Achieve Life Sciences Stock Soars After $45M Raise and FDA NDA Acceptance

Company Overview

Achieve Life Sciences Inc (NASDAQ: ACHV) is a late-stage specialty pharmaceutical company headquartered in Bothell, Washington. Founded in 2015, the company focuses on advancing cytisinicline, a selective nicotinic acetylcholine receptor partial agonist, as a treatment for nicotine dependence and smoking cessation in adults.

Corporate Structure and Management

With 11–50 employees, Achieve Life Sciences operates with a team dedicated to clinical development, regulatory affairs, and commercial planning. The executive leadership team comprises:

• Richard Stewart, Chief Executive Officer and co-founder, with prior CEO roles at Renown Pharma and Huxley Pharmaceuticals.
• Craig Donnelly, Chief Operations Officer, overseeing manufacturing, supply chain, CMC operations, and product life-cycle management.
• Mark Oki, Chief Financial Officer since December 2024, previously CFO at Aytu Biopharma and Vivus LLC.
• Dr. Mark Rubinstein, Interim Chief Medical Officer, with over two decades of experience in medical affairs related to nicotine cessation and preventive medicine.

Cytisinicline by Ayush Kumar

Recent Developments and News

• On June 20, 2025, Achieve submitted a New Drug Application (NDA) for cytisinicline to the U.S. Food and Drug Administration. The application was accepted for review in September 2025, with a Prescription Drug User Fee Act (PDUFA) date scheduled for June 20, 2026.
• In June 2025, the company completed a financing round raising approximately $45 million to support cytisinicline’s path to potential FDA approval and to fund operations into the second half of 2026.
• On August 14, 2025, Alyeska Investment Group disclosed beneficial ownership of 4,918,822 shares, representing 9.9% of the outstanding common stock.
• HC Wainwright initiated coverage on October 17, 2025, assigning a Buy rating and a $12 per share price target, referencing positive data from the Phase 3 ORCA-2 and ORCA-3 trials and potential market opportunities.
• Form 8-K filings on September 11 and October 7, 2025 (item 5.02) reported changes in executive officer appointments, indicating adjustments within the senior leadership team.

Financial and Strategic Analysis

As of October 17, 2025, ACHV closed at $4.38 per share, showing a 42.13% increase intraday, with a trading volume of approximately 7.5 million shares. Key financial metrics from Yahoo Finance include:

• Market capitalization of approximately $219 million.
• 52-week trading range of $1.84 to $5.31.
• Trailing twelve-month net loss of $50.4 million, with a diluted EPS of –$1.48.
• Total cash of $55.4 million and a debt-to-equity ratio of 23.9%.
• Levered free cash flow of –$21.8 million over the past year.

Strategically, Achieve’s focus on cytisinicline aims to provide a new FDA-approved pharmacotherapy for smoking cessation, potentially the first in nearly two decades. Positive Phase 3 trial results demonstrated higher abstinence rates and tolerability compared to placebo, and the company’s cash runway supports operations through late 2026, coinciding with key regulatory milestones.

Market Position and Industry Context

The global smoking cessation market has seen limited innovation since the approval of Pfizer’s varenicline in 2006. Cytisinicline's mechanism and safety profile may address tolerability concerns that have impacted varenicline's use. If the FDA approves cytisinicline in mid-2026, it would enter a market marked by rising smoking and vaping rates, alongside a demand for effective and well-tolerated therapies. Analysts estimate peak annual sales potential in the high-hundreds of millions to several billion dollars, subject to pricing and reimbursement conditions.

tl;dr

Achieve Life Sciences’ cytisinicline NDA was accepted in September 2025, with a PDUFA date set for June 20, 2026. The company raised approximately $45 million in June 2025 and holds $55 million in cash to fund operations leading up to the regulatory decision. On October 17, 2025, the stock rose 42% to $4.38 following a Buy rating and $12 target from HC Wainwright. Important upcoming events include the mid-2026 FDA decision and a potential commercial launch of the first new smoking cessation drug in nearly two decades.