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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...
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...