Achieve Life Sciences Inc (NASDAQ: ACHV) is starting the trading session on a strong note this morning, and for good reason. The company released news surrounding a meeting with the FDA that is proving to be a point of excitement for investors. Today, we’ll talk about:
- The news;
- what we’re seeing from ACHV; and
- what we’ll be watching for ahead.
ACHV Provides Regulatory Update
As mentioned above, Achieve Life Sciences is having a great start to the trading session this morning after the company provided a regulatory update. In a press release issued early this morning, the company announced an update on the cystisine development program. The update comes following a meeting between ACHV and the United States Food and Drug Administration (FDA) on the non-clinical and clinical development plans surrounding the treatment.
In the release, the company said that the meeting has further defined its Phase 3 clinical program and expected New Drug Application (NDA) submission. Based on the recommendations by the FDA surrounding the further characterization of cytisine dosing prior to NDA submission, ACHV said that it plans to conduct a Phase 2b optimization trial in approximately 250 smokers in the United States. In this trial, the company will assess various cytisine dosing schedules with the goal of evaluating overall treatment efficacy, safety, and compliance profiles. Ultimately, the results will be used to further design the company’s Phase 3 program, which it expects to initiate in 2019. In a statement, Rick Stewart, Chairman and CEO at ACHV, had the following to offer:
The successful outcome of our discussions with the FDA has provided us with clarity and direction to better inform our Phase 3 clinical development program and our efforts toward expanding cytisine availability… Smoking is responsible for the deaths of nearly a half a million Americans every year and new treatment options are desperately needed to help those battling nicotine addiction.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Achieve Life Sciences, the news proved to be overwhelmingly positive. After all, the meeting with the FDA further defines the path that the company will need to take in order to achieve approval for cytisine. As a result, the company has what it needs in order to continue forward with clinical development. So, it’s no surprise to see that excited investors are sending the stock upward. Of course our partners at Trade Ideas were the first to alert us to the gains. Currently (6:43), ACHV is trading at $4.20 per share after a gain of $0.59 per share or 16.34% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ACHV. In particular, we’re interested in following the continued development of cytisine as the treatment has yielded promising results in previous trials. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks.
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