New CEO at Achieve Life Sciences as Cytisinicline NDA Nears Decision

Achieve Life Sciences has appointed Andrew D. Goldberg, MD, as Chief Executive Officer and board member, effective upon the closing of a recently announced financing round of up to $354 million ($180 million upfront, with $174 million contingent on milestone warrant exercises). The leadership transition comes as the company positions for a potential FDA approval of cytisinicline, which would be the first new treatment for nicotine dependence in approximately two decades. For regulatory affairs professionals tracking NDA timelines in the smoking cessation space, the move signals a deliberate shift from development-stage leadership to a commercially oriented executive team.

Goldberg replaces Richard Stewart, the outgoing President, CEO, and co-founder, who will remain on the board. Stewart oversaw the advancement of cytisinicline toward a potential FDA submission. Thomas King, chairman of Achieve's board, noted that Goldberg's "clinical experience as a practicing physician, combined with his proven track record in healthcare investment and commercial strategy" were central to the appointment. Goldberg is a dual board-certified physician whose career has spanned clinical practice in intensive care and emergency medicine, healthcare investment roles at Marshall Wace and Vivo Capital, and management consulting at McKinsey & Company. Notably, he served as a board director at Tarsus Pharmaceuticals through FDA approval and the national launch of XDEMVY, and at Elektrofi through its $900 million acquisition by Halozyme Therapeutics.

Alongside the CEO appointment, Achieve named two new board members, both effective upon closing of the financing: Lucian Iancovici, MD, a Managing Director at TPG with experience in emerging life sciences companies, and Aaron E. Royston, MD, a Managing Partner at venBio with more than 15 years in life sciences investing, company formation, and clinical research. The reconstituted board and fresh capital infusion together suggest the company is building the governance and financial infrastructure needed for a potential commercial launch.

Goldberg, in a statement, described cytisinicline as a "generational public health opportunity" to address both smoking and the rise of vaping. While the characterization is the incoming CEO's own, the underlying regulatory and commercial stakes are clear: if approved, cytisinicline would enter a treatment category that has seen no new entrants in roughly 20 years. Plant-level and quality operations leaders at contract manufacturers and prospective commercial partners should note that the financing and leadership changes indicate Achieve is actively preparing for scale-up and launch activities, pending regulatory outcome.

Source: Achieve Life Sciences press release, April 16, 2026, via GlobeNewswire.