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

Achieve Life Sciences Inc. (NASDAQ:ACHV) is one of the Canadian penny stocks to buy right now. Lake Street’s Thomas Flaten maintained a Buy rating on Achieve Life Sciences Inc. (NASDAQ:ACHV) at $11.00 on November 7.

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

A day earlier, on November 6, the company confirmed that the US Food and Drug Administration has accepted its New Drug Application for cytisinicline in smoking cessation. The FDA has also granted a Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026, for cytisinicline for the treatment of nicotine dependence for smoking cessation.

“The NDA acceptance recognizes years of scientific and operational commitment to addressing nicotine dependence as a serious medical condition, in an indication that has not seen a new therapy in nearly 20 years,” said Rick Stewart, Chief Executive Officer of Achieve Life Sciences.

In addition, the company exited the third quarter with cash and cash equivalents of $48.1 million, as total operating expenses for the three months totaled $14.7 million. Nevertheless, the company posted a net loss of $14.4 million for the three months and $40 million for the first nine months of the year.

Achieve Life Sciences, Inc. (NASDAQ:ACHV) is a specialty pharmaceutical company focused on developing and commercializing cytisinicline to treat nicotine dependence and the global smoking and vaping epidemic. The company has completed Phase 3 studies for smoking cessation and has submitted a new drug application to the FDA for this indication.

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Disclosure: None. This article is originally published at Insider Monkey.