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Phase 3 setback — Angelman syndrome antisense program fails
Ultragenyx said its Phase 3 study in Angelman syndrome failed to meet both primary and key secondary goals for apazunersen (GTX-102). The result sharply escalates uncertainty around the program’s...
Big pharma licensing deal — GSK steps further into ADCs
GSK agreed to license Hutchmed’s KRAS/EGFR antibody conjugate HMPL-A830 in a deal valued up to about $1.295 billion, plus royalties. The transaction expands GSK’s ADC ambitions beyond its current...
Phase 3 readout — Novartis remibrutinib enters relapsing MS race
Novartis’ remibrutinib delivered positive top-line Phase 3 results in relapsing multiple sclerosis, making it the second oral Bruton’s tyrosine kinase inhibitor to post favorable efficacy data in...
Big pharma delivery deal — Novartis licenses Alteogen’s ALT-B4
Novartis agreed to use Alteogen’s Hybrozyme-based ALT-B4 enzyme platform to support subcutaneous delivery of multiple biologics, in a deal worth up to $3.2 billion. The agreement underscores...
ADC deal — Pfizer sells discontinued Seagen asset to Medicus
Pfizer offloaded a scrapped Seagen antibody-drug conjugate to Medicus Pharma under a transaction that could reach more than $1 billion. The move follows Pfizer’s acquisition of Seagen in a $43...
FDA regulation and enforcement — CBER overrules rejection for Replimune melanoma drug
New agency documents show the FDA’s Center for Biologics Evaluation and Research granted an accelerated approval for Replimune’s melanoma treatment Tudriqev after an FDA official overruled an...
Cell therapy risk — CAR-T safety pause after Novartis and Bristol Myers study
Autoimmune CAR-T programs face new caution after a study involving Novartis and Bristol Myers announced a pause tied to safety concerns. The report raises questions for manufacturers about trial...
Platform funding — Typewriter raises Series A for in vivo RNA CAR-T
Typewriter Therapeutics emerged from stealth with a $56 million Series A financing focused on in vivo RNA-based gene therapies for cancer, autoimmune disease, and severe genetic disorders. The...
Preclinical neuroscience — psilocybin prevents chemotherapy-induced peripheral neuropathy in mice
Researchers at UT MD Anderson reported in Science that psilocybin prevented chemotherapy-induced peripheral neuropathy in mouse models. The team reported durable protection across multiple...
Huntington’s gene therapy regulatory path
UniQure submitted applications to the FDA and the UK’s MHRA seeking approval for AMT-130, its gene therapy for Huntington’s disease, after previously disclosed three-year data showed slowed...
Cancer drug partnering: Roche expands TCE pipeline
Roche signed an exclusive global licensing agreement with Simcere Zaiming Pharmaceutical for SIM-0660, a preclinical trispecific T-cell engager targeting CD79a, CD19 and CD3. Under the deal,...
GSK doubles down on KRAS/EGFR targeted oncology
GSK agreed to license Hutchmed’s KRAS-EGFR antibody-targeted therapy conjugate HMPL-A830, paying $110 million upfront with total deal value up to $1.295 billion plus royalties. The asset is...
Drug delivery platform deals: Novartis and Alteogen for subcutaneous formulations
Novartis licensed Alteogen’s ALT-B4 (berahyaluronidase alfa) subcutaneous drug delivery technology in a deal worth up to $3.2 billion. The agreement provides Novartis option rights to develop and...
Clinical failure forces cost resets at Ultragenyx
Ultragenyx’s experimental therapy GTX-102 for Angelman syndrome failed in a Phase 3 trial, showing no benefit versus sham treatment. The company said it is now weighing “significant” cost cuts as...
AI biology funding: ARPA-H pushes on-demand RNA manufacturing
ARPA-H awarded up to $125 million under its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program to build a domestic, automated network for manufacturing individualized,...
AI-assisted oncology platform: drug discovery speed at large scale
St. Jude Children’s Research Hospital, University of Pavia, Dana-Farber Cancer Institute and Harvard Medical School unveiled AdaptiveFlow, an AI-informed platform claimed to virtually screen...
Liquid biopsy startup raises seed for RBC-bound nucleic acids
Senticell closed an oversubscribed seed financing approaching $7 million to advance its RBC-bound nucleic acid liquid biopsy platform. The company is licensing the technology exclusively from the...
Gene therapy manufacturing partnerships: Andelyn scales Genprex AAV diabetes program
Genprex selected Andelyn Biosciences to support manufacturing scale-up for its diabetes gene therapy program, which uses an AAV vector delivered via the pancreatic duct. Under the agreement,...
Clinical translational AI: mechanistic mapping for drug discovery
Constructor University and Constructor Labs introduced BiteNetI, a deep-learning model designed to map ion binding sites directly onto three-dimensional protein structures. The tool, described as...
FDA accelerated approval override for melanoma drug
The FDA overruled an internal review decision and granted accelerated approval to Replimune’s melanoma therapy, Tudriqev (tudriqev, reportedly tied to the company’s Replimune platform). According...