Press release
Catalyst Biosciences Receives Rare Pediatric Disease Designation for CB 4332 for the Treatment of CFI Deficiency
SOUTH SAN FRANCISCO, Calif., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced the U.S. Food and Drug Administration
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for CB 4332 for the treatment of Complement Factor I (CFI) deficiency (CFID). “The granting of the Rare Pediatric Disease Designation for CB 4332 underscores the significant unmet medical need in pediatric patients with CFID. We are focused on efficiently advancing the development of CB 4332 and our complement medicines portfolio in a number of complement-driven diseases in hematology, nephrology and ophthalmology. We are pleased with the FDA’s assessment of CB 4332 as a potential therapy for underserved pediatric patients with CFID and the granting of the RPDD,” said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences. Under the FDA's rare pediatric disease designation program, the FDA may grant a priority review voucher to a sponsor who receives a product approval for a rare pediatric disease. A rare pediatric disease is defined as a serious or life-threatening condition that affects less than 200,000 individuals in the U.S. per year and who are primarily less than 18 years of age. About Catalyst Biosciences, the Protease Medicines companyCatalyst is a research and clinical development biopharmaceutical company focused on developing protease therapeutics to address unmet medical needs in disorders of the complement system. Proteases are natural regulators of this biological system. We engineer proteases to create improved or novel molecules to treat diseases that result from dysregulation of the complement cascade. Our complement pipeline consists of several proteases that regulate the complement cascade including our improved Complement Factor I protease CB 4332 for patients with deficiencies in CFI, a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration (dAMD), and proteases from our ProTUNE™ C3b/C4b degrader and ImmunoTUNE™ C3a/C5a degrader platforms designed to target other disorders of the complement or inflammatory pathways. Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include, without limitation, those regarding plans for clinical developm...