbursement momentum. Oncology revenue rose 38% as Guardant...
Tempus expands oncology diagnostics growth and MRD strategy
Tempus AI posted Q2 results driven by growth in its oncology testing business, pushing total revenue to $382.5 million and raising 2026 revenue guidance to $1.6–$1.61 billion. The company said the...
Latigo posts Phase 2b non-opioid pain win vs placebo
Latigo Biotherapeutics reported positive Phase 2b results for LTG-001, a non-opioid oral inhibitor of Nav1.8 designed to deliver opioid-level analgesia. In a Phase 2b trial after abdominoplasty,...
Relation and GSK expand cellular foundation model collaboration
Relation Therapeutics and GSK announced an expanded research collaboration to generate large-scale cellular perturbation datasets for cellular foundation models. Under the terms, Relation could...
Cleerly and Allelica launch coronary polygenic risk test
Cleerly and Allelica announced a partnership to launch the Cleerly Polygenic Cardiovascular Risk Score Test, using saliva-based genetics and Allelica’s multi-ancestry polygenic risk score to...
Genoria AI targets autonomous wet-lab research
MGI Tech launched Genoria AI, a new AI subsidiary tasked with developing and commercializing autonomous lab tools that can plan and execute experiments. The company described Genoria’s goal as...
FDA advisory panel pushes back on advanced melanoma gene therapy
Replimune’s RP-1 for unresectable metastatic cutaneous melanoma cleared an FDA Cellular, Tissue, and Gene Therapies Advisory Committee hurdle, after the panel voted 10-3 that the Ignyte phase II...
FDA panel splits over Capricor Duchenne cell therapy evidence
The FDA’s advisory committee delivered a contentious verdict on Capricor Therapeutics’ deramiocel for Duchenne muscular dystrophy, voting 9-3 against recommending approval. Panelists said the...
Cell therapy milestone: deramiocel phase 3 trial shows slowing muscle decline
A phase 3 study published in The Lancet reports that deramiocel could slow muscle weakening in boys and young men with advanced Duchenne muscular dystrophy, where there is no cure. In HOPE-3,...
In vivo CAR T deal accelerates J&J push into immune reset
Johnson & Johnson struck an in vivo CAR T collaboration with Sail Biomedicines, paying $785 million upfront for the right to pursue Sail’s autoimmune programs and option to acquire the company....
Revenue momentum: Guardant Health credits oncology and FDA companion diagnostic approval
Guardant Health reported a 44% year-over-year rise in Q2 revenue, driven by oncology testing growth and expanding coverage for its Shield blood screening assay. The company also pointed to the...
Diagnostics scale-up: Tempus lifts guidance on oncology test growth and MRD acquisition plans
Tempus AI reported stronger-than-expected Q2 results, citing a 31% year-over-year increase in its oncology testing business and raising full-year 2026 revenue guidance to between $1.6 billion and...
Advisory panel clears: gene therapy evidence dispute shifts back toward approval calculus
Replimune’s RP-1 resubmission overcame skepticism after FDA advisers voted it “evaluable and clinically meaningful,” putting the therapy back on track after repeated setbacks. The panel’s decision...
Biotech funding and market appetite: Apnimed upsized IPO for sleep apnea pill
Apnimed priced an upsized $192 million IPO to fund its obstructive sleep apnea therapy Oxnimbi (AD109), as the program moves toward an FDA decision expected by February 2027. The company increased...
Function Health banks large growth financing for preventive testing expansion
Function Health raised $450 million in growth financing from General Catalyst’s Customer Value Fund, following its $298 million Series B just eight months earlier. The lab-testing startup said it...
AI foundation models: Relation and GSK sign multiomic perturbation pact
Relation Therapeutics secured a collaboration with GSK to generate large-scale cellular perturbation data for cellular foundation models, with potential payments up to $110 million. The deal...