AchieveRx Keeps Cytisinicline NDA Resubmission on Track

The Tip Desk · November 12, 2026 · 4 min read

Cash, cash equivalents and marketable securities stood at $201.5 million as of September 30, 2026, up from $187.3 million at June 30.

Achieve Life Sciences, Inc. (QUIT), now doing business as AchieveRx, The Quit Company, completed three commercial-scale stability batches at U.S. manufacturer Adare Pharma Solutions and kept its New Drug Application resubmission on track for the fourth quarter of 2026.

The late-stage pharmaceutical company, focused on cytisinicline as a treatment for nicotine dependence, said it anticipates potential FDA approval by the end of the second quarter of 2027, with U.S. commercial launch to follow if approved. That timing is consistent with the first half of 2027 it had cited in the second-quarter update.

In October, AchieveRx presented 52-week results from the long-term, open-label ORCA-OL trial of cytisinicline 3 mg three times daily at the CHEST 2026 Annual Meeting. The study enrolled 479 adults who were still smoking and/or vaping after a counseling-supported quit attempt in a prior ORCA trial; those who smoked had made a median of five quit attempts. Quit rates (four-week continuous abstinence) rose over the course of treatment, from 25.5% at Weeks 9–12 to 31.2% at Weeks 49–52. At the end of treatment, 39.4% of participants new to cytisinicline had quit, as had 27.8% of those who had taken cytisinicline in a prior trial and were still smoking or vaping. The company said cytisinicline was generally well tolerated over the 52 weeks and that the independent Data Safety Monitoring Committee identified no new safety signals.

The manufacturing step closed the quarter’s regulatory thread. After the June Complete Response Letter tied to cGMP observations at a prior third-party facility and incomplete labeling, AchieveRx said it continued the transition of finished drug product manufacturing to Adare and completed three commercial-scale stability batches there. Resubmission of the NDA remains on track for the fourth quarter of 2026.

On November 9, 2026, Achieve Life Sciences, Inc. began trading under the Nasdaq ticker QUIT. Chief Executive Officer Andrew D. Goldberg said the rebrand reflects a shift from a clinical-stage company to one preparing to launch what could be the first new FDA-approved prescription medicine in 20 years to help people who smoke quit.

The company added Ben Halladay as Chief Financial Officer and Kaitlyn Tuson as Senior Vice President, Marketing and Communications, building on previously announced appointments of Ronald Dadino as Senior Vice President, CMC and Supply Chain, and Gloria Cosgrove as Senior Vice President, Global Quality.

Cash, cash equivalents, and marketable securities were $201.5 million as of September 30, 2026, compared with $187.3 million as of June 30, 2026. The company said the increase was primarily due to proceeds received from the exercise of previously issued warrants.

Total operating expenses for the three months ended September 30, 2026, were $20.5 million, up from $14.7 million a year earlier. Research and development expenses were $6.2 million, and general and administrative expenses were $14.3 million.

Net loss for the three months ended September 30, 2026, was $12.1 million, or $0.11 a share, versus $14.4 million, or $0.28 a share, a year earlier. The quarter included a non-cash gain of $6.9 million related to the change in fair value of warrant liabilities issued in connection with the company’s private placement in the second quarter of 2026. Weighted average basic and diluted common shares were 105.5 million, versus 51.0 million a year earlier.

Halladay said the company is entering the next phase with a strong balance sheet and that his priority is disciplined capital allocation that supports both the NDA resubmission and readiness for a potential U.S. launch in 2027.

Cytisinicline is an investigational compound that binds to nicotinic receptors and is being developed as an oral tablet to aid smoking and e-cigarette cessation in adults. The FDA has granted Breakthrough Therapy designation and a Commissioner’s National Priority Voucher for the vaping cessation program. The smoking-cessation NDA is supported by two completed Phase 3 studies, ORCA-2 and ORCA-3, and the open-label long-term safety study ORCA-OL. The company has also completed a Phase 2 study of cytisinicline in e-cigarette cessation, ORCA-V1, and held an end-of-Phase 2 meeting with the FDA.

Forward-looking statements in the release include the timing and outcome of the planned NDA resubmission and potential FDA approval, the transition of finished drug product manufacturing to Adare, the timing of any potential U.S. commercial launch, and the company’s cash position and use of capital. The company said it may not achieve those plans or obtain regulatory approval on the anticipated timeline or at all, citing among other factors whether it generates stability data sufficient to support the resubmission, whether the resubmission addresses the matters in the FDA’s complete response letter, the outcome of any pre-approval inspection of Adare, the outcome of a dispute with Sopharma AD, and its ability to raise additional capital as needed.