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Roche’s BTK Pill Clears Another Phase 3 — Safety Signal Complicates Approval Path
Roche reported a third positive Phase 3 trial for fenebrutinib in multiple sclerosis, meeting primary endpoints, but the studies revealed a concerning liver safety signal and an imbalance in...
Nanopore Momentum: Oxford Posts Revenue Gain as CHOP, Seattle Children’s Adopt Rapid Sequencing
Oxford Nanopore announced 22% full‑year 2025 revenue growth after a strategic restructuring that narrowed product focus and reduced some R&D headcount. The company said it is prioritizing...
Evinova Signs AI Pacts With Big Pharma to Benchmark and Speed Clinical Trials
Evinova, an AstraZeneca‑established AI‑native clinical development platform, signed agreements allowing Astellas, Bristol Myers Squibb and AstraZeneca to use its systems for study design...
Earendil Licenses WuXi Payload‑Linker Tech in Up‑to‑$885M ADC Deal
Earendil Labs signed a global license and development pact with WuXi XDC worth up to $885 million to use WuXi’s payload‑linker technology and CRDMO capabilities for antibody‑drug conjugate (ADC)...
FDA Accelerates Approval of Ascendis’ Yuviwel – New Challenger in Achondroplasia
The U.S. Food and Drug Administration granted accelerated approval to Ascendis Pharma’s TransCon CNP (now Yuviwel/navepegritide) for children two and older with achondroplasia, based on gains in...
Plasma mcfDNA Sequencing Predicts Bloodstream Infections Days Earlier in Pediatric Leukemia
Researchers at St. Jude Children’s Research Hospital published a Lancet Microbe study showing that plasma microbial cell‑free DNA sequencing (mcfDNA‑Seq) can detect bloodstream infections in...
UniQure blocked by FDA: sham‑surgery trial requested
The FDA has told uniQure that its current data package for AMT‑130, a gene therapy for Huntington’s disease, is not sufficient and recommended a prospective, randomized, double‑blind, sham...
FDA lifts hold on Intellia CRISPR trial – Magnitude restarts with caveats
The FDA has fully released a clinical hold on Intellia’s Phase 3 Magnitude trial testing its CRISPR base‑editing therapy nexiguran ziclumeran (nex‑z) for transthyretin amyloidosis with...
Ascendis wins accelerated FDA OK – weekly achondroplasia shot cleared
The FDA granted accelerated approval to Ascendis Pharma’s once‑weekly TransCon CNP (now branded Yuviwel; navepegritide) for children aged two and older with achondroplasia. The clearance, based on...
Aardvark pauses Phase III HERO trial after cardiac signals – shares tumble
Aardvark Therapeutics halted dosing and enrollment in its Phase 3 HERO trial testing ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring detected reversible cardiac...
Roche’s BTK pill clears a Phase 3 but safety questions mount
Roche reported a third positive Phase 3 for fenebrutinib in multiple sclerosis, positioning the BTK inhibitor for regulatory submissions. The drug hit its primary efficacy endpoints across...
Candid to go public via reverse merger with Rallybio — $505M raised
Candid Therapeutics agreed to merge with Rallybio in a reverse merger that will take the T‑cell engager specialist public on Nasdaq under the CDRX ticker, and secured approximately $505 million in...
Evinova inks enterprise AI deals with AstraZeneca, BMS and Astellas
Evinova, an AstraZeneca‑launched AI‑native clinical development unit, signed deals with Astellas, Bristol Myers Squibb and parent AstraZeneca to deploy its AI platform for study design...
Earendil licenses WuXi XDC payload‑linker tech in up‑to‑$885M ADC deal
AI‑driven antibody developer Earendil Labs licensed payload‑linker technology from WuXi XDC in a partnership with potential value up to approximately $885 million, including upfronts, development...
Oxford Nanopore trims portfolio after restructuring as revenue rises 22%
Oxford Nanopore reported 2025 revenue of £223.9 million, a 22% year‑over‑year increase, and detailed a strategic restructuring that included job reductions and a narrower product focus. The...
United Therapeutics preps FDA filing after Phase 3 ralinepag win in PAH
United Therapeutics reported a positive Phase 3 trial for ralinepag in pulmonary arterial hypertension, tying the drug to a 55% reduction in risk of clinical worsening. The company plans to file...
FDA grants Ascendis accelerated approval – Yuviwel cleared for achondroplasia
The U.S. Food and Drug Administration granted accelerated approval to Ascendis Pharma’s once‑weekly TransCon CNP (now Yuviwel) for children aged two and older with achondroplasia. The decision was...
FDA urges randomized sham‑controlled trial for uniQure's AMT‑130 – shares tumble
UniQure disclosed that FDA staff strongly recommended a randomized, double‑blind, sham surgery‑controlled study for its Huntington’s disease gene therapy AMT‑130, saying existing...
Aardvark pauses Phase 3 HERO study after cardiac signals – enrollment halted
Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase 3 HERO trial of ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring in a healthy volunteer...
FDA lifts hold on Intellia’s Magnitude Phase 3 – safety guardrails imposed
The FDA lifted a clinical hold on Intellia Therapeutics’ Magnitude Phase 3 trial of nexiguran ziclumeran (nex‑z) for transthyretin amyloidosis with cardiomyopathy (ATTR‑CM), allowing enrollment to...