high-dose sublingual aspirin product — NDA/BLA submission
late 2026
These results will be the backbone of a 505(b)(2) submission to the FDA planned for late 2026.Source filing
ASBP biotech catalysts & pipeline
ASPIRE BIOPHARMA HOLDINGS INC · Data as of 2026-10-25
Upcoming catalysts
testosterone — FDA meeting
Q4 2026
Aspire anticipates, based on these results, to request a pre-IND meeting with the FDA in the fourth quarter of 2026, followed by Phase Two clinical testing.Source filing
testosterone — NDA/BLA submission
Q4 2026
Aspire intends to submit an NDA for the testosterone product under 505(b)(2) to the FDA in the fourth quarter of 2026 at the earliest.Source filing
aspirin — NDA/BLA submission
2027
These results will be the backbone of a 505(b)(2) submission to the FDA planned for the first six months of 2027, once the next clinical trial is concluded.Source filing