Achieve Life Sciences completes manufacturing transfer to Adare

Achieve Life Sciences Inc. (NASDAQ: ACHV) announced it has completed the transfer of cytisinicline manufacturing to Adare Pharma Solutions' facility in Vandalia, Ohio. The company has finished analytical method transfer to the U.S.-based manufacturing site and produced its first engineering batch of the smoking cessation drug candidate.

The manufacturing transfer follows issues at Achieve's previous third-party manufacturing facility, which received an Official Action Indicated classification from the FDA following a current Good Manufacturing Practice inspection. The FDA observations related to general manufacturing practices at the facility and were not specific to cytisinicline, according to the company's statement.

"The completion of the analytical transfer and the first batch now in the manufacturing site firmly positions Achieve to meet the goal of manufacturing cytisinicline drug product in the U.S.," said Rick Stewart, Chief Executive Officer of Achieve Life Sciences.

Achieve expects to receive a Complete Response Letter from the FDA on or before its June 20, 2026 Prescription Drug User Fee Act goal date. The company plans to resubmit its New Drug Application naming Adare Pharma Solutions as the manufacturer for commercial supply in the fourth quarter of 2026.

The company maintains its guidance for a potential cytisinicline commercial launch in the first half of 2027, pending FDA approval. Cytisinicline is being developed as a treatment for nicotine dependence for smoking cessation in adults, based on two completed Phase 3 studies.

Tom Sellig, Chief Executive Officer of Adare Pharma Solutions and an Achieve board member since 2023, confirmed the partnership in the company's statement.

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