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FDA greenlights first dual BAFF/APRIL inhibitor for IgA nephropathy
The U.S. FDA granted accelerated approval to Vera Therapeutics’ Trutakna (atacicept) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. The...
Vertex to buy Crinetics in $10B push beyond cystic fibrosis
Vertex Pharmaceuticals agreed to acquire Crinetics Pharmaceuticals in a roughly $10 billion cash deal, expanding Vertex’s “fifth pillar” into endocrine diseases. The acquisition brings Crinetics’...
AstraZeneca and Ionis take late-stage ATTR-CM failure in Wainua trial
AstraZeneca reported that Wainua, its drug for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) developed with Ionis Pharmaceuticals, failed to outperform placebo in a pivotal trial. The...
Phase 3 ensartinib trial delivers major disease-free survival gain after resection
In a Phase 3 trial reported in the medical literature, ensartinib improved disease-free survival in patients with completely resected ALK-positive stage IB to IIIB non–small-cell lung cancer...
Big Pharma dealmaking: Bioptimus emerges from stealth with seed and multimodal plans
French AI startup Bioptimus said it is building a foundation-model approach to predict spatial gene expression and downstream tumor and patient behaviors from H&E tissue slides and transcriptomic...
Big trial miss in COPD as AstraZeneca locks $2.1B Sino rights to TQC-3721
AstraZeneca secured ex-China rights to Sino Biopharmaceutical’s PDE3/4 inhibitor candidate TQC-3721 for up to $2.1 billion, bolstering its COPD pipeline with a late-stage small molecule. The deal...
Satellos readies Duchenne AAK1 strategy with adult Trailhead interim data
Satellos Bioscience released six-month interim adult Phase 2 data from its Trailhead study of SAT-3247, an oral AAK1 inhibitor in adults with Duchenne muscular dystrophy (DMD). In a small subset...
FDA regulatory process shift: FDA pauses new CRL releases to formalize policy basis
The FDA paused new releases of some unapproved-drug rejection letters (complete response letters, or CRLs) while it works to formalize the legal basis for disclosing the agency’s rationale. The...
Gene-editing companies settle dispute: Prime prevails vs Beam to start AATD trial
Prime Medicine reported victory in an arbitration dispute with Beam Therapeutics over gene-editing technology tied to an alpha-1 antitrypsin deficiency (AATD) program. Arbitrators determined...
FDA clears first-in-human phase I for LTZ-232 in metastatic colorectal and solid tumors
LTZ Therapeutics said the FDA cleared its IND for LTZ-232, enabling initiation of a Phase 1 study in patients with advanced metastatic colorectal cancer and other solid tumors. The clearance puts...
Cardiovascular late-stage failure
AstraZeneca and Ionis Pharmaceuticals reported that their antisense heart disease candidate, Wainua, missed its primary endpoint in a pivotal late-stage trial in transthyretin-mediated amyloid...
Regulatory approval in IgA nephropathy
The FDA granted Vera Therapeutics accelerated approval for TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The decision is...
Oncology: adjuvant ALK-positive lung cancer
A phase 3 trial evaluating ensartinib in completely resected ALK-positive non-small-cell lung cancer (NSCLC) reported a strong disease-free survival benefit at 24 months. In patients with stage II...
Oncology: PARP inhibitor in HR-deficient TNBC and ovarian cancer
In the EMBRACE phase 2 study, researchers reported efficacy for olaparib in metastatic triple-negative breast cancer (TNBC) and platinum-sensitive relapsed ovarian cancer with homologous...
Immunotherapy adverse-event management
Seres Therapeutics reported early phase findings for SER-155, a live biotherapeutic designed to address immune checkpoint inhibitor-related enterocolitis (irEC). The approach targets a clinical...
Biotech M&A: Vertex expands into endocrinology
Vertex Pharmaceuticals agreed to acquire Crinetics Pharmaceuticals in a $10 billion cash deal, moving Vertex to a fifth commercial pillar with an endocrine disease focus. The transaction adds the...
Antibody delivery & manufacturing policy shift
The FDA paused new releases and moved to shore up the legal basis for releasing complete response letters (CRLs), following a citizen’s petition from an unnamed pharma company. The change reflects...
Clinical pipeline regulation in rare diseases (US FDA retraction reversal)
FDA reversed course in an ultra-rare disease filing decision, clearing Saol to resubmit an NDA rather than run a new clinical trial. The shift is described as another “Makary era” reversal,...
Cell therapy manufacturing capacity in the US
OrganaBio expanded autologous cell therapy logistics by opening a local PBMC isolation and cryopreservation site in San Diego. The facility is designed to isolate and cryopreserve PBMCs within...
Drug discovery AI: Bioptimus foundation model push
French AI startup Bioptimus emerged with foundation-model ambitions in biology, developing spatial gene-expression and tumor-behavior predictors from H&E slides and bulk RNA sequencing. The...