Annexon Adds 24-Month Endpoint to Phase 3 GA Trial, Launches Extension Study
ANNX has more than doubled off its 52-week low of $2.03 on light trading volume (0.3× avg).
Summary
Annexon is strengthening its Phase 3 ARCHER II trial for vonaprument in geographic atrophy by adding a Month 24 dual primary endpoint alongside the existing Month 15 endpoint. This design allows the trial to succeed at either timepoint, increasing the odds of a positive outcome. The company also launched an open-label extension study, which could support long-term safety and efficacy data for labeling. An independent DMC will assess the Month 15 primary endpoint in Q4 2026; if successful, sub-study results are expected in Q1 2027. If not, the trial continues to the Month 24 analysis, with completion expected in Q3 2027. This follows the recent completion of enrollment in ARCHER II and positive early data from the FORWARD study, building momentum for the vonaprument program. The strategic trial design and regulatory designations (Fast Track, PRIME) position vonaprument as a potential first-in-class vision-preserving therapy for GA.
At the time of this announcement, ANNX was trading at $5.21 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $874.9M. The 52-week trading range was $2.03 to $7.18. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.