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Smoking Cessation Drug Could Be First FDA Approval in Two Decades

MarketDash Editorial Team
3 hours ago
Achieve Life Sciences' cytisinicline shows promise as potentially the best therapy for quitting smoking, with experts backing FDA approval and a clearer safety profile than previous market leaders like Chantix.

Here's something you don't see every day: a new smoking cessation drug that might actually work better than what we've had for the past two decades. On Tuesday, Hunterbrook Media published an extensive report on Achieve Life Sciences Inc. (ACHV), a roughly $250 million medical company that submitted a New Drug Application to the FDA in June 2025 for cytisinicline, a treatment for nicotine dependence in adults trying to quit smoking.

If approved, cytisinicline would mark the first FDA-approved smoking cessation therapy in nearly 20 years, with a potential U.S. launch in 2026. According to the Hunterbrook report, cytisinicline is "likely the best therapy to quit smoking." That's quite a claim, but the evidence appears to back it up.

The FDA Timeline and Priority Status

The FDA accepted the cytisinicline New Drug Application in September, setting a PDUFA target action date of June 20, 2026. Adding weight to the application, cytisinicline is included under the FDA's new Commissioner's National Priority Voucher program for nicotine vaping addiction, a designation that signals the agency's recognition of the public health urgency.

Here's where things get interesting from a market access perspective: under the Affordable Care Act, most U.S. health plans are required to cover FDA-approved smoking cessation therapies. That means if cytisinicline gets the green light, it won't face the usual reimbursement battles that plague many new drugs. The pathway is already there.

Better Than What Came Before

Cytisinicline isn't some untested experimental compound. It's already widely used in Europe, giving researchers plenty of real-world data to work with. Multiple smoking cessation clinicians, researchers, and public health leaders interviewed by Hunterbrook said the drug warrants FDA approval, and notably, none called for additional clinical data. That kind of consensus is rare.

The drug has demonstrated a more favorable safety and efficacy profile than prior U.S. market leaders. Take Pfizer Inc. (PFE) Chantix (varenicline), which generated more than $1 billion in annual sales before being withdrawn from the market. Or GSK Plc (GSK) Zyban (bupropion), which also exited branded markets but remains available in generic form.

The safety comparison is particularly striking. Chantix carried a suicidality warning and showed roughly four times higher nausea rates than cytisinicline, along with more sleep disturbances and headaches. While the FDA later removed the suicidality warning from Chantix after further data emerged, cytisinicline has not shown the risk of suicidal ideation at all.

Expert Endorsement

Dr. Robert West of University College London told Hunterbrook that the FDA "definitely should" approve cytisinicline. In his written statement to Hunterbrook, West explained: "From the available evidence, cytisinicline has the potential to be at least as effective as varenicline when given using an appropriate dosing regimen and is almost certainly more effective than bupropion."

That's a measured but clear endorsement from someone who knows the field inside and out. When experts stop hedging and start saying "definitely should," it's worth paying attention.

Market Reaction

Investors seemed to appreciate the Hunterbrook report. Achieve Life Sciences (ACHV) shares were up 7.42% at $4.76 at the time of publication on Tuesday, according to market data. For a $250 million company potentially sitting on the first new FDA-approved smoking cessation drug in two decades, that's just the beginning of the story. The real question is whether the FDA agrees with the experts when June 2026 rolls around.

Back to Stock Market News

Smoking Cessation Drug Could Be First FDA Approval in Two Decades

MarketDash Editorial Team
3 hours ago
Achieve Life Sciences' cytisinicline shows promise as potentially the best therapy for quitting smoking, with experts backing FDA approval and a clearer safety profile than previous market leaders like Chantix.

Here's something you don't see every day: a new smoking cessation drug that might actually work better than what we've had for the past two decades. On Tuesday, Hunterbrook Media published an extensive report on Achieve Life Sciences Inc. (ACHV), a roughly $250 million medical company that submitted a New Drug Application to the FDA in June 2025 for cytisinicline, a treatment for nicotine dependence in adults trying to quit smoking.

If approved, cytisinicline would mark the first FDA-approved smoking cessation therapy in nearly 20 years, with a potential U.S. launch in 2026. According to the Hunterbrook report, cytisinicline is "likely the best therapy to quit smoking." That's quite a claim, but the evidence appears to back it up.

The FDA Timeline and Priority Status

The FDA accepted the cytisinicline New Drug Application in September, setting a PDUFA target action date of June 20, 2026. Adding weight to the application, cytisinicline is included under the FDA's new Commissioner's National Priority Voucher program for nicotine vaping addiction, a designation that signals the agency's recognition of the public health urgency.

Here's where things get interesting from a market access perspective: under the Affordable Care Act, most U.S. health plans are required to cover FDA-approved smoking cessation therapies. That means if cytisinicline gets the green light, it won't face the usual reimbursement battles that plague many new drugs. The pathway is already there.

Better Than What Came Before

Cytisinicline isn't some untested experimental compound. It's already widely used in Europe, giving researchers plenty of real-world data to work with. Multiple smoking cessation clinicians, researchers, and public health leaders interviewed by Hunterbrook said the drug warrants FDA approval, and notably, none called for additional clinical data. That kind of consensus is rare.

The drug has demonstrated a more favorable safety and efficacy profile than prior U.S. market leaders. Take Pfizer Inc. (PFE) Chantix (varenicline), which generated more than $1 billion in annual sales before being withdrawn from the market. Or GSK Plc (GSK) Zyban (bupropion), which also exited branded markets but remains available in generic form.

The safety comparison is particularly striking. Chantix carried a suicidality warning and showed roughly four times higher nausea rates than cytisinicline, along with more sleep disturbances and headaches. While the FDA later removed the suicidality warning from Chantix after further data emerged, cytisinicline has not shown the risk of suicidal ideation at all.

Expert Endorsement

Dr. Robert West of University College London told Hunterbrook that the FDA "definitely should" approve cytisinicline. In his written statement to Hunterbrook, West explained: "From the available evidence, cytisinicline has the potential to be at least as effective as varenicline when given using an appropriate dosing regimen and is almost certainly more effective than bupropion."

That's a measured but clear endorsement from someone who knows the field inside and out. When experts stop hedging and start saying "definitely should," it's worth paying attention.

Market Reaction

Investors seemed to appreciate the Hunterbrook report. Achieve Life Sciences (ACHV) shares were up 7.42% at $4.76 at the time of publication on Tuesday, according to market data. For a $250 million company potentially sitting on the first new FDA-approved smoking cessation drug in two decades, that's just the beginning of the story. The real question is whether the FDA agrees with the experts when June 2026 rolls around.

    Smoking Cessation Drug Could Be First FDA Approval in Two Decades - MarketDash News