GRI Bio, Inc. GRI
GRI Bio, Inc. (Nasdaq: GRI) is a respiratory drug developer. Its lead program, GRI-0621, is in Phase 2 for Idiopathic pulmonary fibrosis (IPF). Its next catalyst on record is GRI-0803: Complete IND-enabling studies, file IND, and begin Phase 1a/1b trial in healthy volunteers (H1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: GRI-0803 — Complete IND-enabling studies, file IND, and begin Phase 1a/1b trial in healthy volunteers (H1 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| GRI-0621 (oral tazarotene, iNKT cell inhibitor) | Idiopathic pulmonary fibrosis | small molecule | Phase 2 |
| GRI-0803 (type 2 NKT agonist) | Autoimmune disorders, initially lupus (SLE) | small molecule | Pre-clinical |
Recent results and decisions
- Jun 18, 2026n/a FDA granted Orphan Drug Designation to GRI-0621 for idiopathic pulmonary fibrosis.
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive, irreversible and ultimately fatal lung disease affecting tens of thousands of patients in the United States.
Filing - Dec 8, 2025positive Phase 2a met primary safety/tolerability endpoint; placebo-adjusted FVC +99 mL (+139 mL with standard of care) at 12 weeks; 39% of treated had FVC increase vs 80% of placebo declining.
This topline data indicates that the trial met its primary endpoint and certain secondary endpoints that have been evaluated to date demonstrating that GRI-0621 was well tolerated over a 12-week treatment period, consistent with earlier studies evaluating over 1,700 subjects treated for up to a year
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 phase 2 respiratory 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.