Announcement • Jun 22
Achieve Life Sciences Receives Complete Response Letter From FDA For Cytisinicline NDA Achieve Life Sciences, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA’s action date. The FDA identified no deficiencies regarding the clinical efficacy or safety of cytisinicline. The deficiencies cited in the CRL concern Achieve's prior third-party manufacturing facility, which received an Official Action Indicated (OAI) classification from the FDA for general cGMP matters at the facility that are not specific to cytisinicline. Achieve had previously partnered with U.S.-based Adare Pharma Solutions (Adare) as its new primary commercial manufacturing partner. Achieve has completed the analytical method technology transfer to Adare’s facility, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the site. Achieve intends to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner, with potential FDA approval in the first half of 2027, followed by U.S. commercial launch. The cytisinicline NDA is supported by a comprehensive clinical development program with more than 1,500 clinical trial participants exposed to cytisinicline. In the pivotal Phase 3 ORCA-2 and ORCA-3 trials, cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater smoking abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo. Safety data includes over 400 participants who received at least six months of cumulative cytisinicline exposure and over 200 participants who received at least one year of cumulative exposure. This long-term safety data was previously reported and presented at the American Thoracic Society (ATS) International Conference in May 2026. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Announcement • Jun 02
Achieve Life Sciences, Inc. Announces Board Appointments Achieve Life Sciences, Inc. announced that Jeffrey Farrow and Reid Waldman, MD have been appointed to its Board of Directors. Mr. Farrow currently serves as Chief Financial Officer and Chief Strategy Officer of Tarsus Pharmaceuticals, Inc., where he has helped guide the ongoing commercial launch of XDEMVY (lotilaner ophthalmic solution) 0.25% for Demodex blepharitis. Dr. Waldman is the Founder and Chief Executive Officer of Veradermics, Incorporated. Jeffrey Farrow has served as Chief Financial Officer and Chief Strategy Officer of Tarsus Pharmaceuticals, Inc. since April 2023, where he has helped lead the ongoing commercial launch of XDEMVY for Demodex blepharitis. Mr. Farrow has been Chief Financial Officer of four publicly traded biopharmaceutical companies, including three that were acquired for total transaction value of more than $9 billion. He previously served as Chief Financial Officer of Global Blood Therapeutics, Inc. from April 2016 until its acquisition by Pfizer for approximately $5.4 billion in December 2022, during which time the Company received FDA approval and commercially launched Oxbryta for sickle cell disease. Prior to that, he served as Chief Financial Officer of ZS Pharma, Inc., acquired by AstraZeneca for approximately $2.7 billion in December 2015, and Chief Financial Officer of Hyperion Therapeutics, Inc. from January 2010 until its acquisition by Horizon Therapeutics for approximately $1.1 billion in May 2015, where he was part of the team that secured FDA approval and commercially launched RAVICTI® for urea cycle disorders. Earlier in his career, he held senior finance roles at Evotec AG and Renovis, Inc. (acquired by Evotec), and spent seven years in the audit practice of KPMG LLP. Mr. Farrow holds a B.A. in business administration with a concentration in corporate finance from California State University at Fullerton and is a certified public accountant (inactive). He currently serves on the Board of Directors of Clover Biopharmaceuticals Ltd. and California Life Sciences (CLS). Dr. Waldman is the Chief Executive Officer of Veradermics. Under his stewardship, he has positioned Veradermics for rapid growth by implementing a differentiated strategy centered on advancing therapeutics for under-innovated markets in aesthetics and dermatology. He has also successfully led the company through significant equity financings, and has advanced Veradermics’ lead asset, VDPHL01, a potential non-hormonal oral treatment for pattern hair loss, through positive Phase 2/3 results for men. Dr. Waldman is a board-certified dermatologist with more than 10 years of clinical experience. Prior to founding Veradermics, Dr. Waldman was a prolific researcher authoring more than 100 publications, including a textbook titled “Dermatology for the Primary Care Provider.” He has been the recipient of numerous accolades including the American Academy of Dermatology’s “Excellence in Patient Care” award. He earned his BA and his MD degrees from the University of Missouri–Kansas City 6-Year BA/MD Program and completed his dermatology residency with a “Distinction in Clinical Trials” at the University of Connecticut. 
