Achieve Life Sciences Inc. (NASDAQ:ACHV) shares are up during Thursday's premarket session. Year to date, the stock has fallen around 43%.
Achieve Life Sciences Partners For US Manufacturing
On Tuesday, the company announced a partnership with U.S.-based Adare Pharma Solutions for the manufacturing of cytisinicline.
Achieve Life Sciences selected Adare Pharma Solutions to manufacture its cytisinicline drug product to address nicotine dependence.
The partnership is expected to reduce risks associated with international importation and potentially lower costs, including tariffs, as Achieve progresses toward a commercial launch anticipated in the first half of 2027.
Achieve commenced the technology transfer to Adare.
Additionally, Achieve's financial results for the fourth quarter and full year 2025 revealed a total net loss of $14.7 million for the quarter and $54.7 million for the year, with cash and marketable securities totaling $36.4 million as of December 31, 2025.
The company is committed to advancing cytisinicline as a treatment option for nicotine addiction, with ongoing clinical trials and a focus on a data-driven commercial launch strategy.
Achieve Life Sciences Shifts Launch
The company also reported that the U.S. Food and Drug Administration recently inspected one manufacturer named in the cytisinicline application and identified two observations related to solid oral dose manufacturing.
The company said it is addressing the observations and anticipates a U.S. commercial launch in the first half of 2027, compared with its earlier expectation of 2026.
Rick Stewart, President and Chief Executive Officer of Achieve, said, "Establishing U.S. manufacturing with Adare increases our confidence in our supply chain and continues our strong progress towards launch."
Clinical Data Support Cytisinicline Potential
In March, Achieve Life Sciences shared new data showing that 6 and 12 weeks of cytisinicline deliver meaningful quitting success, regardless of participants' prior use of smoking cessation medications or number of previous quit attempts.
As per a long report released in December 2025, Cytisinicline could become the first FDA-approved smoking cessation therapy in nearly 20 years.
According to the Hunterbrook report, cytisinicline is ‘likely the best therapy to quit smoking.'
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ACHV Stock Price Activity: Achieve Life Sciences shares were up 0.13% at $2.824 during premarket trading on Thursday, according to Benzinga Pro data.
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