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May 7, 2024

Second patient death in Pfizer’s DMD gene therapy studies renews safety concerns

It’s not yet clear if the new patient death Pfizer reported in Phase II DAYLIGHT study of fordadistrogene movaparvovec is treatment-related

Product Development

Clinical report: Calliditas data provide mixed support for anti-fibrotic cancer mechanism

Plus: J&J aiming to replace bladder cancer surgery with TAR-210, and updates from Merck, GlycoMimetics, EyePoint and more

Emerging Company Profile

Xaira’s $1B AI play: de novo antibodies now, causal biology to follow

Xaira will initially aim Baker tech at validated targets; functional genomics and patient data are its plan for “breaking the system” for target discovery

Regulation

Another step in what could be the path to the first Barth syndrome therapy

FDA grants priority review to Stealth’s therapy, removing uncertainty over a priority review voucher needed for economic viability in the ultra-rare disease

Management Tracks

Seaport rounds out C-suite with new hires

Plus: Germany-based Topas taps new CEO, and updates from Quest, Nimbus and more

BioCentury ISSN 1097-7201