FDA Accepts Achieve Life Sciences, Inc. (ACHV) NDA Application for Cytisinicline in Smoking Cessation

A time earlier, connected November 6, the institution confirmed that the US Food and Drug Administration has accepted its New Drug Application for cytisinicline successful smoking cessation. The FDA has besides granted a Prescription Drug User Fee Act (PDUFA) targeted enactment day of June 20, 2026, for cytisinicline for the attraction of nicotine dependence for smoking cessation.

“The NDA acceptance recognizes years of technological and operational committedness to addressing nicotine dependence arsenic a superior aesculapian condition, successful an denotation that has not seen a caller therapy successful astir 20 years,” said Rick Stewart, Chief Executive Officer of Achieve Life Sciences.

In addition, the institution exited the 3rd 4th with currency and currency equivalents of $48.1 million, arsenic full operating expenses for the 3 months totaled $14.7 million. Nevertheless, the institution posted a nett nonaccomplishment of $14.4 cardinal for the 3 months and $40 cardinal for the archetypal 9 months of the year.

Achieve Life Sciences, Inc. (NASDAQ:ACHV) is simply a specialty pharmaceutical institution focused connected processing and commercializing cytisinicline to dainty nicotine dependence and the planetary smoking and vaping epidemic. The institution has completed Phase 3 studies for smoking cessation and has submitted a caller cause exertion to the FDA for this indication.

While we admit the imaginable of ACHV arsenic an investment, we judge definite AI stocks connection greater upside imaginable and transportation little downside risk. If you're looking for an highly undervalued AI banal that besides stands to payment importantly from Trump-era tariffs and the onshoring trend, spot our escaped study connected the best short-term AI stock.

READ NEXT: 10 Best Mexican Stocks to Invest In and 10 Best Cryptocurrency Stocks to Buy for the Long Term.

Disclosure: None. This nonfiction is primitively published at Insider Monkey.