Celldex Therapeutics Inc. will not advance barzolvolimab (CDX-0159, barzo) in eosinophilic esophagitis (EoE) after taking a look at top-line data from the ongoing phase II effort. The study met its primary endpoint, proving barzo’s efficacy in depleting mast cells in the gastrointestinal (GI) tract, but this didn’t improve symptoms of EoE – a chronic inflammatory disease of the esophagus – which means mast cells are not a primary driver. Hampton, N.J.-based Celldex noted that barzo did turn up a favorable safety profile. Read More
With a few tweaks to the protocol, Rocket Pharmaceuticals Inc.’s phase II trial testing RP-A501 in Danon disease is expected to resume following the lifting of the clinical hold, issued by the U.S. FDA in May in response to the death of a patient in the pivotal gene therapy study. Read More
Quoted technology commercialization company Puretech Health plc is scouting for third parties to fund phase III development of deupirfenidone, after spinning the respiratory drug into a new startup, Celea Therapeutics. Read More
A new method for accelerating the maturation of neuronal cell models and brain organoids is poised to make it possible to track the etiology of neurodegenerative diseases that develop over decades. Read More
Generative AI drug discovery company Vantai Inc. could bring in more than $1 billion in a new collaboration with Halda Therapeutics Inc. Vantai already has collaborations with other companies, including Bristol Myers Squibb Co. (BMS), Janssen Pharmaceutica and Blueprint Medicines Corp. Read More
Remegen Co. Ltd. is out-licensing its VEGF/FGF dual-target fusion protein drug, RC28-E, to Santen Pharmaceutical (China) Co. Ltd. in a carve-out deal worth more than ¥1.3 billion (US$180 million). Read More
After announcing in April that it would discontinue development of its lead candidate, sozinibercept (OPT-302), in wet age-related macular degeneration (AMD), Opthea Ltd. has come to a settlement agreement that will allow it to avoid bankruptcy and continue operations. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Adaptive, Āshibio, Genentech, Genequantum, Henlius, Mereo, Roche. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Aldeyra, Altimmune, Antengene, Astrazeneca, Biontech, Iovance, Pfizer, PTC, Regenxbio, Sanofi. Read More
