SEATTLE and VANCOUVER, British Columbia - Achieve Life Sciences, Inc. (NASDAQ: NASDAQ:ACHV), a pharmaceutical company in the late stages of developing a treatment for nicotine dependence, announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to its drug cytisinicline for nicotine e-cigarette cessation.
Cytisinicline, if approved, would be the first pharmacotherapy specifically for nicotine vaping cessation. With no current FDA-approved medications for this purpose, the designation is particularly significant given the estimated 13 million nicotine vape users in the United States.
The FDA's decision comes in the wake of the Phase 2 ORCA-V1 trial results, which were published in the Journal of the American Medical Association (JAMA) Internal Medicine. The trial compared cytisinicline to a placebo in 160 adult e-cigarette users who wished to quit. The study showed that those treated with cytisinicline were 2.6 times more likely to quit vaping than those who received a placebo.
Achieve intends to hold an End-of-Phase 2 meeting with the FDA's multidisciplinary team before the end of the year to discuss the next steps under this designation. The concern over long-term e-cigarette use is growing due to potential serious respiratory and cardiovascular risks, as well as the effects on brain development in adolescents and young adults, which increases the urgency for treatments like cytisinicline.
The Phase 2 ORCA-V1 trial was partially funded by a grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). While cytisinicline shows promise, it is important to note that it remains an investigational product and has not yet been approved by the FDA for any indication in the United States.
Achieve Life Sciences is making significant strides in its ongoing projects. The biopharmaceutical company recently entered preliminary negotiations with Silicon Valley Bank to refinance its existing term loans, aiming to extend the maturity date to June 1, 2028. This move is part of their strategy to strengthen their financial position.
In the realm of medical research, Achieve Life Sciences has been making progress with its cytisinicline trials. The Phase 2 ORCA-V1 vaping cessation trial data, presented at the Society of General Internal Medicine Annual Meeting, showed promising results, with the treatment significantly increasing the chances of quitting compared to a placebo. The company is now planning to discuss label expansion with the FDA.
The company's stock outlook was recently revised by Oppenheimer, which lowered the price target from $18 to $11 while maintaining an Outperform rating. This followed a slight miss in the company's earnings per share report. Despite this, Oppenheimer remains focused on the company's smoking cessation program, particularly the upcoming ORCA OL study.
During their first quarter 2024 earnings call, Achieve Life Sciences announced reaching an agreement with the FDA on the requirements for the New Drug Application filing for smoking cessation. They have secured financing of up to $124 million for the ORCA-OL trial.
InvestingPro Insights
Achieve Life Sciences, Inc. (NASDAQ: ACHV) has made headlines with its FDA Breakthrough Therapy Designation, a milestone that underscores its potential in the nicotine cessation market. Investors and stakeholders are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Achieve Life Sciences has a market capitalization of approximately $169.3 million. The company's stock price has been volatile, with a year-to-date price total return of 19.66%, reflecting investor optimism amidst the recent developments. Nevertheless, over the last twelve months, the stock has seen a decline of 11.96%.
One of the InvestingPro Tips highlights that Achieve Life Sciences holds more cash than debt on its balance sheet, indicating a solid financial position to support its ongoing clinical trials and potential commercialization efforts. However, analysts have expressed concerns as the company suffers from weak gross profit margins and is not expected to be profitable this year. Additionally, Achieve does not pay a dividend, which is common for companies focused on growth and reinvestment into research and development.
InvestingPro offers additional insights, with 6 more tips available for those interested in a deeper dive into Achieve Life Sciences' financials and stock performance. These tips can be accessed through the dedicated InvestingPro page for Achieve Life Sciences at https://www.investing.com/pro/ACHV, providing valuable information for making informed investment decisions.
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