Alterity Therapeutics reported that official FDA End-of-Phase 2 meeting minutes for ATH434 in Multiple System Atrophy confirm the planned registrational Phase 3 program and a clear path toward a potential New Drug Application. The FDA agreed that a single pivotal Phase 3 trial, supported by confirmatory evidence, could support approval of ATH434 for MSA.
The Phase 3 study is expected to enroll about 200 patients, randomized 1:1 to ATH434 50 mg or placebo twice daily for 12 months, with the 11‑item UMSARS Part I as the primary endpoint and several functional secondary endpoints. Trial activities are described as on track to start by year-end 2026, with an open-label extension planned and Phase 2 data intended to serve as confirmatory evidence.
ALTERITY THERAPEUTICS LTD director Julian Michael Babarczy, through Vaucluse Investment Holdings Pty Ltd <Jigsaw Investment A/C>, received a grant of unlisted options on June 15, 2026. The award covers 2,000,000 options, each exercisable into one ordinary share at an exercise price of 1.0000 per share, expiring on June 15, 2031. This is a compensation-related acquisition of derivative securities, not an open-market share purchase or sale, and leaves 2,000,000 options held indirectly following the transaction.
ALTERITY THERAPEUTICS LTD director Lawrence Bernard Gozlan, through Montoya Pty Ltd <Buttercup A/C>, received a grant of derivative securities. The award consists of 1,000,000 listed options, each exercisable into one ordinary share at an exercise price of $1.0000 per share.
The options were granted on 15 June 2026 and expire on 15 June 2031. Following this grant, the indirect holdings reported in this listed option position total 1,000,000 options.
Alterity Therapeutics has completed a consolidation of its issued capital on a fifty (50) to one (1) basis, as previously approved by shareholders. After the consolidation, the company has 217,508,862 ordinary fully paid shares on issue, along with multiple listed and unlisted option series with various expiries and exercise prices.
The company confirms post-consolidation holdings for shareholders and option holders, with any fractional entitlements rounded up to the nearest whole security. Normal T+2 trading in the consolidated shares has commenced on the ASX under code ATH. Alterity remains a clinical-stage biotechnology company focused on Multiple System Atrophy, preparing to initiate a Phase 3 pivotal trial for its lead asset ATH434.