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Autoimmune and multispecific T-cell engager collaborations
Vertex Pharmaceuticals and AbCellera announced a new collaboration to discover, develop, manufacture and commercialize multispecific T-cell engagers for autoimmune diseases and other...
Commercial-stage performance and guidance momentum at Biogen
Biogen said Leqembi logged its best quarter since launch, following strong global sales momentum. The company reported $184 million in global sales for Leqembi in the second quarter and raised or...
FDA scrutiny and advisory committee pressure for Duchenne cell therapy
The FDA’s Cellular, Tissue and Gene Therapies advisory committee is set to review Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy deramiocel (deramiocel). Ahead of the meeting, an...
Big biotech deal expands immunology pipelines
argenx agreed to acquire Forte Biosciences for about $2.2 billion in cash, betting that Forte’s lead asset FB102 can broaden its immunology franchise across multiple autoimmune indications. The...
IPO push in sleep apnea with FDA acceptance for a neuromuscular OSA pill
Apnimed filed for an IPO to fund the commercial path for Oxnimbi (AD109), an oral therapy for obstructive sleep apnea aimed at boosting neuromuscular pathways rather than mechanically propping...
Cell therapy manufacturing scale-up for AAV retinal gene therapy
Forge Bio agreed to partner with Restore Vision to advance AAV gene therapy manufacturing for retinitis pigmentosa. Under the deal, Forge will tailor AAV process development and conduct clinical...
Gene editing and safety benchmarking for CRISPR-edited therapies
A multi-site study published in Gene Therapy evaluates two streamlined assays—SACF and GILA—designed to improve how teams detect unintended transformation risks from CRISPR/Cas9-edited cell...
Hospital diagnostics expansion: blood-based colorectal screening approval
Freenome said the FDA approved its SimpleScreen blood-based colorectal cancer screening test, extending access for average-risk adults who are currently underserved by existing screening...
Oncology immunotherapy trial support to avoid cystectomy in BCG-unresponsive bladder cancer
A Mayo Clinic-led international Phase 3 trial reported that cretostimogene grenadenorepvec, an intravesical oncolytic immunotherapy, may help some patients with high-risk, BCG-unresponsive...
AI-powered point-of-care diagnostics funding for COPD detection
Tidalsense raised $19 million to expand adoption of N-Tidal Diagnose, an AI-powered platform designed to identify COPD in about five minutes. The diagnostic workflow combines rapid acquisition...
Regulatory scrutiny for FDA advisory committee decisions
The FDA is signaling continued doubts about Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy deramiocel ahead of a Cellular, Tissue and Gene Therapies Advisory Committee meeting. In...
Biotech IPO and late-stage clinical momentum
Apnimed filed for a $160 million initial public offering as it prepares for a potential commercial launch of its oral obstructive sleep apnea therapy, AD109 (Oxnimbi). The Cambridge,...
M&A reshapes immunology pipeline portfolios
Argenx agreed to acquire Forte Biosciences for about $2.2 billion in cash, expanding its immunology platform with FB102, an anti-CD122 monoclonal antibody. The deal values Forte at $77 per share,...
Orphan gene-edited cell therapy manufacturing scaling
Cellares and Papillon Therapeutics partnered to scale manufacturing for Papillon’s genome-edited cell therapy PPL-001 in Friedreich’s ataxia. The CDMO deal centers on transferring the therapy into...
CDMO capacity and process execution for AAV retinal gene therapy
Forge Bio partnered with Restore Vision to advance AAV therapies for inherited retinal disorders, with Forge supporting manufacturing for the lead candidate RV-001. The CDMO collaboration includes...
Diagnostics and regulatory approval for colorectal cancer screening
Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, received FDA approval, positioning the assay as a complementary option to stool-based screening. The company said the...
Gene therapies and AI-designed oncology candidates move toward clinical readouts
Insilico Medicine said first-in-human Phase 1 data for ISM6331 have been accepted for a Rapid Oral presentation at the 2026 ESMO Congress. ISM6331 is described as an AI-designed pan-TEAD...
Clinical trial signal for metabolic overlap in alcohol use disorder
Altimmune reported that pemvidutide, a GLP-1/glucagon receptor agonist, reduced heavy drinking days in a Phase 2 alcohol use disorder trial versus placebo. The company said the result was...
Protein and genome editing AI tooling expands for next-gen therapeutics
A new protein design control method, ProteinGuide, was described as enabling researchers to steer protein sequence generative models using auxiliary experimental or user-specified information...
Platform investment: expanded access to precision DNA synthesis
DNA Script expanded on-demand DNA synthesis access in India through a distribution agreement with Imperial Life Sciences. Under the deal, ILS will distribute DNA Script’s SYNTAX platform across...