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Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
The biotech, which has a deal with Eli Lilly worth as much as $1.1 billion, is developing two targeted radiopharmaceuticals from its miniprotein radioconjugate platform.
The biologics center director reportedly became personally involved after the team reviewing the rare blood disorder filing asked for an extension to the CNPV-accelerated timeline.
Ceralasertib is part of AstraZeneca’s ambitious plan to hit $80 billion in revenue by 2030.
Jacobio discovered JAB-23E73, which is designed to treat several KRAS mutation subtypes, and is testing the therapy in multiple Phase I trials.
Stifel analysts said the label for cardiac myosin inhibitor Myqorzo is in line with their expectations and is differentiated compared with BMS’ Camzyos.
Pfizer and Metsera, Sarepta and uniQure made the list with dramatic tales. The other two spots went to the regulatory challenges facing biopharma under the new administration, especially in the vaccines sector.
The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
A report from analysts at Jefferies suggested that new screenings for metachromatic leukodystrophy and Duchenne muscular dystrophy could bump sales of the gene therapy Libmeldy by more than $100 million.
BioMarin Pharmaceutical has faced a rocky road, promising and then backing off revenue targets and cutting assets that have underperformed. But Amicus’ rare disease portfolio is already bringing in $600 million annually.
PRESS RELEASES
Xbiom™ Platform Introduces AI-Enabled Automated Workflow that Eliminates Redundant Processes, Reduces Costs by 50%, and Accelerates IND-Enabling Regulatory Submission Readiness by 2-4 Weeks
This partnership will establish a new research and production facility in Andhra Pradesh, driving India’s transition toward pharmaceutical leadership and creating high-tech jobs
Includes Asthma in its strategic plans and Strengthens its Team in 2024-2025
Enrollment momentum accelerates as Company advances toward full enrollment