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ASX:ATH

7 stories mentioning ASX:ATHUpdated 23d ago

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Asia

Alterity Therapeutics Enters Underwriting Agreement for Exercise of up to 8.4 Million Listed Options

Alterity Therapeutics (ASX:ATH) entered into an underwriting agreement with MST Financial Services, under which MST Financial agreed to underwrite the exercise of up to a total of 8.4 million unexercised ATHO listed options ahead of their expiry, according to a Monday Australian bourse filing.There are currently 15.9 million listed ATHO options on issue, exercisable at AU$0.50 and due to expire on Tuesday. MST Financial agreed to underwrite any shortfall arising from options not exercised by optionholders before the expiry date, up to a maximum of 8.4 million options. It will subscribe, or procure subscriptions, for a corresponding number of new fully paid ordinary shares in the firm.MST Financial will receive an underwriting fee of 7% of the gross proceeds raised from the exercise of options underwritten by it.The options are expected to raise around AU$4.2 million before costs, and the proceeds are expected to support continued late-stage clinical development of its ATH434 candidate in multiple system atrophy, as well as general working capital.Its shares fell 1% in recent trading on Monday.

ASX:ATH
Asia

Alterity Therapeutics Secures New Patent for Oral Drug Candidate for Neurodegenerative Diseases; Shares Up 7%

Alterity Therapeutics (ASX:ATH) secured a new composition-of-matter patent for ATH434, the company's oral drug candidate, from the United States Patent and Trademark Office, according to a Wednesday filing with the Australian bourse.ATH434 is designed to treat neurodegenerative diseases such as multiple system atrophy, Parkinson's disease and related disorders, the filing said.The new patent, which extends protection for ATH434 to at least 2045, provides composition-of-matter protection for a crystalline structure of the mesylate salt form of the drug and protection for methods for treating neurological conditions using it, per the filing.The company's shares surged past 7% in recent Wednesday trade.

ASX:ATH
Asia

Alterity Therapeutics Receives AU$4 Million Tax Refund From Australian Government

Alterity Therapeutics (ASX:ATH) received a research and development tax refund from the Australian government of about AU$4 million for the fiscal year 2025, according to a Thursday filing with the Australian bourse.The tax incentive provides the company with "important funding" to support the development of its clinical programs, Alterity said.The company's shares gained 2% on market close.

ASX:ATH
Asia

Alterity Therapeutics Reaches US FDA Alignment on Phase Three Trial for Neurodegenerative Disorder Treatment Candidate

Alterity Therapeutics (ASX:ATH) reached agreement with the US Food and Drug Administration (FDA) on the key elements of its phase three registrational trial for ATH434 in multiple system atrophy, a neurodegenerative disorder, following a positive end-of-phase two meeting, according to a Tuesday statement by the company after market hours.The US FDA endorsed the proposed study design, including the patient population, treatment duration, and primary endpoint based on part one of the 11-item unified multiple system atrophy rating scale, as well as the selected dosing regimen of 50 milligram administered twice daily.Secondary endpoints including swallowing function, orthostatic hypotension symptoms, and global clinical severity were deemed appropriate, with agreement on statistical methods and safety database size.This alignment reduces risk in the pivotal phase three trial and strengthens the pathway toward a potential new drug application submission, with ATH434 already holding fast track and orphan drug designations from the FDA for multiple system atrophy, the company said.

ASX:ATH
Asia

Alterity Therapeutics Says Data Presentations Support Phase Three Development for Multiple System Atrophy Treatment Candidate

Alterity Therapeutics (ASX:ATH) said data it presented at three medical conferences support the advancement of its ATH434 treatment candidate for multiple system atrophy into phase three clinical development, according to a Tuesday filing with the Australian bourse.One presentation highlighted new research that shows Alterity's magnetic resonance imaging approach can detect the neurodegenerative disease, which is characterized by failure of the autonomic nervous system and impaired movement, in its earliest stages.Meanwhile, a new analysis of the company's phase two trial showed evidence that supports ATH434's impact on slowing the progression of multiple system atrophy."These data continue to strengthen the evidence that ATH434 has the potential to be the first disease-modifying treatment for [multiple system atrophy], a rare and devastating disease with no approved therapy," said Alterity Therapeutics CEO David Stamler.

ASX:ATH
Asia

Alterity Therapeutics Says Peer-Reviewed Study Validates its Approach to Multiple System Atrophy; Shares Fall 9%

Alterity Therapeutics (ASX:ATH) said findings of a study published in the NeuroImage journal support quantitative susceptibility mapping as an objective imaging biomarker to facilitate the earlier diagnosis of multiple system atrophy (MSA), according to a Monday filing with the Australian bourse.Alterity is advancing its ATH434 lead candidate into a phase three program for multiple system atrophy, a neurodegenerative disease that leads to the failure of the autonomic nervous system and impaired movement.The company said it used quantitative susceptibility mapping in a phase two trial in which ATH434 helped improve diagnostic accuracy and provided "objective evidence of target engagement."The peer-reviewed publication validates the company's approach and "reinforces the role of [quantitative susceptibility mapping] as a biomarker for iron-modulating therapies in MSA," Alterity CEO David Stamler said.The company's shares fell 9% in recent Monday trade.

ASX:ATH
Asia

Alterity Therapeutics Secures US FDA Support for ATH434 Phase Three Program

Alterity Therapeutics (ASX:ATH) said it received positive feedback from a second type C meeting with the US Food and Drug Administration (FDA) on its planned phase three program for drug candidate ATH434, aimed at treating multiple system atrophy (MSA), according to a Monday filing with the Australian bourse.MSA is a progressive neurodegenerative disorder affecting autonomic and motor function with no approved disease-modifying therapies.The US FDA provided supportive written feedback on the program's chemistry, manufacturing, and controls, complementing earlier guidance from a separate type C meeting on clinical pharmacology and non-clinical development, the filing added.

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