ATHE News & Events

Alterity Therapeutics announced it has received regulatory feedback following a Type C meeting with the FDA regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy. This second Type C Meeting builds on Alterity's recent regulatory interactions with the FDA and represents a further step for the planned Phase 3 trial in MSA. Alterity received written feedback supporting its plans related to the chemistry, manufacturing, and control elements of the program. The first Type C meeting, which was announced in March, related to clinical pharmacology and non-clinical development aspects of the program. "Confirming alignment with the FDA on the chemistry and manufacturing of ATH434 represents another critical step toward initiation of our Phase 3 program," said David Stamler, CEO of Alterity. "The FDA endorsed our plans related to the manufacture and testing of ATH434 for use in our Phase 3 trial and ultimately for commercialization, if approved. We continue to advance ATH434 through the necessary steps to initiate our pivotal development program, and we look forward to finalizing our plans with the FDA at an End-of-Phase 2 meeting that remains on track for mid-year 2026."

Alterity Therapeutics announced the presentation of new data analyses from the Phase 2 trial of ATH434, demonstrating clinical efficacy in patients with Multiple System Atrophy. The analysis was delivered in an oral presentation during a Late Breaking Science Session at the American Academy of Neurology annual meeting taking place in Chicago. The presentation, entitled, "ATH434 Demonstrates Disease-Modifying Signal in Multiple System Atrophy Using the MuSyCA Composite Scale," described an analysis from the ATH434-201 Phase 2 clinical trial in MSA utilizing the MSA Combined Outcome Assessment. The MuSyCA is a newly developed scale that includes 11 items from both the UMSARS1 I and UMSARS II with highest standardized effect sizes across four MSA cohorts and is intended to improve detection of disease progression in clinical trials. Assessment of the ATH434-201 trial showed results utilizing MuSyCA. MuSyCA demonstrated sensitivity to disease progression with placebo participants worsening by approximately +9.7 points over 52 weeks, confirming the scale is sensitive to change over the study period. Consistent with prior data, ATH434 slowed disease progression on the MuSyCA assessment with a treatment effect of -1.9 to -4.0 points at Week 52. In contrast, when utilizing a MMRM3 statistical analysis, ATH434 slowed disease progression on the modified UMSARS I versus placebo by -3.1 points at 75 mg and -4.7 points at 50 mg.

Alterity Therapeutics announced the appointment of Ann Cunningham to its Board of Directors as an independent Non-Executive Director, effective 17th April 2026. Cunningham's appointment further strengthens Alterity's Board composition, adding significant global commercial and strategic expertise as the Company transitions toward late-stage development in Multiple System Atrophy.

Alterity Therapeutics announced it has received regulatory feedback following a Type C Meeting with the FDA regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy. The Type C Meeting is part of a multidisciplinary strategy to seek alignment with the FDA on readiness to initiate a Phase 3 pivotal trial in MSA. Alterity received written feedback supporting its plans related to the clinical pharmacology and non-clinical development elements of the program. "This meeting confirms alignment with the FDA in two key disciplines and represents an important step toward initiation of the Phase 3 program," said David Stamler, CEO of Alterity. "In addition, we will also be seeking agreement with the FDA on Chemistry, Manufacturing, and Controls and the Phase 3 trial design. Today's favorable outcome sets the stage for our future discussions, culminating in an End-of-Phase 2 meeting that remains on track for mid-year 2026."