SG-001 — IND submission
2026
We anticipate submitting a pre-Investigational New Drug ("IND") package to the FDA in fiscal year 2026, which could enable us to progress development of SG-001 directly into a registrational clinical trial.Source filing
ADMA biotech catalysts & pipeline
ADMA BIOLOGICS INC · Data as of 2026-09-08
Upcoming catalysts
SG-001 — FDA meeting
by year-end
ADMA continues to advance plasma collection optimization, potency assay development and preclinical activities supporting planned conformance lot production during the second half of 2026, ahead of the anticipated submission of its pre-Investigational New Drug (IND) meeting package to the U.S. Food and Drug Administration by year-end.Source filing
immune globulin intravenous, human – slra — Conference presentation
Nov 12–Nov 16
The study's findings demonstrated that patients experienced statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use and corticosteroid use following ASCENIV administration, and the findings have been submitted as an abstract to the November 2026 American College of Allergy, Asthma & Immunology ("ACAAI") Annual Scientific Meeting.Source filing