Alterity Therapeutics Ltd Stock Price, News & Analysis

Alterity Therapeutics (NASDAQ: ATHE) announced multiple presentations at the 2025 International MSA Congress in Boston, highlighting their clinical programs in Multiple System Atrophy (MSA). The company will present Phase 2 data for ATH434, their lead candidate that recently received Fast Track Designation from the FDA. Dr. David Stamler, CEO, will deliver a plenary presentation on how "ATH434 Slowed Disease Progression in Phase 2 Study." The congress will also feature research from Vanderbilt University Medical Center collaborators on MSA biomarkers. ATH434 is an oral agent designed to inhibit pathological protein aggregation in neurodegeneration by restoring brain iron balance. The drug has shown positive results in Phase 2 trials, demonstrating clinical efficacy, target engagement, and favorable safety. ATH434 has received both FDA and European Commission Orphan Drug Designation for MSA treatment.

Alterity Therapeutics (NASDAQ: ATHE) has received Fast Track designation from the FDA for its drug candidate ATH434 in treating Multiple System Atrophy (MSA). This designation, complementing their existing Orphan Drug Designation, aims to accelerate the development and review process for ATH434, recognizing its potential as an innovative treatment for MSA - a condition currently without approved therapies.

CEO David Stamler highlighted that the Fast Track status validates ATH434's promise, supported by recent scientific findings on its mechanism of action and positive results from their double-blind Phase 2 clinical trial. The designation enables more frequent FDA interactions, potentially expediting the drug's development and approval pathway.

Alterity Therapeutics reported positive results from its ATH434-201 Phase 2 clinical trial for Multiple System Atrophy (MSA) treatment. The trial demonstrated a significant 48% reduction in disease severity at 50mg dose and 30% at 75mg dose compared to placebo.

Key financial highlights include a cash balance of A$17.96M as of March 31, 2025, with an additional A$27.1M raised after the quarter end. Operating cash outflows were A$0.73M for Q3 FY25.

The company completed its ATH434-202 open-label trial in advanced MSA patients in March 2025, with topline data expected mid-year. The drug showed positive results in clinical efficacy, including improvements in daily living activities, severity assessment, and increased patient activity levels measured by wearable sensors. ATH434 was well-tolerated with no serious adverse events attributed to the treatment.

Alterity Therapeutics (NASDAQ: ATHE) presented Phase 2 clinical trial results for ATH434-201 at the MSA Research Symposium. The double-blind study, involving 71 patients, demonstrated significant efficacy in treating Multiple System Atrophy (MSA).

Key findings include:

• 48% relative treatment effect at 50mg dose (p=0.02) and 30% at 75mg dose (p=0.16) on UMSARS I scale
• Improvement in Clinical Global Impression of Severity Scale at both doses
• Enhanced patient mobility metrics including step count and walking time
• Positive results in reducing brain atrophy and stabilizing iron levels in affected brain regions

The treatment was well-tolerated with similar adverse event rates to placebo, with no serious adverse events attributed to ATH434. The strong clinical efficacy data and novel mechanism support continued advancement of ATH434 for MSA treatment.

Alterity Therapeutics (NASDAQ: ATHE) has presented new data from its ATH434 Phase 2 trial for Multiple System Atrophy (MSA) at the American Academy of Neurology 2025 Annual Meeting. The double-blind study showed promising results with clinically meaningful efficacy across multiple measures.

Key findings include:

• 48% decrease in clinical progression at 50mg dose (p=0.02) and 30% decrease at 75mg dose using modified UMSARS I rating scale
• Improvement in Clinical Global Impression of Severity Scale at 50mg dose (p=0.0088)
• Positive trends in Orthostatic Hypotension Symptom Assessment
• Increased activity levels measured by wearable sensors, including improved step count, walking time, and standing time

The imaging outcomes in 61 participants demonstrated that ATH434 reduces iron signal in MSA-affected brain regions. Additionally, results from the bioMUSE natural history study supported the utility of wearable sensors in MSA trials, showing correlations between sensor-derived metrics and clinical evaluations.

Alterity Therapeutics (NASDAQ: ATHE) has announced upcoming presentations of its ATH434 Phase 2 clinical trial results for Multiple System Atrophy (MSA) at the American Academy of Neurology Annual Meeting in San Diego (April 5-9, 2025).

The presentations include an oral session featuring topline data from the randomized, double-blind, placebo-controlled Phase 2 study, to be presented by Dr. Daniel Claassen from Vanderbilt University Medical Center. Additionally, a poster presentation will discuss wearable sensor data correlation with clinical scores in early-stage MSA patients.

ATH434 is an oral agent designed to inhibit pathological protein aggregation in neurodegeneration by restoring brain iron balance. The drug has received Orphan Drug Designation for MSA treatment from both the FDA and European Commission. Besides the completed Phase 2 trial showing positive results, a second Phase 2 open-label biomarker trial in advanced MSA patients is currently ongoing.

Alterity Therapeutics (NASDAQ: ATHE) has announced the completion of the last patient visit in its ATH434-202 Phase 2 open-label trial for Multiple System Atrophy (MSA). The study aims to evaluate the safety, efficacy, and target engagement of ATH434, a disease-modifying drug candidate for neurodegenerative diseases, specifically in patients with advanced MSA.

Following positive results from their previous randomized, double-blind Phase 2 trial, this open-label study focuses on a population with advanced-stage illness. The company expects to report topline data by mid-year 2025. CEO David Stamler emphasized that the data will help guide their development program, noting the differences between this study and the double-blind trial.

Alterity Therapeutics (NASDAQ: ATHE) has secured binding commitments for a A$40.0 million capital raise through a two-tranche placement of ordinary shares to institutional and sophisticated investors. The placement was conducted at A$0.011 per share, an 8.3% discount to the last closing price, with one free attaching option for every three new shares issued.

The funding will primarily support the advancement of ATH434, their lead compound for neurodegenerative diseases, which recently showed significant results in Multiple System Atrophy (MSA) treatment. The Phase 2 clinical trial demonstrated a 48% slowing of clinical progression at the 50mg dose and favorable safety profile.

The placement consists of a A$12.8 million Tranche One (1.2 billion shares) and a A$27.2 million Tranche Two (2.5 billion shares), with the latter requiring shareholder approval at an Extraordinary General Meeting expected in March 2025.

Alterity Therapeutics announced positive topline results from their ATH434-201 Phase 2 clinical trial for treating early-stage multiple system atrophy (MSA). The trial demonstrated significant clinical benefits, with the 50mg dose showing a 48% slowing of clinical progression (p=0.03) and the 75mg dose showing a 29% slowing at Week 52 compared to placebo.

Key findings include:

• Reduced iron accumulation in MSA-affected brain regions
• Trends in preservation of brain volume
• Improved motor performance on the Parkinson's Plus rating scale
• Favorable safety profile with no serious adverse events related to ATH434

The study enrolled 77 adults across 23 sites in six countries, with participants randomly assigned to receive either 50mg, 75mg, or placebo. The 50mg dose demonstrated the most promising results, showing statistically significant improvement on the modified UMSARS Part I, a key clinical endpoint for FDA approval.