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Nanopore moment: Oxford Nanopore posts 22% revenue growth as clinics adopt rapid sequencing
Oxford Nanopore reported 22% revenue growth for 2025 while announcing strategic restructuring that narrowed product lines and reduced R&D headcount. The company will discontinue lower‑priority...
Candid to go public via reverse merger with Rallybio – $505M raised
Candid Therapeutics struck a reverse merger with Rallybio and secured roughly $505 million in private financing to support advancement of its T‑cell engager pipeline. The combined company will...
Earendil inks up to $885M ADC pact with WuXi XDC – expands ADC and T‑cell engager programs
AI‑driven biologics firm Earendil Labs licensed WuXi XDC’s payload‑linker ADC technology in a deal potentially worth up to $885 million, granting Earendil a global license and access to WuXi XDC’s...
Roche’s fenebrutinib posts pivotal Phase 3 wins – safety signals prompt scrutiny
Roche reported additional Phase 3 successes for fenebrutinib across multiple sclerosis indications, positioning the BTK inhibitor for regulatory submissions. However, trials flagged liver‑related...
United Therapeutics posts Phase 3 win in PAH – ralinepag filing planned
United Therapeutics reported Phase 3 results showing ralinepag reduced the risk of clinical worsening by about 55% in pulmonary arterial hypertension, setting the company up to seek FDA approval...
Regulators clear AI and software tools — FDA De Novo, EU IVDR Class C signposts
Two regulatory milestones arrived for clinical software this week: the FDA granted De Novo clearance to Ultrasound AI’s cloud‑based Delivery Date AI that predicts delivery date from standard...
United Therapeutics to seek FDA: ralinepag halves risk of PAH clinical worsening
United Therapeutics reported a positive Phase 3 outcome for ralinepag and said it will pursue an FDA filing this year. The company linked the once-daily candidate to a substantial reduction in...
FDA lifts holds – Intellia clears path to resume Phase 3 CRISPR trials
The FDA lifted a clinical hold and allowed Intellia to resume one of two Phase 3 trials testing its CRISPR-based therapy nexiguran ziclumeran (nex-z) for transthyretin amyloidosis (ATTR). The...
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...