Achieve Life Sciences’ Smoking Treatment Likely To Be Approved By FDA, Says Hunterbrook

Hunterbrook Capital on Tuesday revealed it is long on Achieve Life Sciences (ACHV) stock as the company nears a green light from the U.S. Food and Drug Administration for Cytisinicline as a treatment for smoking addiction.

The FDA is expected to rule on Achieve Life Sciences’ application seeking approval for the drug by June 20, 2026. If approved, the company plans to sell it in the U.S. by the end of the year.

Hunterbrook Media said that Cytisinicline is already used in Europe and added that smoking cessation clinicians, scientists, and health program directors that it interviewed recommended approval in the U.S.

The report also noted that Cytisinicline has proven safer and more effective than its predecessors including Pfizer’s Chantix and GlaxoSmithKline’s Zyban. Chantix, despite side effects, earned over $1 billion in peak annual sales and it, like GSK’s Zyban, also required longer treatment than Cytisinicline, the firm said.

Furthermore, despite smoking being on the decline, it is still rampant, the firm noted.

There are about 29 million American cigarette smokers and about 28 million e-cigarette users, including many middle and high schoolers, the firm said. While about a half of this population try to quit, only a small portion succeeds.

FDA Priority Review Voucher

The FDA awarded Achieve a Commissioner's National Priority Voucher (CNPV) aimed at expediting review for Cytisinicline in October. “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 then.

Hunterbrook Flags Potential Headwinds

“As with all applications, the FDA could still require additional data or studies if any safety concerns arise. Achieve also needs to maintain long-term access to cytisinicline supply.  The company is in a legal dispute with its original supplier, Sopharma, though Achieve named other suppliers in its FDA application,” Hunterbrook said.

The firm also flagged funding concerns, highlighting that while Achieve is funded through the second quarter of 2026, it will need to raise more capital to commercialize the drug after receiving approval.

How Did Stocktwits Users React?

ACHV stock traded 7% higher at the time of writing. On Stocktwits, retail sentiment around ACHV jumped from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to 'normal' levels.

ACHV stock has gained 34% this year and by about 31% over the past 12 months. 

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