Alterity Therapeutics (ATHE) Stock Rockets On FDA News

Alterity Therapeutics ATHE Stock News

Alterity Therapeutics Ltd (NASDAQ: ATHE) is running for the top in the market this morning, trading on premarket gains of more than 180%. The gains come after the company announced that it received guidance from the FDA. Here’s what’s going on:

Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!

ATHE Stock Rockets On FDA News

In the press release, Alterity Therapeutics said that it received guidance from the FDA surrounding ATH434. ATH434 is the company’s lead compound for the treatment of Multiple System Atrophy, or MSA, which is known as a Parkinsonian disorder.

ATHE said that it met with the FDA recently after successfully completing a Phase 1 clinical trial last year. The goal was to obtain input on the development plan for the drug, including feedback on the design of the Phase 2 study.

The company said that it reached an agreement with the FDA surrounding non-clinical investigative requirements to support the Phase 2 study. The FDA also agreed to key aspects of the Phase 2 study design, including patient population, safety monitoring plan, and strategy for evaluating drug exposure during the study.

In a statement, Dr. David Stamler, CMO at ATHE, had the following to offer:

The FDA clearly recognizes the seriousness of MSA and the need for new treatments to address this devastating Orphan disease. Our pre-IND meeting was very collegial, and I look forward to again collaborating with the Division of Neurology to determine the best development path for ATH434 in the US. With the information obtained from this meeting, we have a clear path forward for conducting our Phase 2 study in MSA.

This News Is Huge

At the end of the day, the news issued by Alterity Therapeutics this morning is huge. The company is likely to move forward with a Phase 2 study soon. However, this isn’t your run of the mill study.

At the moment, there are no approved treatments for MSA. Should all go well, the company may be the first to bring a treatment to market. If this is the case, there is a large target audience with absolutely no competition. As such, this could be a massive win for the company and its investors.

The bottom line is that we may be talking about a blockbuster treatment option. As such, ATHE stock should be on your watchlist.

Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!

Don’t Miss The Next Big Story

Join our free mailing list below to receive real-time news alerts!

Subscribe Today!

* indicates required

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.