The program, announced in June, aims to reduce the time taken for FDA assessments from the standard 10 to 12 months to one to two months.
Shares of Achieve Life Sciences, Inc. (ACHV) soared 32% on Friday afternoon after the company said that the U.S. Food and Drug Administration (FDA) awarded the company a Commissioner’s National Priority Voucher (CNPV) for its Cytisinicline.
The voucher is only available to nine programs in the program’s inaugural year. The program, announced in June, aims to reduce FDA assessment times to one to two months from the standard 10 to 12 months.
Achieve Life Sciences’ Cytisinicline is indicated for nicotine e-cigarette or vaping cessation. “It’s been nearly two decades since a new treatment option for smoking cessation was approved, and there are currently no treatment options for vaping cessation,” Achieve CEO Rick Stewart said.
In a mid-stage trial, participants treated with Cytisinicline were found to be 2.6 times more likely to quit using nicotine e-cigarettes or vapes compared to placebo. The FDA has agreed on a late-stage trial design that, together with the mid-stage data, would support an application for approval in vaping cessation.
In September, the FDA accepted the company’s application for Cytisinicline as a treatment for smoking cessation. The agency is expected to decide on the application by June 20, 2026.
On Stocktwits, retail sentiment around ACHV stock jumped from ‘neutral’ to ‘extremely bullish’ territory while message volume rose from ‘low’ to ‘extremely high’ levels.
Other drugs awarded the voucher under the FDA program include Merck Group’s infertility treatment Pergoveris, Sanofi’s Type 1 diabetes therapy Teplizumab, Regeneron’s gene therapy DB-OTO for congenital deafness, and more.
ACHV stock is up by 15% this year and down by about 20% over the past 12 months.
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