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Aardvark halts Phase 3 after cardiac signals – shares tumble
Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase 3 HERO trial of ARD‑101 for Prader‑Willi syndrome after routine safety monitoring in a healthy‑volunteer study revealed...
Roche nails another Phase 3 in MS – liver signal and deaths prompt scrutiny
Roche reported a third Phase 3 success for its BTK inhibitor fenebrutinib in multiple sclerosis, advancing plans for regulatory filings. The trial hit its primary efficacy endpoint, but...
FDA prefers randomized trial: UniQure’s AMT‑130 pathway stalls, stock plunges
The FDA told uniQure it does not view the existing single‑arm data package for AMT‑130, a gene therapy candidate for Huntington’s disease, as sufficient for approval and strongly recommended a...
Earendil taps WuXi XDC in up‑to‑$885M ADC pact
AI‑driven discovery firm Earendil Labs granted WuXi XDC a global license to its payload‑linker technology to develop antibody‑drug conjugates (ADCs) against multiple targets, creating an agreement...
Oxford Nanopore grows revenue 22% — restructures and trims R&D
Oxford Nanopore reported a 22% increase in 2025 revenue while disclosing a strategic restructuring that included job reductions and a narrower product focus. The company said it cut costs, ended...
Merck winds down Gardasil output in Durham — more than 150 jobs cut
Merck filed a WARN notice announcing it will end Gardasil and Gardasil 9 production at its Durham vaccine plant, laying off 147 employees at the Old Oxford Road site plus seven others. The...
BioAtla lays off 70% and launches strategic review of antibody portfolio
BioAtla announced a reduction of roughly 70% of its workforce as the antibody-focused biotech conducts a strategic review to explore potential sales, licensing or other transactions to maximize...
Atrium launches with $270M... takes RNA cardio assets from Novartis deal
Atrium Therapeutics began operations with a $270 million cash position after assuming Avidity Biosciences’ RNA technology and certain cardiology assets following Novartis’ acquisition. The company...
FDA presses uniQure: randomized sham‑control preferred for AMT‑130
The FDA told uniQure regulators are not persuaded that data from the completed single‑arm AMT‑130 trial are sufficient for approval and strongly recommended a prospective, randomized,...
Aardvark halts phase 3 HERO study after cardiac signals in volunteers
Aardvark Therapeutics paused its phase 3 HERO study of ARD‑101 following routine safety monitoring that identified reversible cardiac observations in a healthy volunteer study at doses above...
Roche’s fenebrutinib clears phase 3 endpoint — mortality signal clouds outlook
Roche reported a second phase 3 success for fenebrutinib in relapsing multiple sclerosis, with the trial hitting its primary endpoint and strengthening the company’s regulatory case for the BTK...
Belzutifan plus Keytruda extends disease‑free survival in high‑risk kidney cancer
The phase 3 LITESPARK‑022 trial showed that combining belzutifan, a HIF‑2α inhibitor, with pembrolizumab significantly improved disease‑free survival versus control in patients with high‑risk...
Atrium launches with $270M to pursue RNA therapies for rare cardiac disorders
Atrium Therapeutics emerged from Avidity Biosciences with a $270 million launch financing to pursue two RNA therapy programs targeting rare inherited cardiomyopathies. The spin‑out follows...
Chinese obesity biotech QL Biopharm secures $72M Series C with OrbiMed backing
QL Biopharm closed a roughly $72 million (500 million CNY) Series C financing led by OrbiMed and Qiming Venture Partners to advance late‑stage programs in obesity. The capital infusion will...
Bavarian Nordic CEO Paul Chaplin resigns after failed $3B takeover bid
Paul Chaplin, who led Bavarian Nordic for more than 30 years, announced his departure months after a proposed $3 billion takeover by private equity collapsed last November. The management change...
Novartis tests Rhapsido beyond hives — phase 2 food‑allergy readout posted
Novartis presented phase 2 data indicating its recently approved urticaria drug Rhapsido produced higher response rates in a food allergy cohort across three dose levels. The company framed the...
CAR macrophages breach brain barriers in preclinical lung‑metastasis models
Wake Forest University researchers engineered CAR macrophages (CARMA) that demonstrated brain‑penetrant immunotherapy activity against lung‑cancer brain metastases in preclinical studies. The...
AI pathology under fire: models learn shortcuts instead of biology
A University of Warwick study published in Nature Biomedical Engineering found that AI tools for cancer pathology are prone to “shortcut learning,” where models rely on spurious correlations in...
Close open steps: cell therapy manufacturers race to cut contamination risk
Manufacturers and regulators are pressing to eliminate open manipulations in cell therapy production to reduce contamination risk and scale operations. The article outlines how “open”...
Spain unveils end-to-end spatial‑omics platform: IRB Barcelona ties cores
IRB Barcelona has launched the country’s first end‑to‑end spatial‑omics workflow, uniting core facilities to support academic, clinical and industry users with tissue processing, multiplexed...