AchieveRx Reports Third Quarter 2026 Financial Results and Provides Business Updates
Nine-month net loss widened to $97.047 million from $39.986 million, despite a narrower third-quarter loss.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
AchieveRx (Nasdaq: QUIT) reported a narrower third-quarter 2026 net loss while advancing cytisinicline manufacturing and preparations for a potential U.S. launch. Quarterly net loss was $12.110 million, versus $14.441 million a year earlier, including a $6.9 million non-cash warrant valuation gain. Operating expenses rose to $20.535 million from $14.692 million. Cash, cash equivalents and marketable securities reached $201.5 million, versus $187.3 million at June 30, primarily from warrant exercises.
In ORCA-OL, four-week continuous abstinence rose from 25.5% at Weeks 9–12 to 31.2% at Weeks 49–52; no new safety signals were identified. Three commercial-scale stability batches were completed at Adare. The company expects its New Drug Application resubmission in the fourth quarter of 2026 and potential FDA approval by the end of the second quarter of 2027, with a U.S. launch to follow if approved.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointCash, cash equivalents and marketable securities increased to $201.5 million from $187.3 million at June 30, 2026.
- Moderate pointThird-quarter net loss narrowed to $12.110 million from $14.441 million; loss per share fell to $0.11 from $0.28.
- Moderate point. Forward-looking: it has not happened yet and may not happen.AchieveRx expects fourth-quarter 2026 application resubmission and potential approval by end-second-quarter 2027, followed by launch if approved.
- Moderate pointNine-month research and development expenses declined to $13.314 million from $19.124 million a year earlier.
- Minor pointORCA-OL four-week continuous abstinence rose from 25.5% at Weeks 9–12 to 31.2% at Weeks 49–52.
4 minor points
- Minor pointEnd-of-treatment quit rates were 39.4% for participants new to cytisinicline and 27.8% for previously treated participants.
- Minor pointCytisinicline was generally well tolerated over 52 weeks; independent monitoring identified no new safety signals.
- Minor pointAdare manufacturing transition advanced with three commercial-scale stability batches completed at its U.S. facility.
- Minor pointQuarterly results included a $6.9 million non-cash gain from changes in warrant liability fair value.
Negative
- Major pointQuarterly weighted-average common shares increased to 105,477,761 from 51,017,662; warrant exercises primarily drove the sequential cash increase.
- Moderate pointNine-month net loss widened to $97.047 million from $39.986 million; loss per share increased to $1.15 from $0.99.
- Moderate pointNine-month general and administrative expenses rose to $36.076 million from $21.025 million a year earlier.
- Minor pointThird-quarter general and administrative expenses rose to $14.321 million from $9.372 million a year earlier.
- Minor pointThird-quarter research and development expenses rose to $6.214 million from $5.320 million a year earlier.
- Minor pointORCA-OL was an open-label trial in adults still smoking or vaping after a prior counseling-supported quit attempt.
News Explained
One additional holder-relevant measure is the quarterly weighted-average common-share count: AchieveRx reported 105,477,761 for the third quarter of 2026, versus 51,017,662 a year earlier; this is a period average, not a current shares-outstanding figure.
Key Figures
- Cash and marketable securities
- $201.5 million
- As of September 30, 2026
- Net loss
- $12.1 million
- Three months ended September 30, 2026
- Trial enrollment
- 479 adults
- ORCA-OL; participants remained smoking and/or vaping after a prior ORCA trial quit attempt
- Four-week continuous abstinence
- 25.5% to 31.2%
- Weeks 9–12 to Weeks 49–52 of treatment
- End-of-treatment quit rates
- 39.4% and 27.8%
- Participants new to cytisinicline and those who had taken it in a prior trial, respectively
- Commercial-scale stability batches
- 3 batches
- Completed at Adare's U.S. facility
- NDA resubmission
- Fourth quarter of 2026
- Company said resubmission remained on track
- Potential FDA approval
- By the end of the second quarter of 2027
- Company outlook; approval is not stated as granted
Previous Earnings Reports
-
Q2 reported $187.3 million cash and Q4 NDA resubmission plan during Adare manufacturing transition.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
open-label medical
new drug application regulatory
four-week continuous abstinence medical
breakthrough therapy designation regulatory
nicotinic receptors medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Launched new corporate brand as AchieveRx, The Quit Company (Nasdaq: QUIT)
Presented 52-week ORCA-OL data at the CHEST 2026 Annual Meeting showing that nearly one in three adults still smoking or vaping after a supervised quit attempt in a prior trial (a median of five quit attempts among those who smoked) had quit by the end of treatment, with quit rates rising over the course of the year
Expanded leadership with two senior appointments, strengthening the launch team
Completed three commercial-scale stability batches for U.S.-based finished drug product manufacturing; NDA resubmission remains on track for the fourth quarter of 2026
Cash, cash equivalents, and marketable securities of
SEATTLE and VANCOUVER, British Columbia, Nov. 10, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc., doing business as AchieveRx (AchieveRx or the Company) (Nasdaq: QUIT), a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced financial results for the third quarter of 2026 and provided business updates.
“Becoming AchieveRx, The Quit Company, reflects our 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,” said Andrew D. Goldberg, MD, Chief Executive Officer, AchieveRx. “Our 52-week ORCA-OL results add to the growing body of evidence supporting cytisinicline as a potential treatment option for people looking to quit smoking. With an experienced launch team and our NDA resubmission on track for later this year, we are well positioned to bring cytisinicline to people who want to quit, if it is approved.”
Key Highlights
Clinical and Regulatory
- In October, AchieveRx presented 52-week results from its long-term, open-label ORCA-OL trial of cytisinicline 3 mg three times daily at the CHEST 2026 Annual Meeting. The trial enrolled a hard-to-treat population of 479 adults, all of whom were still smoking and/or vaping after a counseling-supported quit attempt in a prior ORCA trial. Participants were in their mid-fifties on average, ranging up to age 79, and many had a history of chronic conditions; those who smoked had made a median of five quit attempts before ORCA-OL. Quit rates (four-week continuous abstinence) rose over the course of treatment, from
25.5% at Weeks 9–12 to31.2% at Weeks 49–52. At the end of treatment,39.4% of participants new to cytisinicline had quit, as had27.8% of those who had taken cytisinicline in a prior trial and were still smoking or vaping. Cytisinicline was generally well tolerated over the 52 weeks, and the independent Data Safety Monitoring Committee identified no new safety signals. - Continued the transition of finished drug product manufacturing of cytisinicline to U.S.-based Adare Pharma Solutions (Adare), completing the production of three commercial-scale stability batches at Adare’s facility. Resubmission of the New Drug Application (NDA) remains on track for the fourth quarter of 2026, and the Company anticipates potential FDA approval by the end of the second quarter of 2027, with U.S. commercial launch to follow, if approved.
Corporate
- Introduced a new corporate brand identity reflecting the Company’s transformation toward a commercial-stage company. As announced on November 9, 2026, Achieve Life Sciences, Inc., is now doing business as AchieveRx, The Quit Company, and has begun trading under the Nasdaq ticker symbol “QUIT.”
- Continued strengthening the leadership team with two senior appointments as the Company moves toward potential commercialization: Ben Halladay as Chief Financial Officer; and Kaitlyn Tuson as Senior Vice President, Marketing and Communications, building on the previously announced appointments of Ronald Dadino as Senior Vice President, CMC and Supply Chain; and Gloria Cosgrove as Senior Vice President, Global Quality.
Financial Results
As of September 30, 2026, the Company’s cash, cash equivalents, and marketable securities were
“The opportunity ahead of us is large, and so is our duty to fund it well,” said Ben Halladay, Chief Financial Officer, AchieveRx. “We’re entering this next phase with a strong balance sheet, and my priority is disciplined capital allocation that supports both our NDA resubmission and readiness for a potential U.S. launch in 2027.”
About AchieveRx
AchieveRx, is a late-stage pharmaceutical company with a singular focus on nicotine dependence. AchieveRx’s mission is to develop medicine for people who want to quit smoking or vaping. That medicine is cytisinicline, an investigational compound. Three ideas guide the Company: simplicity, science, and second chances, for good™. To learn more, visit www.AchieveRx.com.
About Cytisinicline
Cytisinicline is an investigational compound that binds to nicotinic receptors. It is being developed as an oral tablet to aid smoking and e-cigarette cessation in adults. The FDA has granted the vaping cessation program Breakthrough Therapy designation and a Commissioner’s National Priority Voucher. The NDA for cytisinicline for smoking cessation in adults is supported by two successfully completed Phase 3 studies (ORCA-2 and ORCA-3) and an 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
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements regarding the timing and outcome of the Company’s planned NDA resubmission for cytisinicline and potential FDA approval, the Company’s transition of finished drug product manufacturing to Adare, the timing of any potential U.S. commercial launch, the potential benefits of and market for cytisinicline, the Company’s commercialization plans and readiness, the Company’s cash position and use of capital, and the anticipated benefits of new executive leadership. The Company may not achieve its plans, projections, or other expectations and may not be able to successfully complete its NDA resubmission or obtain regulatory approval for cytisinicline on the anticipated timeline or at all. Factors that could cause actual results to differ materially include, among others: whether the Company generates stability data sufficient to support the NDA resubmission on the anticipated timeline; whether the resubmission adequately addresses the matters cited in the FDA’s complete response letter or the FDA requires additional data prior to approval; the outcome of any pre-approval inspection of Adare or other manufacturers and their ability to supply cytisinicline; the outcome of the Company’s dispute with Sopharma AD; the Company’s ability to raise additional capital as needed; and the Company’s ability to successfully commercialize cytisinicline, if approved. These statements are based on management’s current expectations and beliefs and are subject to risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including those detailed in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
Contacts:
Investors
Nicole Jones
ir@achieverx.com
425-686-1510
Media
Kaitlyn Tuson
media@achieverx.com
| Consolidated Statements of Loss | ||||||||||||||||||
| (In thousands, except per share and share data) | ||||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development | 6,214 | 5,320 | 13,314 | 19,124 | ||||||||||||||
| General and administrative | 14,321 | 9,372 | 36,076 | 21,025 | ||||||||||||||
| Total operating expenses | 20,535 | 14,692 | 49,390 | 40,149 | ||||||||||||||
| Loss from operations | (20,535 | ) | (14,692 | ) | (49,390 | ) | (40,149 | ) | ||||||||||
| Other income | 8,425 | 251 | (47,657 | ) | 163 | |||||||||||||
| Net loss | $ | (12,110 | ) | $ | (14,441 | ) | $ | (97,047 | ) | $ | (39,986 | ) | ||||||
| Basic and diluted net loss per share | $ | (0.11 | ) | $ | (0.28 | ) | $ | (1.15 | ) | $ | (0.99 | ) | ||||||
| Weighted average number of basic and diluted common shares | 105,477,761 | 51,017,662 | 84,314,259 | 40,189,095 | ||||||||||||||
| Consolidated Balance Sheets | ||||||||||||||||||
| (In thousands) | ||||||||||||||||||
| September 30, | December 31, | |||||||||||||||||
| 2026 | 2025 | |||||||||||||||||
| Assets: | ||||||||||||||||||
| Cash, cash equivalents and marketable securities | $ | 201,518 | $ | 36,404 | ||||||||||||||
| Prepaid expenses and other current assets | 1,894 | 3,485 | ||||||||||||||||
| Other assets and restricted cash | 253 | 52 | ||||||||||||||||
| Right-of-use assets | 974 | 64 | ||||||||||||||||
| Other intangible assets | 166 | — | ||||||||||||||||
| License agreement | 584 | 751 | ||||||||||||||||
| Goodwill | 1,034 | 1,034 | ||||||||||||||||
| Total assets | $ | 206,423 | $ | 41,790 | ||||||||||||||
| Liabilities and stockholders' equity: | ||||||||||||||||||
| Accounts payable and accrued liabilities | $ | 10,240 | $ | 3,760 | ||||||||||||||
| Current portion of long-term obligations | 286 | 61 | ||||||||||||||||
| Current portion of convertible debt | 7,454 | 3,704 | ||||||||||||||||
| Contingent consideration | 1,407 | 1,557 | ||||||||||||||||
| Non-current portion of convertible debt | 5,595 | 11,185 | ||||||||||||||||
| Other long-term obligations | 712 | 5 | ||||||||||||||||
| Stockholders' equity | 180,729 | 21,518 | ||||||||||||||||
| Total liabilities and stockholders' equity | $ | 206,423 | $ | 41,790 | ||||||||||||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were AchieveRx's third-quarter 2026 financial results?
AchieveRx reported a $12.110 million net loss, or $0.11 per share, compared with $14.441 million, or $0.28 per share, a year earlier. Operating expenses increased to $20.535 million from $14.692 million. The quarter included a $6.9 million non-cash gain related to warrant liabilities.
When does AchieveRx expect to resubmit the cytisinicline application and potentially launch?
AchieveRx expects to resubmit its New Drug Application in the fourth quarter of 2026 and anticipates potential FDA approval by the end of the second quarter of 2027. A U.S. commercial launch would follow if approved.
Who participated in AchieveRx's ORCA-OL cytisinicline trial?
ORCA-OL enrolled 479 adults who were still smoking and/or vaping after a counseling-supported quit attempt in a prior ORCA trial. Participants were in their mid-fifties on average, with ages ranging up to 79. Those who smoked had made a median of five quit attempts before ORCA-OL.
Why did AchieveRx change its name and stock ticker?
AchieveRx describes its new brand as reflecting its transition toward a commercial-stage company. Achieve Life Sciences now does business as AchieveRx, The Quit Company, and has begun trading on Nasdaq under QUIT, as announced November 9, 2026.
Who joined AchieveRx's leadership team ahead of potential commercialization?
Ben Halladay joined as Chief Financial Officer, and Kaitlyn Tuson joined as Senior Vice President, Marketing and Communications. These appointments build on the previously announced additions of Ronald Dadino for CMC and Supply Chain and Gloria Cosgrove for Global Quality.