Avexitide Advancements in Phase III LUCIDITY Trial
Successfully dosed first participant in pivotal Phase III LUCIDITY trial for post-bariatric hypoglycemia (PBH). Recruitment expected to complete by year-end, with anticipated commercial launch in 2027 if approved.
Positive Developments in AMX0035 Trials
Long-term Week 48 data for AMX0035 in Wolfram syndrome showed sustained stabilization or improvement. Phase IIb data from PSP trials expected this quarter to inform Phase III decisions.
Financial Stability and Reduced Operating Expenses
Cash position of $180.8 million, with operating expenses down 43% from the same period in 2024. Cash runway expected to last through the end of 2026.
FDA Fast Track Designation for AMX0114
The FDA granted Fast Track designation to AMX0114 for ALS, allowing for more frequent interactions with the FDA and potential for expedited review.
Significant Reduction in Hypoglycemic Events with Avexitide
Avexitide led to a 64% reduction in hypoglycemic events in Phase II trials, with more than half of participants experiencing no Level 2 or Level 3 hypoglycemic events during treatment.