Sarepta posted $442.9 million in revenue for Q4 2025, down from $658.4 million in the year-ago quarter but beating the consensus Wall Street estimate.

So far, in a Phase I trial, incidents of CRS have been low grade on VIR-5500, and 14 of 17 evaluable patients saw more than a 50 percent decrease in PSA levels.

The decision to withdraw the gene therapy, which recorded only $36 million in sales in 2025, led to $240 million in restructuring charges in Q4.

In an early-stage clinical trial, half the patients with advanced undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma responded to the TIL therapy.

The firm is anticipating FDA approval for the bispecific antibody in HER2-positive gastroesophageal cancer this year and advancing the treatment in breast cancer studies.

The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...

Regenxbio and the trustees of UPenn in 2020 filed a patent infringement lawsuit alleging Sarepta was illegally using patented tech in its Duchenne gene therapy.

Researchers are evaluating the P-CARE model, which integrates results from a blended genome-exome sequencing assay and family ...

In a study with three UK academic institutions, the platform agreed with MDx results 94 percent of the time in detecting ...

Phase III data show the Braftovi regimen significantly improves overall survival and response versus chemo as a frontline treatment for advanced tumors.

NEW YORK – The European Commission on Monday approved Johnson & Johnson's subcutaneous Rybrevant (amivantamab) in two new dosing schedules as a first-line treatment for patients with advanced ...

The FDA also accepted Gilead's BLA seeking the cell therapy's approval in multiple myeloma and will decide whether to approve it by December.