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Biotech finance – cash runway for gene therapy & pipeline moves
Encoded Therapeutics secured a $275 million Series F to advance its lead gene therapy ETX101 for Dravet syndrome, targeting infants and children with SCN1A-positive disease. The capital also funds...
Regulatory – CVOT setbacks and evolving target confidence in cardiology
A BioCentury roundup highlights the latest blow to cardiovascular outcomes trial expectations after Novartis’ Horizon program failure, while underscoring how CVOT setbacks are shaping what targets...
Immuno-oncology – CTLA-4 next-generation launch
Solstice Oncology emerged from stealth with a $225 million Series A to advance porustobart, a next-generation CTLA-4 antibody designed to extend immunotherapy into microsatellite-stable colorectal...
Clinical development – antibody-drug conjugate dosing step in EGFR-mutated lung cancer
An investigational antibody-drug conjugate targeting two growth-driving proteins in lung cancer reached a recommended Phase 3 dose in EGFR-mutated disease after resistance to targeted therapy,...
Platform & manufacturing – improved bioprocess intensification licensing
Transcenta Therapeutics licensed key technologies in its intensified continuous bioprocessing (HiCB) platform and ExcelPro media to WuXi Biologics and its affiliates to accelerate...
Diagnostics regulation – FDA clearance delay for AI heart failure software
Echo IQ Ltd. disclosed that the FDA issued a not substantially equivalent determination for its initial 510(k) submission covering Echosolv HF, an AI-based heart failure clinical decision support...
M&A – Axogen to acquire Biocircuit
Axogen agreed to acquire Biocircuit Technologies for $200 million in cash to expand its peripheral nerve repair portfolio. The acquisition is expected to bring Nerve Tape, the first U.S....
Biomarker strategy – liquid biopsy approach for NSCLC research
AGEN-style educational content highlights growing use of high-sensitivity droplet digital PCR (ddPCR) for variant detection and quantification in NSCLC biomarker workflows, including research and...
Device & monitoring – FDA breakthrough status for antibiotic monitoring patch
Nutromics received FDA breakthrough device designation for its wearable patch designed to track vancomycin levels in real time. The company’s aim is to reduce reliance on periodic blood draws used...
SMA muscle-loss therapy gets FDA nod
The FDA approved Scholar Rock’s Isembyld (myostatin inhibition) for adults and children 2 years and older with spinal muscular atrophy (SMA) who are receiving SMN2-targeting therapies. The...
Novartis setbacks spread across cardiovascular and neuromuscular programs
Novartis reported a Phase 3 setback for delpacibart etedesiran (del-desiran), its antibody-oligonucleotide conjugate targeting myotonic dystrophy type 1 (DM1), missing primary endpoints in the...
FDA signals reconsideration on AI-based cardiac decision support
The FDA issued a not substantially equivalent determination for Echo IQ’s initial 510(k) application for Echosolv HF, its AI-based heart failure clinical decision support software, delaying US...
Cancer immunotherapy and regulatory expansion: Bayer’s Hyrnuo label broadens
The US FDA granted an expanded accelerated approval for Bayer’s Hyrnuo (sevabertinib) to treat adults with locally advanced or metastatic nonsquamous non-small cell lung cancer harboring HER2...
Samsung Biologics locks long-term manufacturing deal
Samsung Biologics signed a $262 million manufacturing agreement with an unnamed European pharmaceutical company, with production commitments scheduled through 2033 at Samsung’s Songdo site in...
Dealmaking and funding: Solstice grows CTLA-4 oncology platform
Solstice Oncology emerged from stealth with a $225 million Series A to advance porustobart, a next-generation CTLA-4 antibody designed for immunotherapy use in microsatellite-stable (MSS) colon...
Genome engineering continues: CRISPR-style epigenome rewiring for cancer
Researchers reported a CRISPR methylation editing approach that they say rewrites the cancer epigenome toward causal mechanisms. The work focuses on modifying DNA methylation patterns to probe how...
Cell therapy manufacturing collaboration in Japan
Teijin, Teijin Regenet, and Shinshu University Hospital entered a joint research agreement targeting manufacturing technologies for cell and gene therapy products, including CAR T. The...
Clinical trial disruption risk: persistent cancer drug shortages
STAT+ reported that cancer centers are grappling with persistent drug shortages that continue to disrupt patient care, with drug availability issues intersecting with how clinicians receive and...
AI for biosensing: wearable vancomycin monitoring gets FDA breakthrough status
Nutromics received FDA breakthrough device designation for its wearable patch designed to monitor vancomycin drug levels in real time. The goal is to replace or reduce periodic blood draws used to...
FDA approvals in rare diseases
The FDA has approved Scholar Rock’s Isembyld (myostatin inhibition) as the first therapy specifically targeting muscle loss in spinal muscular atrophy (SMA), covering adults and children 2 years...