ARM highlights record rector growth and resilience in 2020

The regenerative medicine and advanced therapies sector raised a record $19.9 billion in funding in 2020, fueling the broader biotech sector and driving a rapidly advancing pipeline of potentially transformative therapies, according to the Alliance for Regenerative Medicine’s (ARM) 2020 Annual Report released today.

Two new therapies received approval in 2020: Orchard Therapeutics’ (Nasdaq: ORTX), gene therapy Libmeldy (autologous CD34+ cells encoding the ARSA gene), by the European Medicines Agency, and Gilead Sciences (Nasdaq: GILD) subsidiary Kite’s Tecartus (brexucabtagene autoleucel) antigen receptor T-cell (CAR-T) therapy, by the Food and Drug Administration.

By the end of 2020, there were 152 ongoing Phase III trials worldwide in cell, gene, and tissue-based therapies. Regulatory decisions are expected on a record eight new Advanced Therapy Medicinal Products (ATMPs) – and on a total of 10 products across at least four geographies - in 2021, including Breyanzi, a Bristol Myers Squibb (NYSE: BMY) CAR-T therapy for relapsed or refractory large (lisocabtagene maraleucel) B-cell lymphoma that already received FDA approval in February.