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

Rhea-AI Summary

Achieve Life Sciences (Nasdaq: ACHV) reported 4Q and full‑year 2025 results and development updates for cytisinicline. Key regulatory progress includes FDA acceptance of the NDA with a PDUFA date of June 20, 2026. The company completed the 334‑participant ORCA‑OL yearlong safety study and announced a U.S. manufacturing partnership with Adare Pharma Solutions to support a planned U.S. commercial launch in H1 2027.

As of December 31, 2025, cash and marketable securities were $36.4M; 2025 net loss was $54.7M with operating expenses of $54.9M. Conference call held March 24, 2026.

Positive

• FDA NDA accepted with PDUFA date June 20, 2026
• Completed ORCA‑OL 334‑participant one‑year safety trial
• Adare U.S. manufacturing partnership for commercial supply
• Published ORCA‑3 results in JAMA Internal Medicine

Negative

• Net loss $54.7M for the twelve months ended Dec 31, 2025
• Cash $36.4M as of Dec 31, 2025 may pressure near‑term funding

News Market Reaction – ACHV

-28.40% 8.9x vol

50 alerts

-28.40% News Effect

-26.0% Trough in 7 hr 43 min

-$86M Valuation Impact

$215.60M Market Cap

8.9x Rel. Volume

On the day this news was published, ACHV declined 28.40%, reflecting a significant negative market reaction. Argus tracked a trough of -26.0% from its starting point during tracking. Our momentum scanner triggered 50 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $86M from the company's valuation, bringing the market cap to $215.60M at that time. Trading volume was exceptionally heavy at 8.9x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & securities: $36.4M Operating expenses (Q4 2025): $14.7M Operating expenses (FY 2025): $54.9M +5 more

8 metrics

Cash & securities $36.4M As of December 31, 2025

Operating expenses (Q4 2025) $14.7M Three months ended December 31, 2025

Operating expenses (FY 2025) $54.9M Twelve months ended December 31, 2025

Net loss (Q4 2025) $14.7M Three months ended December 31, 2025

Net loss (FY 2025) $54.7M Twelve months ended December 31, 2025

ORCA-OL participants 334 participants Completed one-year long-term exposure trial

PDUFA date June 20, 2026 FDA targeted action date for cytisinicline NDA

Shelf registration size $300,000,000 Form S-3 effective January 23, 2026

Market Reality Check

Price: $2.65 Vol: Volume 550,501 is 1.49x t...

normal vol

$2.65 Last Close

Volume Volume 550,501 is 1.49x the 20-day average of 370,695, indicating elevated trading interest ahead of the update. normal

Technical Shares at $4.05 are trading above the $3.83 200-day moving average and about 33% below the $6.03 52-week high.

Peers on Argus

Peer biotech names showed a mixed tape, with movers like CHRS (+5.13%) and ELDN ...

1 Up

Peer biotech names showed a mixed tape, with movers like CHRS (+5.13%) and ELDN (+3.86%) up while MIST (-7.01%) and NVCT (-2.02%) were down. Momentum data flag only MIST on the scanner, moving up, while the target stock was flagged as moving down, pointing to a stock-specific setup rather than a coordinated sector move.

Previous Earnings Reports

5 past events · Latest: Nov 06 (Neutral)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Neutral	-3.9%	Reported Q3 2025 results and NDA acceptance with PDUFA June 20, 2026.
Aug 07	Q2 2025 earnings	Neutral	+0.0%	Q2 2025 results, NDA submission, Omnicom partnership, and $49.3M equity raise.
May 13	Q1 2025 earnings	Neutral	+6.8%	Q1 2025 results and plans for NDA submission with ORCA-3 data update.
Mar 11	FY 2024 results	Neutral	-4.6%	Q4 and 2024 results plus ORCA-OL progress and vaping trial plans.
Nov 07	Q3 2024 earnings	Neutral	-7.4%	Q3 2024 results, ORCA-OL enrollment completion, and Breakthrough designation.

Pattern Detected

Across the last 5 earnings-related releases, price reactions were often negative, with 3 declines and only 1 clearly positive move, suggesting prior earnings and program updates have not consistently translated into upside.

Recent Company History

Over the past year, Achieve’s earnings updates have tracked steady progress in the cytisinicline program. Earlier releases highlighted Breakthrough Therapy designation, NDA submission, and FDA acceptance with a June 20, 2026 PDUFA date. Cash balances around $34.4M–$55.4M and recurring net losses underscored ongoing funding needs. Today’s Q4 and full-year 2025 results continue that narrative, adding an Adare manufacturing deal, commercial-readiness steps, and an anticipated U.S. launch in the first half of 2027.

Historical Comparison

-1.8% avg move · In the last five earnings-type releases, ACHV’s average move was -1.8%, showing that even positive r...

earnings

-1.8%

Average Historical Move earnings

In the last five earnings-type releases, ACHV’s average move was -1.8%, showing that even positive regulatory and clinical milestones around cytisinicline have often been met with cautious trading.

Earnings updates have traced cytisinicline’s path from late-stage development, through NDA submission and FDA acceptance with a defined PDUFA date, toward preparation for commercial launch and vaping-related indications.

Regulatory & Risk Context

Active S-3 Shelf · $300,000,000

Shelf Active

Active S-3 Shelf Registration 2026-01-23

$300,000,000 registered capacity

An effective Form S-3 filed on January 23, 2026 allows Achieve to issue up to $300,000,000 of various securities over time, with proceeds earmarked for general corporate uses including R&D, manufacturing, commercialization, working capital, debt reduction, acquisitions, or capital spending.

Market Pulse Summary

The stock dropped -28.4% in the session following this news. A negative reaction despite operational...

Analysis

The stock dropped -28.4% in the session following this news. A negative reaction despite operational progress would fit a history where earnings-related news produced an average move of -1.8%. Persistent net losses, including a $54.7M loss for 2025, may continue to anchor sentiment even as cytisinicline advances toward its June 20, 2026 PDUFA date and a planned 2027 launch. The effective $300M shelf registration also underscores ongoing financing flexibility that markets may discount.

Key Terms

new drug application (nda), pdufa, current good manufacturing practices, phase 3, +3 more

7 terms

new drug application (nda) regulatory

"including the submission of a New Drug Application (NDA) to the FDA"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

pdufa regulatory

"assigning a PDUFA targeted action date of June 20, 2026"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

current good manufacturing practices regulatory

"underwent an FDA current Good Manufacturing Practices inspection, where two observations"

Current good manufacturing practices (cGMPs) are the regulatory standards that govern how medicines, medical devices, and other regulated products must be made to ensure consistent safety, purity, and quality. Think of them as a strict recipe and kitchen rules—clean facilities, trained staff, documented steps, and quality checks—so each batch turns out the same. For investors, cGMP compliance reduces the risk of product recalls, regulatory fines, production shutdowns, and damage to long-term revenue and reputation.

phase 3 medical

"the initiation of the Phase 3 vaping trial, and a data-driven"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

specialty pharmacy technical

"third-party logistics provider and specialty pharmacy partner selection"

A specialty pharmacy is a pharmacy that focuses on dispensing and managing high-cost, complex medications that often need special storage, handling, administration or ongoing patient monitoring—think of it as a concierge service for drugs that require extra care. Investors pay attention because these pharmacies control access, support adherence and billing for expensive treatments, which affects drug sales, reimbursement, margins and long-term revenue predictability for manufacturers and payers.

chronic obstructive pulmonary disease (copd) medical

"versus placebo in both chronic obstructive pulmonary disease (COPD) and non-COPD subgroups"

A long-term lung disease that makes it increasingly hard to breathe because airways become narrowed or damaged; think of it like a gradually clogged air filter that reduces airflow and resistance to everyday activity. It matters to investors because COPD drives persistent demand for medications, inhalers, diagnostic tools and hospital services, influences healthcare spending and regulatory review of new treatments, and can shape long-term revenue and risk profiles for companies in respiratory care.

long-term exposure trial medical

"Completed the ORCA-OL long-term exposure trial with 334 participants"

A long-term exposure trial is a clinical study that monitors people or animals for extended periods to see the effects of prolonged contact with a drug, chemical, or medical treatment. Like watching how a car performs after years of daily use, these trials reveal slow-developing benefits or harms that short studies can miss, and investors use the results to judge long-term safety, regulatory risk, and the potential market lifespan of a product.

AI-generated analysis. Not financial advice.

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:
  • FDA accepted the cytisinicline NDA for treatment of nicotine dependence for smoking cessation in adults, assigning a PDUFA targeted action date of June 20, 2026.
  • Completed 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.
  • Cytisinicline 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:
  • Completed 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:
  • Complete 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.
  • Publication 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.
  • Presented 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.
  • Presented 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 AM 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 is Achieve Life Sciences' PDUFA date for cytisinicline (ACHV)?

The PDUFA target action date is June 20, 2026. According to the company, the FDA accepted the cytisinicline NDA and set that target date for the review of smoking cessation approval.

How many participants completed Achieve's ORCA‑OL long‑term cytisinicline trial (ACHV)?

A total of 334 participants completed the one‑year ORCA‑OL trial. According to the company, this provides comprehensive long‑term safety data substantially exceeding FDA review requirements.

What manufacturing plans did Achieve announce for cytisinicline (ACHV)?

Achieve partnered with Adare Pharma Solutions for U.S. drug product manufacturing. According to the company, technology transfer has commenced to reduce import risks, lower costs, and add U.S. contingency capacity.

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

Achieve anticipates a U.S. commercial launch in the first half of 2027. According to the company, commercial readiness work and supply chain setup are underway to support that timeline.

What were Achieve's cash and net loss figures for 2025 (ACHV)?

As of Dec 31, 2025, cash and marketable securities were $36.4M, and the full‑year net loss was $54.7M. According to the company, operating expenses for 2025 totaled $54.9M.

Did Achieve publish clinical data supporting cytisinicline efficacy (ACHV)?

Yes; ORCA‑3 results were published in JAMA Internal Medicine, and new data appeared in Thorax. According to the company, publications and SRNT presentations reinforce efficacy and tolerability across subgroups.