Achieve Life Sciences Fourth Quarter Results Meet Expectations

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Seattle - Achieve Life Sciences Inc. (NASDAQ: ACHV) announced its fourth-quarter results in line with analyst expectations, reporting a loss of $0.28 per share, matching the market consensus of a $0.28 loss per share.

Following the earnings release, the company’s stock remained unchanged in pre-market trading.

This late-stage pharmaceutical company, focused on developing cytisine-based nicotine for nicotine dependence treatment, reported a net loss of $14.7 million for the three months ending December 31, 2025, compared to a net loss of $12.4 million in the same period last year. For the full year 2025, the company’s net loss was $54.6 million. Total operating expenses for the fourth quarter were $14.7 million, up from $12.2 million in the same quarter last year.

The company announced a new manufacturing partnership with U.S.-based Adare Pharma Solutions to produce cytisine nicotine drugs, aiming to reduce costs and mitigate risks associated with international drug imports, including potential tariffs.

Achieve has begun technology transfer to Adare and expects to commercialize the product in the U.S. in the first half of 2027.

President and CEO Rick Stewart stated, “Achieve is fully committed to bringing cytisine nicotine to the millions still struggling with nicotine dependence and in need of new solutions to help them quit smoking.”

The company reported progress in regulatory approval, with the FDA accepting its new drug application for cytisine nicotine and setting a PDUFA target action date of June 20, 2026.

Achieve completed its ORCA-OL long-term exposure trial, with 334 participants completing a one-year study. Additionally, cytisine nicotine was selected as one of nine e-cigarette or vapor cigarette cessation therapies for the FDA Commissioner’s National Priority Review Voucher.

As of December 31, 2025, Achieve held $36.4 million in cash, cash equivalents, and marketable securities.

This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.

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