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.
Credit Card Companies Are Doing Something Nuts
Credit card companies are at war. The biggest issuers are handing out free rewards and benefits to win the best customers.
It’s possible to find cards paying unlimited 1.5%, 2%, and even more today. That’s free money for qualified borrowers, and the type of thing that would be crazy to pass up. Those rewards can add up to thousands of dollars every year in free money, and include other benefits as well.
We’ve assembled some of the best credit cards for users today. Don’t miss these offers because they won’t be this good forever.
Flywheel Publishing has partnered with CardRatings for our coverage of credit card products. Flywheel Publishing and CardRatings may receive a commission from card issuers.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
