Phase III data show deramiocel slowed upper limb decline by 54% in Duchenne muscular dystrophy. The FDA is re-evaluating the BLA with HOPE-3 results, with a submission of the clinical study report expected in February 2026.
Gilead Sciences reported Q1 2026 total product sales of $6.9 billion, up 5% year over year, with HIV revenue growing 10% to $5.0 billion. The company raised its full-year 2026 base business revenue guidance by $400 million to $29.4–$29.8 billion. Non-GAAP diluted EPS was $2.03, up 12%, while the company advanced its oncology and cell therapy pipeline.
The global growth and differentiation factors market is projected to grow at an 8.2% CAGR through 2035, driven by expanding cell therapy manufacturing. GMP-grade revenue is expected to surpass research-grade by 2030 as the industry transitions to clinical and commercial production.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Johnson & Johnson invests over $1 billion in a new Pennsylvania cell therapy manufacturing facility for cancer and neurological diseases. The expansion addresses growing demand for advanced therapies while highlighting workforce training challenges in GMP environments. Other developments include new cell line technology for viral vector production and CRISPR-edited CAR-T manufacturing partnerships.
The FDA has lifted a Complete Response Letter and resumed review of Capricor Therapeutics' Biologics License Application for deramiocel, setting a PDUFA date of August 22nd. The company ended 2025 with $318M in cash.
AstraZeneca announced a $15 billion investment in Chinese R&D facilities through 2030, elevating China to a global innovation hub, while former China chief Leon Wang faces charges for unlawful data collection, illegal trade, and medical insurance fraud.
Johnson & Johnson will invest over $1 billion to build a cell therapy manufacturing facility in Montgomery County, Pennsylvania, creating more than 500 jobs over 12 years as part of its $55 billion U.S. expansion plan.
Johnson & Johnson announced plans to invest more than $1 billion in a next-generation cell therapy manufacturing facility in Montgomery County, Pennsylvania, expected to create 500 jobs when fully operational in 2031.
PTC Therapeutics withdrew its resubmitted new drug application for Translarna in Duchenne muscular dystrophy after the FDA indicated the data was unlikely to meet the threshold for substantial evidence of effectiveness, marking the third unsuccessful US approval attempt.
