Achieve Life Sciences, Inc

Achieve Life Sciences plans to sell up to $50M in stock, with Jefferies as the sales agent. Shares dropped 3.6% in after-hours trading following a 7.4% gain earlier. The proceeds will fund the development of cytisinicline, a plant-based alkaloid for vaping addiction, which received FDA's 'breakthrough therapy' designation. Additional safety data request may delay approval until 2026. Achieve also announced a leadership change, with Richard Stewart replacing John Bencich as CEO.

5 in 6 Americans who tried to quit smoking in 2022 failed, highlighting ineffective treatments and lack of innovation. Despite the addiction killing 480,000 annually, no new class of drugs has been approved in nearly two decades. Drugmakers and the FDA are criticized for lackadaisical approaches and stringent approval standards, focusing more on profitable drugs for rare cancers. Advocates call for a 'Reduce to Quit' approach and more flexible FDA standards to address the public health crisis.