Adma Biologics, Inc. ADMA
Adma Biologics, Inc. (Nasdaq: ADMA) is an immunology/inflammation drug developer. Its lead program, ASCENIV (Immune Globulin Intravenous, Human - slra 10% Liquid), is in Pre-clinical for Primary humoral immunodeficiency (PI/PIDD). Its next catalyst on record is SG-001: Submission of pre-IND package to FDA (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: SG-001 — Submission of pre-IND package to FDA (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ASCENIV (IVIG) | Primary humoral immunodeficiency; FDA approved April 2019, pediatric (age 2+) label expansion announced May 2026 | biologic-other | Approved |
| BIVIGAM (IVIG) | Primary humoral immunodeficiency; FDA approved May 2019, pediatric label expansion December 2023 | biologic-other | Approved |
| Nabi-HB (Hepatitis B Immune Globulin, Human) | Acute exposure to blood containing HBsAg and other listed hepatitis B exposures; FDA approved March 1999 | biologic-other | Approved |
| SG-001 (S. pneumoniae hyperimmune globulin) | Prevention/treatment of S. pneumoniae infection | biologic-other | Pre-clinical |
Recent results and decisions
- May 4, 2026approval FDA approved ADMA's sBLA expanding the ASCENIV label to pediatric PI patients aged 2 years and older (previously 12+).
Additionally, the approval provides for a revision of ASCENIV’s prescribing information to expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients two years of age and older.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other pre-clinical immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.