Alterity Therapeutics Ltd. (NASDAQ: ATHE) says it has received an update from the U.S. Food and Drug Administration (FDA) regarding its Parkinson’s treatment. Shareholders were happy, as the stock more than doubled in Tuesday’s session.
The FDA gave guidance on the development pathway for ATH434 (previously PBT434), the company’s lead compound for the treatment of multiple system atrophy (MSA), a Parkinsonian disorder.
Alterity recently met with the FDA following the successful completion of its Phase 1 clinical trial last year and further data analysis. The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development plan for ATH434, including feedback on the Phase 2 study design.
Ultimately, the company reached an agreement with the FDA on the nonclinical investigations required to support the Phase 2 study. Additionally, the FDA agreed to key aspects of the Phase 2 study design, including the proposed patient population, safety monitoring plan and strategy for evaluating drug exposure during the study.
Currently there are no approved treatments for MSA. As a result, there is no regulatory precedent regarding accepted efficacy endpoints. So, the FDA and Alterity will work together to develop an endpoint that is best suited for the MSA patients to be studied.
Separate from Alterity’s U.S. strategy, the company also is pursuing a regulatory pathway in Europe and Australia.
Alterity stock traded up about 118% to $1.27 on Tuesday, in a 52-week range of $0.28 to $1.63.
The #1 Thing to Do Before You Claim Social Security (Sponsor)
Choosing the right (or wrong) time to claim Social Security can dramatically change your retirement. So, before making one of the biggest decisions of your financial life, it’s a smart idea to get an extra set of eyes on your complete financial situation.
A financial advisor can help you decide the right Social Security option for you and your family. Finding a qualified financial advisor doesn’t have to be hard. SmartAsset’s free tool matches you with up to three financial advisors who serve your area, and you can interview your advisor matches at no cost to decide which one is right for you.
Click here to match with up to 3 financial pros who would be excited to help you optimize your Social Security outcomes.
Have questions about retirement or personal finance? Email us at [email protected]!
By emailing your questions to 24/7 Wall St., you agree to have them published anonymously on a673b.bigscoots-temp.com.
By submitting your story, you understand and agree that we may use your story, or versions of it, in all media and platforms, including via third parties.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
