Argo Biopharma Receives FDA Fast Track Designation for BW-20805, an Investigational siRNA Therapy for the Treatment of HAE
SHANGHAI and NEW YORK, March 16, 2026 /PRNewswire/ -- Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage small interfering RNA (siRNA) therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its novel siRNA therapy BW-20805, for the treatment of hereditary angioedema (HAE).
BW-20805 is an investigational siRNA therapy that targets and significantly inhibits prekallikrein (PKK), a well-validated target for hereditary angioedema (HAE) treatment, offering the possibility of prevention of HAE attacks with a long-term effect. Argo Biopharma is currently conducting a global Phase II study in adult HAE patients. The Company anticipates primary completion of the Phase II study in the second half of 2026, followed by plans for a global Phase III study.
"Receiving FTD from the FDA highlights the significant unmet medical need for patients living with HAE and underscores the potential of BW-20805 as a novel therapeutic option," said Dr. Dongxu Shu, co-founder and Chief Executive Officer of Argo Biopharma. "We have generated a robust body of clinical evidence supporting BW-20805's potential, including recent open-label study results presented at the AAAAI Annual Meeting, which demonstrated that BW-20805 provides remarkable plasma PKK reduction and meaningful time-normalized HAE attack rate reduction. We look forward to advancing the clinical development of BW-20805 and bringing a potentially long-acting treatment option to patients as effectively as possible."
About Hereditary Angioedema (HAE)
Hereditary angioedema (HAE) is a rare genetic condition that causes sudden and unpredictable swelling in different parts of the body. In severe cases, it can affect the throat and become life-threatening, with a mortality rate of up to 40%. HAE affects about 1.5 people per 100,000 worldwide. Current prophylactic treatments are limited by frequent dosing, highlighting the need for long-acting, preventive therapies. BW-20805 targets human hepatic PKK mRNA to inhibit PKK gene expression, offering the potential for effective prevention of HAE attacks with a significant and longer-lasting therapeutic effect.
About Argo Biopharma
Argo Biopharma is a clinical-stage biotechnology company committed to developing next-generation RNAi therapeutics to provide better treatment options for patients worldwide. The company has established a robust and diverse pipeline of RNAi molecule candidates targeting a wide range of indications, including cardiovascular diseases, viral infections, metabolic conditions, and specialty/rare diseases. Currently, Argo Biopharma has seven RNAi candidates in clinical development.
