Shares of Achieve Life Sciences (NASDAQ:ACHV) jumped 22.7% in premarket trading Friday after the company revealed it has been awarded a Commissioner’s National Priority Voucher (CNPV) by the U.S. Food and Drug Administration (FDA) for its cytisinicline therapy, aimed at helping people quit e-cigarettes and vaping.
The CNPV designation is a rare achievement, granted to only nine therapies during the program’s first year. It will speed up the FDA review timeline for cytisinicline dramatically, cutting the typical 10–12 month evaluation period to just one to two months once the final submission is made.
Cytisinicline is being developed as a first-in-class therapy designed specifically for e-cigarette and vaping cessation. The treatment targets an estimated 17 million adult e-cigarette users in the U.S., with around 60% reportedly seeking to quit.
“Achieve is redefining the future of nicotine dependence,” said Rick Stewart, Chief Executive Officer of Achieve. “This voucher accelerates our path to potentially pioneering the first and only FDA-approved treatment of nicotine dependence for e-cigarette or vaping cessation, which would establish an entirely new category to serve the millions of people who want to quit vaping.”
In the company’s Phase 2 ORCA-V1 trial, participants receiving cytisinicline were found to be 2.6 times more likely to quit using nicotine e-cigarettes than those given placebo. The FDA has also granted cytisinicline Breakthrough Therapy designation for e-cigarette cessation.
In a separate update, Achieve announced that the FDA has accepted its New Drug Application for cytisinicline as a smoking cessation treatment, with a target action date of June 20, 2026.
Achieve Life Sciences stock price
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