Summary Regeneron has received FDA approval for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for genetic hearing loss caused by biallelic OTOF variants, marking a major milestone in sensory-organ gene therapy. What Happened The FDA approved Otarmeni for patients with…
Summary Cartherics and Catalent have expanded their manufacturing partnership to support development and commercialization of iPSC-derived CAR-NK cell therapies. The agreement strengthens access to Catalent’s cGMP-compliant iPSC platform, supporting multiple programs including lead candidate CTH-401. What Happened Cartherics entered an…
Summary Life Biosciences has raised $80 million to support clinical development of its anti-aging gene therapy program, marking a notable financing event in the longevity and gene therapy space. What Happened The company secured $80M in financing to advance its…
Summary The FDA has extended the review timeline for Orca Bio’s biologics license application (BLA) for Orca-T, a high-precision allogeneic cell therapy for hematologic malignancies. The updated PDUFA date has been moved from April 6, 2026 to July 6, 2026…
Summary The RNA therapeutics field is approaching a key inflection point with the anticipated initiation of the first clinical trial of engineered transfer RNA (tRNA) therapy, led by emerging players such as Alltrna. This modality targets nonsense mutations, representing a…
Summary Fortress Biotech, through its subsidiary Cyprium Therapeutics, has completed the sale of a Rare Pediatric Disease Priority Review Voucher (PRV) for $205 million following the FDA approval of ZYCUBO (copper histidinate) for Menkes disease. The transaction represents a significant…
