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FDA advisory pushes oncology cell therapy forward
Replimune’s RP-1 (suvolimogene oderparepvec) moved one step closer to a potential FDA decision after an advisory committee vote endorsed the company’s efficacy readouts for unresectable metastatic...
Novo Nordisk’s IL-6 heart inflammation bet stumbles in Phase 3
Novo Nordisk took another hit as its Phase 3 cardiovascular outcomes program for ziltivekimab failed to reduce major adverse cardiovascular events versus placebo. The Zeus trial enrolled more than...
Biotech earnings shakeouts deepen amid guidance cuts
Alnylam’s stock tumbled after management trimmed its full-year forecast for ATTR franchise revenues, citing normalization of early launch dynamics. Following disappointing Amvuttra sales and...
Public-market cash raises for drug development
Apnimed secured an upsized $192 million IPO to fund launch preparations for Oxnimbi (AD109), its sleep apnea pill aimed at reducing nightly breathing disruptions. The company priced 12 million...
M&A scales up surgical and device footprint
Mimedx agreed to buy Sanara Medtech in a cash-and-stock transaction valuing the deal at approximately $350 million as it looks to move beyond its wound-care business. The company’s wound segment...
In vivo CAR T expands with major J&J pact
Johnson & Johnson entered a new chapter in in vivo CAR T after signing a collaboration with Sail Biomedicines that includes a $785 million upfront payment and an option to acquire the company for...
Gene-editing ethics under pressure after fatal trial
A death in a China-based, brain-directed gene-editing trial is rekindling questions about oversight for first-in-human personalized therapies. Reporting describes the case of a 6-year-old girl...
CAR-T-like immune reset takes shape via next-generation in vivo partnerships
Johnson & Johnson and Sail Biomedicines extended momentum in the in vivo CAR T race through a structured collaboration built around Sail’s delivery and expression engineering. The agreement, which...
AI valuation and foundation-model momentum stays under scrutiny
Investors continue to probe whether AI investment meaningfully changes biotech valuation, according to a new market read on healthcare AI narratives. A review by Fishbone Advisors argues that the...
Personalized diagnostics grow as oncology testing drives revenue
Guardant Health reported strong growth as oncology testing revenue rose sharply in the second quarter, boosting overall results. Oncology revenue climbed 38% year over year to $219.1 million,...
Cell therapy dealmaking in vivo CAR T
Johnson & Johnson moved deeper into in vivo CAR T by paying $785 million to partner with Sail Biomedicines, including a $465 million equity investment and milestone payments. The agreement also...
FDA advisory vote swing for Replimune melanoma therapy
Replimune’s RP1 won support from an FDA advisory committee, with panelists voting 10-3 that the efficacy data are evaluable and clinically meaningful. The recommendation increases the odds the FDA...
Phase 3 setbacks and cash pressure in oncology
Karyopharm’s shares cratered after Xpovio (selinexor) failed again to meet the progression-free survival primary endpoint in a Phase 3 endometrial cancer study. The readout, reported as...
Novo Nordisk IL-6 heart failure highlights cardiovascular inflammation risk
Novo Nordisk’s Phase 3 cardiovascular outcomes trial Zeus failed after its IL-6 inhibitor ziltivekimab did not reduce major adverse cardiovascular events versus placebo. Novo reported an HR of...
Alnylam ATTR franchise: guidance cut triggers investor shock
Alnylam’s stock dropped sharply after the company lowered sales guidance for Amvuttra and adjusted outlook for its transthyretin amyloidosis franchise. In reporting, Alnylam said Amvuttra’s...
In vivo immunotherapy funding: Brenus Series A extension
Brenus Pharma secured an €11 million Series A extension (about $12.6 million) and brought in its first APAC investor as international interest grows in its in vivo immunotherapy platform. The...
Diagnostics and clinical adoption: Tempus oncology testing growth and Personalis deal
Tempus AI reported a second-quarter revenue boost driven by strong oncology testing demand, citing continued momentum from FDA approvals. The company raised full-year 2026 revenue guidance to $1.6...
Radiopharma and late-stage capital formation
Ratio Therapeutics raised $70 million to advance radiopharmaceutical trial development, funding continued work in its radiopharma pipeline. The Series C was described as coming from existing...
AI-guided drug discovery platform deals: Relation and GSK
Relation Therapeutics struck a collaboration with GSK to generate large-scale cellular perturbation datasets for use in cellular foundation models. Relation may receive up to $110 million in...
Cancer diagnostics testing growth and guideline-linked coverage
Guardant Health posted a second-quarter revenue gain driven by oncology testing growth, including a sharp rise in colorectal cancer screening volume. The company reported total Q2 revenue of $335...