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Regulatory and trial scrutiny in Duchenne muscular dystrophy
FDA is signaling major concerns around Capricor Therapeutics’ Duchenne muscular dystrophy stem-cell therapy deramiocel after questioning whether Phase 3 objectives were met, according to the...
Leadership shakeups at commercial oncology and cell therapy companies
Legend Biotech has abruptly changed leadership, with CEO Ying Huang stepping down without a permanent replacement named. The board appointed Carvykti president Alan Bash as interim CEO, beginning...
Immunology M&A accelerates with Argenx’s acquisition of Forte
Argenx agreed to buy Forte Biosciences for $2.2 billion in cash, expanding its immunology pipeline via Forte’s anti-CD122 monoclonal antibody FB102. The deal values Forte at $77 per share and...
Corporate restructuring and CEO change at a Duchenne-focused biotech
Sarepta Therapeutics named Michael Severino, formerly CEO of Tessera Therapeutics, as its chief executive starting Tuesday. Severino replaces Doug Ingram, who announced plans to retire after...
AI-driven diagnostics and reimbursement infrastructure funding
Candid Health secured $120 million for its AI-enabled revenue cycle management platform, extending the push to automate coding, documentation, and claims workflows. The Series D round was led by...
Therapeutic pipeline revival in rare brain disease funding
RA Capital and other investors put $175 million into Oak Hill Bio to revive an Angelman syndrome program previously shelved by Roche. Oak Hill is positioning the therapy against competing Phase 3...
Nasdaq listing compliance pressures hit protein sequencing and in vitro diagnostics
Quantum-Si received a Nasdaq delisting notice after its stock traded below $1 for 30 consecutive business days, according to an SEC filing. The single-molecule protein sequencing company has 180...
Nasdaq compliance notice adds pressure to diagnostics test portfolio
MDxHealth disclosed it has received an additional Nasdaq notice of noncompliance related to minimum market value for continued listing. The diagnostics company previously warned that its stock...
Large pharma uses AI in late-stage development – AZ reports setbacks in pipeline
AstraZeneca said it is leaning on AI to reduce risk and speed filings in late-stage development, even as it acknowledged late-stage setbacks in parts of its pipeline. CEO Pascal Soriot said AZ’s...
Immunology licensing and biologics pipeline repositioning via European foundation funding
Denmark’s biotech footprint is expanding, driven by foundation-backed capital allocation, talent depth, and an incubator-to-venture pipeline centered on the Novo Nordisk Foundation ecosystem....
Immunology M&A accelerates pipeline
argenx agreed to buy Forte Biosciences for $2.2 billion in cash, valuing Forte at $77 per share and marking a continuation of deal momentum across mid-cap immunology. The acquisition is designed...
Company finance – IPO with pharma tie-up
Scribe Therapeutics priced an upsized $128.7 million IPO, increasing the share count after an initial public offering launched at $15 per share. Underwriters led by Leerink Partners, Goldman...
Clinical development funding – pivotal testing for gout
Crystalys Therapeutics raised $130 million to support pivotal testing for its gout drug dotinurad, a molecule in late-stage work for an inflammatory disease with limited options. The funding is...
Patient safety and therapeutics – device-based monitoring and delivery
A closed-loop theranostic patch designed for chronic wound care combines hydrogel dressing materials with flexible electronics to monitor wound status and dynamically adjust response. The approach...
Artificial intelligence in care prediction
Researchers reported a multicenter large language model that predicts acute kidney injury (AKI) and offers explainable risk attribution across hospital sites. The system is trained on diverse...
Health systems – Rethinking hospital preparation for treatment continuity
Oncologists warned that chemotherapy shortages are forcing substitutions and workarounds that can compromise care. The report highlights supply constraints for several critical generics, including...
Immunotherapy discovery – spatial mapping for response biology
A spatial genomics approach called Slide-GoTags aims to improve precision in cancer immunotherapy by showing where neoantigen tumor cells and T-cell receptor (TCR) interactions colocalize within...
Gene therapy economics – AAV cost modeling for access planning
A new analysis charts how rAAV dose costs vary by indication and estimates capacity needs across six leading gene therapy targets, including RPE65 retinal dystrophy, AMD, hemophilia A and B, SMA,...
Biotech funding – AI platform for revenue cycle management
Candid Health raised $120 million in a Series D round to expand its AI platform for revenue cycle management (RCM). The financing was led by Sixth Street Growth, with participation from Oak HC/FT,...
Drug discovery tools – protein evolution with AI-designed starting points
A Nature study reported AI-designed protein redesigns that shift the “rules of evolution” in phage-assisted continuous evolution (PACE). The work applies controlled selection pressures to evolve a...