Achieve Life Sciences (NASDAQ: ACHV) deepens 2025 loss while eyeing 2026 FDA decision

Rhea-AI Filing Summary

Achieve Life Sciences reported a larger net loss in 2025 as it advances cytisinicline toward potential approval and commercialization. For 2025, the company posted a net loss of $54.6 million on total operating expenses of $54.9 million, compared to a net loss of $39.8 million in 2024. Cash, cash equivalents, and marketable securities were $36.4 million as of December 31, 2025.

The FDA has accepted Achieve’s New Drug Application for cytisinicline for adult smoking cessation and assigned a PDUFA date of June 20, 2026. Achieve anticipates a potential U.S. commercial launch in the first half of 2027 and has partnered with Adare Pharma Solutions to manufacture cytisinicline in the U.S., aiming to provide supply chain redundancy and potential cost savings. Clinical data from the ORCA program and published studies support cytisinicline’s efficacy and tolerability in smoking cessation, including in people with COPD and those with multiple prior quit attempts.

Insights

Biotech equity analyst

Achieve deepens losses while moving cytisinicline toward a 2026 approval decision and 2027 launch.

Achieve Life Sciences remains a clinical-stage company, generating no product revenue and reporting a 2025 net loss of $54.6M with operating expenses of $54.9M. Cash and marketable securities of $36.4M at December 31, 2025 underpin ongoing development and pre-launch activities.

On the development side, the FDA accepted the cytisinicline NDA for adult smoking cessation and set a June 20, 2026 PDUFA action date. Achieve completed the ORCA-OL long-term exposure trial with 334 participants and highlighted multiple publications and conference presentations reinforcing cytisinicline’s efficacy and tolerability across subgroups and treatment histories.

Commercial readiness steps include selecting Adare Pharma Solutions as a U.S.-based manufacturer, which Achieve expects will reduce importation risk and costs while adding contingency capacity. The company forecasts a potential U.S. launch in the first half of 2027, with Omnicom engaged to build a data-driven commercial model and logistics and specialty pharmacy partners being implemented ahead of the PDUFA decision.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 24, 2026

ACHIEVE LIFE SCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware		033-80623		95-4343413
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)
22722 29th Drive SE, Suite 100 Bothell, WA				98021
1040 West Georgia, Suite 1030 Vancouver, BC, Canada				V6E 4H1
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (604) 210-2217

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of exchange on which registered
Common Stock, par value $0.001 per share	ACHV	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On March 24, 2026, Achieve Life Sciences, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1 104		Press release of Achieve Life Sciences, Inc. dated March 24, 2026 Cover Page Interactive Data File (embedded within the Inline XBRL document)

________________________

The information in Item 2.02 of this Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

________________________

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	ACHIEVE LIFE SCIENCES, INC.
Date: March 24, 2026	/s/ MARK OKI
	Mark Oki Chief Financial Officer (Principal Financial Officer)

Exhibit 99.1

Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

Achieve also Announces Partnership with U.S.-based Adare Pharma Solutions for Cytisinicline Manufacturing

Conference Call Scheduled for 8:30 AM EDT Today, March 24,2026

SEATTLE and VANCOUVER, British Columbia, March 24, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc(Achieve) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced financial results for the fourth quarter and full year 2025 and provided updates on the cytisinicline development program, including the announcement of its partnership with Adare Pharma Solutions (Adare).

“Achieve is fully committed to bringing cytisinicline to the millions of people who continue to struggle with nicotine dependence and need a new solution to help them quit. Much like GLP-1 therapies have transformed the way obesity is treated, shifting it from a lifestyle issue to a recognized medical condition, smoking cessation deserves the same evolution,” said Rick Stewart, President and Chief Executive Officer of Achieve. “Achieve is not quitting on smokers or people who want to quit vaping. We are relentlessly working towards the potential approval of cytisinicline, the initiation of the Phase 3 vaping trial, and a data-driven, highly targeted commercial launch approach.”

Achieve has selected Adare, based in the U.S., to manufacture cytisinicline drug product for potential commercial launch and beyond. Achieve expects this partnership will help decrease risks related to international importation of pharmaceuticals and reduce costs, including potential tariffs. Achieve has commenced the technology transfer to Adare.

In addition to potential cost-savings, the Adare partnership provides supply chain redundancy and U.S.-based contingency capacity. One manufacturer named in the cytisinicline NDA recently underwent an FDA current Good Manufacturing Practices inspection, where two observations related to solid oral dose manufacturing were identified, which are being addressed through an ongoing communication with FDA of its remedial action plan. The company anticipates U.S. commercial launch in the first half of 2027.

Mr. Stewart commented further, “Establishing U.S. manufacturing with Adare increases our confidence in our supply chain and continues our strong progress towards launch.”

Key Highlights

•Made meaningful progress toward regulatory approval in smoking and vaping:

oFDA accepted the cytisinicline NDA for treatment of nicotine dependence for smoking cessation in adults, assigning a PDUFA targeted action date of June 20, 2026.

oCompleted the ORCA-OL long-term exposure trial with 334 participants finishing the one-year study, providing comprehensive long-term safety data for cytisinicline and significantly exceeding the number of patients required for FDA review.

oCytisinicline was selected as one of the first nine therapies chosen for the inaugural FDA Commissioner’s National Priority Voucher for e-cigarette or vaping cessation. The voucher is designed to provide enhanced FDA communications and expedited review, once complete materials are submitted to the FDA.

•Preparation for commercial readiness in anticipation of launch:

oCompleted supply chain and market access readiness activities, including beginning implementation of third-party logistics provider and specialty pharmacy partner selection. Announced partnership with Omnicom across multiple, cross-functional agencies to create a data-driven commercial model designed to execute with precision, scale efficiently and accelerate meaningful engagement for patients and providers.

•Advanced scientific exchange surrounding nicotine dependence, including:

oComplete results from its ORCA-3 trial were published in the Journal of the American Medical Association (JAMA) Internal Medicine.The authors concluded that ORCA-3 reaffirms cytisinicline’s efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks.

oPublication of new data in Thorax demonstrated that cytisinicline significantly increased continuous smoking abstinence versus placebo in both chronic obstructive pulmonary disease (COPD) and non-COPD subgroups. Despite more severe tobacco use histories and greater prior treatment exposure, participants with COPD achieved quit rates comparable to those without COPD.

oPresented new data at the Society for Research on Nicotine and Tobacco (SRNT) 2026 Annual Meeting indicating that cytisinicline delivers meaningful quitting success, regardless of participants' prior use of smoking cessation medications or number of previous quit attempts.

oPresented late-breaking survey data from ORCA-OL at SRNT, which followed participants for up to one year of treatment. The voluntary post-trial survey offered insights into patient-reported experiences with the extended use of cytisinicline beyond the 6- and 12-week courses previously studied.

“Our comprehensive clinical program demonstrates cytisinicline's potential to address a persistent, public health challenge,” said Mark Rubinstein, MD, Chief Medical Officer of Achieve. “The SRNT findings are particularly encouraging because they indicate that cytisinicline helps people quit smoking regardless of their prior treatment history or number of prior attempts, and, if approved, could offer hope to those who have struggled to quit. Combined with our published research on cytisinicline's tolerability profile, we have a comprehensive body

of evidence that could represent a potential new standard of care in nicotine dependence treatment.”

Financial Results
As of December 31, 2025, the company’s cash, cash equivalents, and marketable securities were $36.4 million. Total operating expenses for the three and twelve months ended December 31, 2025, were $14.7 million and $54.9 million, respectively. Total net loss for the three and twelve months ended December 31, 2025, was $14.7 million and $54.7 million, respectively.

Conference Call Details
Achieve will host a conference call at 8:30 a.m. EDT today, Tuesday, March 24, 2026. To access the webcast, please use the following link: 4Q25 Earnings Webcast. Alternatively, you may join the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) and referencing conference ID 13758715. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days.

About Achieve Life Sciences, Inc.
Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.

About Cytisinicline There are approximately 25 million adults in the United States who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3

In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.4 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need.

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. Cytisinicline is an

investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any indication in the United States.

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, including, but not limited to, statements Achieve makes regarding the timing, nature and outcome of cytisinicline clinical development and regulatory review and approval, data results, the timing, nature and success of Achieve’s commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, the performance of Achieve’s third-party manufacturing partners, and the successful launch and commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Achieve Contact
Nicole Jones

VP, Strategic Communications and Stakeholder Relations
ir@achievelifesciences.com
425-686-1510

References 1National Center for Health Statistics. National Health Interview Survey, 2023 and 2024. 2026 (https://www.cdc.gov/nchs/nhis.htm).
2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
4Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

Consolidated Statements of Loss
(In thousands, except per share and share data)
			Three months ended December 31,								Twelve months ended December 31,
			2025				2024				2025				2024
Operating expenses:
Research and development				3,874				7,296				22,998				22,817
General and administrative				10,857				4,894				31,882				16,252
Total operating expenses				14,731				12,190				54,880				39,069
Loss from operations				(14,731	)			(12,190	)			(54,880	)			(39,069	)
Other income (expense)				69				(170	)			232				(758	)
Net loss			$	(14,662	)		$	(12,360	)		$	(54,648	)		$	(39,827	)
Basic and diluted net loss per share			$	(0.28	)		$	(0.36	)		$	(1.25	)		$	(1.24	)
Weighted average number of basic and diluted common shares				53,276,361				34,510,786				43,594,652				32,071,146
Consolidated Balance Sheets
(In thousands)
											December 31,				December 31,
											2025				2024
Assets:
Cash, cash equivalents and marketable securities											$	36,404			$	34,360
Prepaid expenses and other current assets												3,485				2,107
Other assets and restricted cash												52				39
Right-of-use assets												64				119
License agreement												751				974
Goodwill												1,034				1,034
Total assets											$	41,790			$	38,633
Liabilities and stockholders' equity:
Accounts payable and accrued liabilities											$	3,760			$	6,627
Current portion of long-term obligations												61				55
Current portion of convertible debt												3,704				—
Contingent consideration												1,557				1,149
Non-current portion of convertible debt												11,185				9,837
Other long-term obligations												5				66
Stockholders' equity												21,518				20,899
Total liabilities and stockholders' equity											$	41,790			$	38,633

FAQ

What were Achieve Life Sciences (ACHV) full-year 2025 financial results?

Achieve Life Sciences reported a 2025 net loss of $54.6 million on total operating expenses of $54.9 million. Cash, cash equivalents, and marketable securities were $36.4 million as of December 31, 2025, supporting ongoing development and pre-commercial activities for cytisinicline.

What key regulatory milestone did Achieve Life Sciences (ACHV) reach for cytisinicline?

The FDA accepted Achieve’s New Drug Application for cytisinicline for adult smoking cessation and assigned a PDUFA target action date of June 20, 2026. This sets a formal timeline for the U.S. regulatory decision on cytisinicline’s potential approval.

When does Achieve Life Sciences (ACHV) expect to launch cytisinicline in the U.S.?

Achieve anticipates a U.S. commercial launch in the first half of 2027, subject to regulatory approval. The company is preparing supply chain, market access, logistics, and specialty pharmacy partnerships in advance of the cytisinicline PDUFA action date in June 2026.

What manufacturing partnership did Achieve Life Sciences (ACHV) announce for cytisinicline?

Achieve selected Adare Pharma Solutions, a U.S.-based manufacturer, to produce cytisinicline for potential commercial launch and beyond. Achieve expects this collaboration to reduce importation risks and costs, provide supply chain redundancy, and add U.S.-based contingency manufacturing capacity.

What clinical data supports Achieve Life Sciences’ cytisinicline program?

Achieve completed the ORCA-OL long-term exposure trial with 334 participants and reported JAMA Internal Medicine results from ORCA-3 showing efficacy and tolerability. Additional publications and SRNT presentations indicated benefits across COPD and non-COPD subgroups and in people with multiple prior quit attempts.

How is Achieve Life Sciences (ACHV) preparing for cytisinicline commercialization?

Achieve completed supply chain and market access readiness activities, began implementing a third-party logistics provider and specialty pharmacy partners, and partnered with Omnicom to design a data-driven commercial model aimed at efficient scale and targeted engagement for patients and healthcare providers.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 289.1 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 50.2 KB