Latest Biotech News

Ultragenyx Pharmaceuticals disclosed that its Phase 3 Aspire trial of apazunersen (GTX-102) in Angelman syndrome failed to hit both primary and key secondary endpoints. The miss centered on change...

GSK agreed to license Hutchmed’s HMPL-A830, a dual-mode KRAS/EGFR cancer therapy conjugate, in a deal valued up to $1.295 billion. The agreement grants GSK’s subsidiary global rights to develop...

Akeso and Summit Therapeutics said updated Phase 3 data for ivonescimab cleared the overall survival bar in a specific lung cancer setting, building on earlier interim results that had raised...

Lindus Therapeutics, backed by Peter Thiel, is pivoting away from its CRO roots to pursue drug development and hunt for drug assets. The transatlantic startup had branded itself as an “anti-CRO”...

Novartis halted multiple CAR-T programs after three patient deaths tied to severe autoimmune reactions following dosing with rapcabtagene autoleucel (zola-cel) in autoimmune indications. The...

Pfizer is offloading a scrapped Seagen ADC to Medicus Pharma under an arrangement that could reach $1 billion-plus, according to the report. The move continues the broader reshaping of...

The Mucolipidosis Type IV (ML4) Foundation announced FDA IND clearance for the first U.S. clinical trial of an investigational gene therapy for mucolipidosis type IV (MLIV), an ultra-rare...

Watchmaker Genomics expanded manufacturing capacity by securing a long-term lease for about 100,000 square feet at Flatiron Park in Boulder, Colorado. The facility is designed to more than double...

Typewriter Therapeutics emerged from stealth with $56 million in Series A financing, focusing on RNA-based gene therapies aimed at patients with cancer, autoimmune disease, and severe genetic...

GSK signed a licensing agreement with HUTCHMED for HMPL-A830, an antibody-targeted therapy conjugate designed to deliver a KRAS small-molecule inhibitor to EGFR-expressing tumors. The deal gives...

GSK will pay $110 million upfront to license Hutchmed’s HMPL-A830, a preclinical KRAS/EGFR antibody conjugate designed for dual pathway blockade. Under the terms, GSK gets ex-China rights and...

The FDA approved Ionis Pharmaceuticals’ Zanvastro, the first disease-modifying therapy for Alexander disease, extending motor function stability versus decline in a pivotal trial. The approval...

Ultragenyx said its Phase 3 Aspire trial of apazunersen (GTX-102) in Angelman syndrome failed to meet both goals. The study did not achieve the primary endpoint—change from baseline in the...

Novartis’ remibrutinib became the second oral BTK inhibitor to post positive Phase 3 top-line results in relapsing multiple sclerosis. The readout positions the drug behind Roche’s fenebrutinib in...

Roche acquired exclusive global rights to Simcere Zaiming’s SIM-0600, a preclinical CD79a/CD19/CD3-targeting trispecific T-cell engager. The licensing agreement has a potential value of up to...

Novartis licensed Alteogen’s ALT-B4 (berahyaluronidase alfa) platform for subcutaneous drug delivery in a deal valued at up to $3.2 billion. The agreement grants option-based rights to develop and...

Novartis paused and is investigating multiple clinical trial programs for rapcabtagene autoleucel after three patient fatalities tied to severe autoimmune reactions. The events were associated...

UniQure filed applications with the FDA and the UK’s MHRA seeking marketing approval for AMT-130, its gene therapy targeting the underlying cause of Huntington’s disease. The company requested...

Watchmaker Genomics signed a long-term lease for about 100,000 square feet at Flatiron Park in Boulder, a move designed to more than double its manufacturing capacity. The expansion is intended to...

GSK moved deeper into antibody-targeted therapy conjugates by licensing Hutchmed’s preclinical HMPL-A830, a dual payload designed to combine EGFR targeting with KRAS inhibition. The deal is valued...