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Huntington gene therapy heads to FDA and seeks priority review
UniQure submitted applications to the FDA and the UK’s MHRA seeking marketing approval for AMT-130, its Huntington’s disease gene therapy. The company asked for priority review with a decision...
Phase 3 efficacy readout lifts Akeso’s lung cancer bispecific
Akeso and Summit announced updated Phase 3 overall survival data for ivonescimab, a PD-1xVEGF bispecific, after an interim OS update previously dented investor confidence. The companies said the...
ABBVIE’s multiple myeloma bispecific posts positive Phase 3
AbbVie reported positive Phase 3 results for its T-cell engager etentamig in relapsed/refractory multiple myeloma. The company said the bispecific improved response rates and progression-free...
Ultragenyx Phase 3 failure in Angelman syndrome
Ultragenyx said its Phase 3 trial of GTX-102 for Angelman syndrome failed to show benefit versus sham treatment. The setback follows earlier excitement from the program’s early results and raises...
Teva delivers positive celiac gluten-challenge toplines
Teva reported success in a gluten challenge study for an experimental antibody, saying a single injection significantly reduced intestinal damage in celiac disease patients after they ate gluten...
Roche lands Simcere trispecific TCE in large B-cell deal
Roche signed an exclusive global licensing agreement for Simcere Zaiming’s preclinical trispecific T-cell engager SIM-0660, in a deal valued at up to $1.53 billion. Roche will pay $75 million...
Novartis expands subcutaneous delivery tech with Alteogen
Novartis agreed to license Alteogen’s ALT-B4 (berahyaluronidase alfa) subcutaneous drug delivery platform via option agreements, with potential value up to roughly $3.2 billion. The deal is part...
ARPA-H funds automated custom RNA manufacturing network
ARPA-H announced up to $125 million in awards under its GIVE program to build a domestic, automated network capable of producing individualized on-demand RNA-based genetic medicines at low cost....
CAR-T manufacturing ‘scale-out’ bottleneck
A new industry analysis highlights the core commercialization challenge for CAR-T: scaling thousands of patient-specific manufacturing runs so they behave like one reliable system. The piece...
Funding for genetic obesity and early clinical testing
Superluminal Medicines raised a $60 million Series B to advance its genetic obesity program into Phase 1 testing, a move aimed at validating its approach in the competitive MC4R obesity space. The...
Big Pharma licensing bets on KRAS-EGFR antibody conjugates
GSK agreed to license Hutchmed’s KRAS-EGFR cancer drug for $110 million upfront, with potential biobucks payments of up to $1.185 billion tied to development and commercial milestones. The...
Ultragenyx’s Angelman program stumbles in Phase 3
Ultragenyx said its Phase 3 trial of GTX-102 for Angelman syndrome failed to meet its primary efficacy goal, showing no benefit versus sham treatment. The setback is a major inflection point for a...
FDA accelerated approval overturned—Replimune’s Tudriqev wins internal rebuke
FDA’s biologics office rejected and then reversed course on its review of Replimune’s melanoma therapy Tudriqev (Tudriqev), according to newly disclosed documents. The CBER official Asha Das,...
Gene therapy regulatory push—UniQure seeks FDA approval for Huntington’s AMT-130
UniQure submitted applications to the FDA and the UK MHRA seeking marketing approval for its Huntington’s gene therapy AMT-130, aiming for a priority review decision. The Dutch company is...
Large-scale delivery platform deal—Novartis taps Alteogen ALT-B4 for subcutaneous formulations
Novartis licensed Alteogen’s ALT-B4 platform for subcutaneous drug delivery in a deal that could reach up to $3.2 billion. The arrangement, structured through option agreements, gives Novartis...
Roche partnership in B-cell immunology—SIM-0600 trispecific TCE deal
Roche struck an exclusive global licensing agreement with Simcere Zaiming for SIM-0660, a preclinical trispecific T-cell engager targeting CD79a, CD19, and CD3, with up to $1.53 billion in total...
ARPA-H funding for on-demand automated RNA genetic medicines
ARPA-H awarded up to $125 million under its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, funding teams to build a domestic, automated network for on-demand...
Teva’s celiac antibody shows success in gluten-challenge mid-stage study
Teva reported positive topline results in a celiac disease gluten challenge study, saying its experimental antibody significantly reduced intestinal damage after patients consumed gluten for eight...
Exelixis secures Cabometyx exclusivity after Federal Circuit patent win
The U.S. Federal Circuit affirmed the validity of three patents protecting Exelixis’s Cabometyx (cabozantinib), securing the company’s exclusivity and expected delaying generic competition by at...
Gene therapy regulatory path
UniQure has submitted marketing-authorization applications to the FDA and the UK’s MHRA for AMT-130, its Huntington’s gene therapy candidate. The Dutch company is also requesting priority review...