Latest news with #AchieveLifeSciences
Business Insider
3 days ago
- Business
- Business Insider
Raymond James Predicts Up to ~760% Surge for These 2 ‘Strong Buy' Stocks
With the summer of 2025 in full swing, all eyes are on President Trump's trade moves once again. Over the past week, Trump announced a 35% tariff on most Canadian imports, set a 50% tariff on select Brazilian goods, and warned that a broader set of tariff hikes for other major trading partners could take effect as soon as August 1 if new trade agreements aren't reached. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. Naturally, all this has stirred up some uncertainty – especially for investors trying to read the tea leaves on inflation, supply chains, and overall market direction. And yet, Raymond James CIO Larry Adam sees plenty of reason for optimism when looking at the bigger picture. 'For investors, market ups and downs are nothing new. Despite interim setbacks, the S&P 500 has delivered a robust average annual return of ~11% since 1985. Bull markets historically last six times longer than bear markets and produce returns five times more powerful. The takeaway? Stay focused on the long term,' Adam notes. That long-term perspective leads to a clear track, and Adam elaborates on it, saying, 'We continue to favor U.S. equities, where the outlook remains brighter… We expect two rate cuts by year end and two more in 2026, helping growth pick up to 1.5% next year. Trump's 'One Big Beautiful Bill' could also provide a modest boost, even if it adds to the deficit.' Against this backdrop, Raymond James analysts have zeroed in on two stocks they believe are set for substantial growth in the coming year – including one with a potential upside as high as 760%. As if that weren't compelling enough, both names also earn a Strong Buy rating from the analyst consensus, according to the TipRanks database. Let's break down what's behind the bullish sentiment. Achieve Life Sciences (ACHV) We'll start with a stock that is bursting with upside potential. Achieve Life Sciences is both a biopharmaceutical company and a penny stock – two niches known for their ability to deliver outsized returns. Central to the company's growth story is its lead program: developing treatments for nicotine dependence. Nicotine, the key addictive ingredient in tobacco products, has been connected to multiple health problems, including recurrent headaches, high blood pressure, dangerous blood clotting, sleep disorders, and changes in heart rhythm. The most common way that people satisfy their nicotine cravings is through smoking, which brings along its own array of health issues, from COPD to various cancers. This isn't just a health challenge – it's a massive market opportunity. There are 29 million smokers in the US alone, some 16 million Americans living with smoking-related illnesses, and globally, about 8 million smoking-related deaths each year. Achieve is targeting the problem with the development of cytisinicline, a naturally derived drug candidate designed to reduce withdrawal symptoms and make it easier to quit smoking or vaping. What sets cytisinicline apart is its robust clinical profile. The drug has delivered strong Phase 3 data on smoking cessation, with a favorable safety record to match. In the ORCA-2 and ORCA-3 trials, cytisinicline consistently produced statistically significant improvements in abstinence rates versus placebo. In ORCA-3, 30.3% of participants in the 12-week arm achieved continuous abstinence during weeks 9 to 12, compared to 9.4% with placebo, and about 20.5% remained abstinent through week 24 versus 4.2% for placebo. The safety profile was favorable, with mostly mild to moderate side effects and no treatment-related serious adverse events. These findings were reinforced by the ORCA-OL trial, where the independent DSMC's third safety review identified no concerns with long-term cytisinicline use. Now, Achieve is gearing up for the next phase: FDA approval and commercial launch. At the end of June, the company submitted a New Drug Application (NDA) to the FDA. If approved, cytisinicline will become the first FDA-approved drug therapy for nicotine addiction in the past two decades. To support its commercialization efforts, Achieve recently announced a strategic partnership with Omnicom and has raised about $45 million. Moreover, Achieve is not stopping with traditional smokers. The company is advancing cytisinicline as a potential treatment for nicotine dependence in e-cigarette users as well. In the Phase 2 ORCA-V1 trial, cytisinicline produced higher quit rates than placebo among individuals seeking to quit vaping, with no serious adverse events reported. Following these results, Achieve held an end-of-Phase 2 meeting with the FDA and reached agreement on the design of a pivotal Phase 3 trial for vaping cessation. With that green light, the company plans to kick off the ORCA-V2 Phase 3 study in the first half of 2026. Put it all together – the compelling data, the unmet need, the imminent FDA milestone, and a bargain-bin $2.32 share price – and it's no wonder Raymond James analyst Gary Nachman thinks now is the time to get in on the action. 'Our Strong Buy rating is supported by a significant unmet need still in the [nicotine addiction] market that is a major global public health concern, with current options resulting in very low quit rates. Cytisinicline has a compelling clinical profile with strong Phase 2/3 data. Cytisinicline shows high smoking cessation quit rates and a favorable safety profile compared to PFE's Chantix (peak sales $1.1B) that is now generic. Cytisinicline has a proven mechanism that is similar to Chantix, but is naturally derived and more selective resulting in fewer AEs, has 50+ years of safe use in E. Europe, and now a submitted NDA with a de-risked regulatory pathway,' Nachman opined. 'There is a large opportunity in smoking cessation that is ripe for the taking and an expanded partnership with Omnicom should help with the US launch, and potentially big upside from vaping as well… A partnership/acquisition to maximize value is possible,' the analyst added. All of this helps explain Nachman's Strong Buy rating on ACHV, which comes with a $20 price target. If his thesis plays out, investors could be looking at a whopping ~760% gain over the next 12 months. (To watch Nachman's track record, click here) And it's not just Nachman who sees big upside here. The broader analyst community is similarly upbeat: in the past 3 months, ACHV has picked up 4 Buy ratings with no Holds or Sells, earning it a consensus Strong Buy status on Wall Street. Meanwhile, the average price target of $15.25 points to a 557% upside from current levels. (See ACHV stock forecast) Avidity Biosciences (RNA) The next stock catching Raymond James' attention is Avidity Biosciences, a clinical-stage biotech firm aiming to develop a new class of RNA therapeutics – drug candidates designed to tackle the root genetic causes behind a variety of serious diseases. The company is building its pipeline using its proprietary Antibody Oligonucleotide Conjugates platform, or AOC. This platform blends the targeting abilities of monoclonal antibodies with the gene-silencing power of oligonucleotide therapies, creating agents that can home in on disease drivers at the genetic level with notable selectivity and precision. Through this approach, Avidity aims to address conditions that have long eluded effective treatment. At present, the company's primary targets are skeletal muscle diseases, especially within the muscular dystrophy class. Avidity has developed a robust research pipeline, which includes three lead drug candidates that are advancing through clinical trials. These three programs – Del-zota, Del-desiran, and Del-brax – are each aimed at specific muscle disorders: Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), and facioscapulohumeral muscular dystrophy (FSHD), respectively. Each of these candidates has shown solid progress. Del-zota, Avidity's program for Duchenne muscular dystrophy, has demonstrated strong increases in exon skipping and dystrophin production, along with an encouraging safety profile. Based on these results, the company expects to submit its first Biologics License Application (BLA) for del-zota by year-end. Meanwhile, del-desiran has delivered impressive data in early clinical trials, with patients experiencing not only reductions in toxic RNA but also meaningful signs of functional improvement. These encouraging results have been further supported by the ongoing MARINA-OLE extension study, which continues to show sustained benefit with longer-term treatment. On the strength of these findings, the program advanced into the pivotal Phase 3 HARBOR trial. The company previously noted that enrollment would be completed by mid-2025, setting the stage for comprehensive data readouts in the first half of 2026. Rounding out the pipeline, the del‑brax program for FSHD is also advancing steadily. Initial data from the FORTITUDE study demonstrated significant reductions in DUX4 gene expression, and with an FDA‑validated accelerated approval pathway now in place, Avidity launched the pivotal FORWARD Phase 3 trial. This global, 18‑month, randomized, placebo‑controlled study is expected to deliver topline results by H2 2026. With all three programs advancing toward key clinical and regulatory milestones, Raymond James analyst Martin Auster sees strong prospects for success here. 'We have high conviction in del-zota (DMD44) to become the first approved drug from Avidity's antibody oligonucleotide conjugate (AOC) platform. Del-desiran (DM1) has been derisked through Ph1/2 biomarker and functional data, and a positive Ph 3 outcome in ~H1 2026 could be transformative for Avidity given del-desiran's first-mover potential and a large DM1 market opportunity (~$5B+ TAM). Del-brax has an even larger potential first-mover advantage in FSHD (opportunity for a strong competitive moat); we project accelerated approval in 2027 supported by cDUX biomarker data and 12-month placebo-controlled functional data,' Auster stated. Auster's high conviction is reflected in his Strong Buy rating on RNA and a $65 price target, which suggests a potential 107% upside from current levels. (To watch Auster's track record, click here) That's far from the only upbeat take on this stock. RNA enjoys a Strong Buy consensus, based on 18 recent analyst ratings – with 17 Buys and just a single Hold. At its current price of $31.45, the stock's average target price of $64.44 suggests RNA could surge ~105% in value over the next year. (See RNA stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights.
Yahoo
07-07-2025
- Business
- Yahoo
Omnicom, Achieve Life Sciences Partner for AI-Driven Launch of New Nicotine Dependence Treatment
Omnicom Group Inc. (NYSE:OMC) is one of the best high short interest stocks with huge upside potential. On June 26, Achieve Life Sciences Inc. (NASDAQ:ACHV) announced a strategic innovation partnership with Omnicom. Omnicom has been named Achieve's agency of record to lead initiatives for the US commercial launch of cytisinicline, which is positioned to be the first potential new treatment for nicotine dependence in nearly two decades. The expanded partnership builds on an existing relationship and aims for a technology-led, integrated, and data-driven launch strategy. The US launch platform for cytisinicline is being developed by Credera, which is Omnicom's technology powerhouse and uses AI-enabled marketing technology proven in healthcare and other industries for precise targeting, optimized channel performance, and accelerated engagement with healthcare professionals and patients. A social media specialist crafting new ideas for healthcare marketing campaigns on a laptop. Omnicom has assembled a unified agency team that draws on specialized talent from Goodby, Silverstein & Partners for consumer brand development, DDB Health for medical education, and Ketchum Health for strategic public relations and communications. The cross-functional approach applies proven insights from different industries to set a new standard for biopharma commercialization. Omnicom Group Inc. (NYSE:OMC) offers advertising, marketing, and corporate communications services. Achieve Life Sciences Inc. (NASDAQ:ACHV) is a late-stage pharmaceutical company that develops and commercializes cytisinicline for nicotine independence in Canada, the US, and the UK. While we acknowledge the potential of OMC as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error al recuperar los datos Inicia sesión para acceder a tu cartera de valores Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos
Yahoo
07-07-2025
- Business
- Yahoo
Should You Hold Achieve Life Sciences (ACHV)?
Rogue Funds, an investment management company, released its first quarter 2025 investor letter. A copy of the letter can be downloaded here. The fund depreciated 12.4% net of fees in the quarter. The firm anticipates significant volatility in the near future. Because of the Fund's concentration, significant declines as well as significant rises in the total returns throughout the course of the year are not unusual. In addition, you can check the fund's top 5 holdings to determine its best picks for 2025. In its first quarter 2025 investor letter, Rogue Funds highlighted stocks such as Achieve Life Sciences, Inc. (NASDAQ:ACHV). Achieve Life Sciences, Inc. (NASDAQ:ACHV) is a clinical-stage pharmaceutical company. The one-month return of Achieve Life Sciences, Inc. (NASDAQ:ACHV) was -43.08%, and its shares lost 51.98% of their value over the last 52 weeks. On July 3, 2025, Achieve Life Sciences, Inc. (NASDAQ:ACHV) stock closed at $2.18 per share, with a market capitalization of $108.314 million. Rogue Funds stated the following regarding Achieve Life Sciences, Inc. (NASDAQ:ACHV) in its first quarter 2025 investor letter: "Achieve Life Sciences, Inc. (NASDAQ:ACHV) (Stock and Calls): You can read more about this investment on the Rogue Funds blog here. The company released their first long term trial results in early January and showed zero safety concerns. Despite this being one of the more confident positions for us, it has been an extremely frustrating ride for the Fund and has caused a severe drag in performance that I am not proud of. The current valuation is frankly ludicrous. They delayed NDA filing to June and right after the NDA they will get the July results back, which I expect to be great. They will most likely have to push for a raise to get to PDUFA (likely Q2 of 2026 unless the FDA speeds up approval timelines). In the meantime, after the NDA I still expect a rise in the stock price as they are extremely undervalued to their market potential. After the July study results, if they turn out to be good, it will be very hard to see why they would not be an obvious take-out target. Even with a raise, I still expect the company to have 5x-8x upside from where they are today." A scientist in a lab coat discussing clinical trial results in a laboratory. Achieve Life Sciences, Inc. (NASDAQ:ACHV) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 9 hedge fund portfolios held Achieve Life Sciences, Inc. (NASDAQ:ACHV) at the end of the first quarter, compared to 9 in the fourth quarter. While we acknowledge the potential of Achieve Life Sciences, Inc. (NASDAQ:ACHV) as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is as promising as NVIDIA but that trades at less than 5 times its earnings, check out our report about the undervalued AI stock set for massive gains. In another article, we covered Achieve Life Sciences, Inc. (NASDAQ:ACHV) and shared Rogue Funds' views on the company in the previous quarter in the previous quarter. In addition, please check out our hedge fund investor letters Q1 2025 page for more investor letters from hedge funds and other leading investors. While we acknowledge the potential of ACHV as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
06-07-2025
- Business
- Globe and Mail
Achieve Life Sciences Announces Partnership with Omnicom to Execute Integrated, Data-Driven Launch of the First Potential New Treatment for Nicotine Dependence in Nearly Two Decades
Omnicom cross-agency collaboration to drive technology-led, innovative launch strategy Partnership brings together promising science, top-tier talent, and advanced technologies to enable a faster, smarter, and more effective path to address a critical public health need SEATTLE and VANCOUVER, British Columbia, June 26, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced it has named Omnicom (NYSE: OMC) as its strategic innovation partner and agency of record to lead initiatives in support of Achieve's planning for U.S. commercial launch. 'We're excited to expand our partnership with Omnicom, building on the strong foundation we've established over the past several years,' said Jaime Xinos, Chief Commercial Officer of Achieve Life Sciences. 'This fully integrated extension of our commercial team shares the belief that the first treatment innovation for nicotine dependence in decades should be matched by an equally modern and strategic launch approach.' Led by Omnicom's technology powerhouse, Credera, Achieve's U.S. launch platform is being developed based on world-class, AI-enabled marketing technology proven across healthcare and other industries to enhance precision targeting, optimize channel performance, and accelerate meaningful engagement with both healthcare professionals and patients. 'To be selected by Achieve to help address a major public health crisis is truly an honor,' said Michael Collins, President, Health & Wellness for Omnicom Advertising Collective. 'Over the past several years, Achieve Life Sciences has been singularly focused on preparing to transform the nicotine dependence market and we are deeply committed to building a best-in-class approach with top talent and tools from across the network to help Achieve realize the full potential of cytisinicline.' Along with Credera, to deliver a comprehensive and connected commercialization strategy, Omnicom has assembled a unified agency team drawing on specialized talent from Goodby, Silverstein & Partners, DDB Health, and Ketchum Health. This cross-functional team will provide expertise in consumer brand development, medical education, and strategic public relations and communications, applying proven insights from across industries to support a launch strategy designed to set a new standard for biopharma commercialization. Xinos continued, 'As an emerging biopharma company, we recognize we can't follow the traditional playbook historically used to launch new medicines. We're designing a launch platform that's purpose-built for a company bringing its first product to market in today's environment. It leverages data-driven insights to guide decisions and deploy resources with precision, agility, and efficiency. These aren't untested ideas—they're established best practices in marketing excellence, and we're applying them with focus and intent to drive value across our stakeholders.' Smoking remains the leading cause of preventable death and disease in the U.S., with over 29 million adults still smoking. Achieve has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and has fully enrolled its ongoing open-label safety study. Achieve announced it submitted its new drug application (NDA) for cytisinicline as a treatment of nicotine dependence for smoking cessation on June 25, 2025. If approved, Achieve aims to help address this ongoing public health crisis by making cytisinicline available to those ready to quit and providing them with a new, evidence-based path to cessation. Achieve's collaboration with Omnicom enables the integration of innovative technologies like generative AI, predictive analytics and social listening to enhance targeting and personalization and will also include partnerships with healthcare apps, pharmacies, and data providers to expand the reach and depth of insights, making Achieve's approach uniquely comprehensive. 'We're so proud to have been chosen by Achieve Life Sciences and to be part of history by addressing one of the biggest public health issues of our time and applying our latest technologies and offerings to ensure a highly successful launch,' said Michele Markus, Head of Global Health Accounts for Omnicom. 'This issue is personal for many of us and the commitment and dedication of our integrated team reflects our belief in their mission – one we know has the ability to significantly save and change lives.' About Achieve Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. In June 2025, the company submitted its New Drug Application to the FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its fully enrolled 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 29 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 approximately 17 million adults in the United States who use e-cigarettes, also known as vaping. 4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes. 5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA 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 Food and Drug Administration for any indication in the United States. About Omnicom Group Inc. Omnicom Group Inc. (NYSE: OMC) ( is a leading global marketing and corporate communications company. Omnicom's branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations and other specialty communications services to over 5,000 clients in more than 70 countries. Follow us on X for the latest news. About Goodby, Silverstein & Partners At Goodby Silverstein & Partners, we believe in mass intimacy—creating campaigns that speak to millions but feel like they're made just for you. We combine brilliant strategy, breakthrough creativity and the innovative use of technology to build enduring ideas that drive results for some of the world's most iconic brands. While maintaining our independent spirit, our network affiliation provides global scale and access to proprietary tools and discipline-specific specialists including PR, multicultural, experiential and media. Visit us at About DDB Health DDB Health is a global network of healthcare communications companies. At DDB Health we are 100% dedicated to healthcare, particularly in the specialty science space. DDB Health specializes in HCP promotions, including brand and campaign development, insight/data generation, portfolio management, scientific branding, and market-shaping activities, ensuring customers are educated in the latest advancements to help them engage effectively with patients and caregivers. We are uniquely supported by a range of specialized services, including multichannel engagement, innovation experts, strategic planning, medical execution, and data and analytics. As a part of Omnicom Health, DDB Health has access to in-network resources with expertise in payer, media, and medical education. Visit us at About Credera Credera is a global, boutique consulting firm that creates measurable results at the intersection of strategy, data, innovation, and technology. Credera works with leading companies across the globe from strategy through execution at offices in 16 countries. Credera's deep business acumen and technical expertise, combined with a true dedication to building trusted relationships, unlocks remarkable performance for our clients. Our mission is to make an extraordinary impact on our clients, our people, and our communities. Visit us at Credera. About Ketchum Established in 1923, Ketchum's century of continuous evolution is a testament to our progress. Our storied journey is fueled by our guiding principles of empathy and intelligence. Progress allows us to create a thriving environment where we embrace innovation and deliver excellence with our people and partners, producing work that matters. Driven by data, we develop culture-first work at the intersection of industry and capability. With 150+ Cannes Lions, our global communications consultancy is one of the most creatively awarded firms in our industry. We are Ketchum: Progress at Work. For more information on Ketchum, a part of Omnicom PR Group, visit 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 regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful 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, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, 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. Achieve Contact Nicole Jones ir@ 425-686-1510 References 1 VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641. 2 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3 U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4 Vahratian A, Briones EM, Jamal A, Marynak KL. Electronic cigarette use among adults in the United States, 2019–2023. NCHS Data Brief, no 524. Hyattsville, MD: National Center for Health Statistics. 2025. DOI: 10.15620/cdc/174583. 5 Jamal 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.
Yahoo
06-07-2025
- Business
- Yahoo
ACHV: Achieve's Busy Day
By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) posted a flurry of press releases last week announcing the submission of its new drug application (NDA), a partnership with Omnicom for cytisinicline commercialization, a proposed public offering and the pricing of the offering. The capital raise was closed on June 30th. This is the culmination of more than a decade of work developing cytisinicline for smoking cessation. Now that the development phase of cytisinicline for smoking cessation is coming to a close, we look towards the regulatory and commercialization phases. We expect to see the FDA formally accept the NDA by late August and Achieve's management team to turn its attention towards the sales effort. Assuming normal turnaround times, we expect the FDA to set a target action date sometime in 2Q:26. NDA Submission Achieve announced its NDA submission of cytisinicline for smoking cessation in a June 26th press release. The company conducted two Phase III studies, an open label safety study and other studies that evaluated over 2,000 participants with the results demonstrating the safety, efficacy and tolerability of cytisinicline. We expect to see acceptance of the NDA within 60 days and further expect additional safety data from the ongoing ORCA-OL trial to be shared with the agency near year end. Commercialization Partnership Now that the new drug application has been submitted, Achieve is further advancing its commercialization efforts. During its earnings calls, the company has outlined its commercialization strategy and is now partnering with Omnicom Group to execute the plan. Omnicom Group provides brand and advertising services to thousands of clients globally and is one of the world's largest advertising and marketing services companies. Achieve will work with Omnicom subsidiary Credera, which is focused on digital transformation services. Credera combines consulting, artificial intelligence (AI) and technology expertise to build consumer technology platforms, integrate marketing technology systems and provide strategic consulting services. It will help Achieve to precisely target and engage healthcare professionals and patients through optimization of channel performance and acceleration of meaningful engagement. The team executing the initiative will include Goodby, Silverstein & Partners, DDB Health, and Ketchum Health which are health care-focused subsidiaries of the Omnicom marketing group. The various subsidiaries will provide expertise in consumer brand development, medical education and strategic public relations and communications, applying industry insights to support cytisinicline launch. In the Achieve partnership, Ketchum Health brings public relations and communications expertise, while Credera handles technology, Goodby Silverstein provides creative advertising, and DDB Health focuses on healthcare marketing. The partnership will use generative AI, predictive analytics and social listening to enhance targeting and personalization. Using a comprehensive approach, it will also employ healthcare applications, pharmacies and data providers to expand the reach and depth of insights. Omnicom has worked as media agency, digital and brand experience for other pharmaceutical and biotechnology clients including established firms such as AbbVie, AstraZeneca, Novartis and Moderna among others. Achieve will be the first small company that Omnicom has supported in commercializing a newly approved drug. Therefore, Omnicom will take on a broader strategic role than in its past partnerships. The Omnicom team will help communicate the optimal message to the provider and patient and monitor its effectiveness in real time. This will allow for rapid course corrections and focus on high value activities. Achieve has identified several target groups for its marketing efforts that are stratified by age, social media use and other demographic data. It was able to identify these groups based on subject experiences in the company's many clinical trials. We anticipate that the structure of Achieve's internal marketing team will be heavily tilted toward supporting the digital campaign with contract representatives available for in-person physician meetings when appropriate. Public Offering On June 30th, 2025 Achieve closed its $45 million capital raise. 15 million shares were issued at $3.00, each of which included an attached warrant exercisable at $3.00 per share. An additional 1,766,666 warrants were issued upon the partial exercise by the underwriters of their option to purchase additional shares, bringing total issued warrants to approximately 16.8 million. Net proceeds from the capital raise are estimated to be $41.3 million as disclosed in the June 27th Form 8-K filing. ORCA-OL Safety Trial Achieve began 2025 by announcing that 300 participants had completed six months of treatment in the Ongoing Research of Cytisinicline for Addiction Program, Open Label (ORCA-OL) trial. The Data Safety Monitoring Committee (DSMC) identified no safety concerns as of this milestone allowing registrational filing with the FDA. As of May 2025, a third DSMC safety review was completed which also found no unexpected treatment-related adverse events. As of the first quarter reporting date, more than 100 subjects had completed one year of cytisinicline treatment. Furthermore, about 75% of the 479 (~360) individuals remained on treatment in the trial. We think that it is a material real-world positive that so many participants would remain on a smoking cessation product for that long a period suggesting that cytisinicline is well tolerated. This is particularly notable given the high discontinuation rates for Chantix and the associated unpleasant side effects such as nausea, headache, abnormal dreams and constipation.[1] Achieve expects to complete the one-year safety data package in the next few months and will submit this to the FDA by the 120-day safety review milestone. This should be around year-end 2025. Achieve expects that it will far exceed the 100-patient minimum required for one year of safety observations and could see as many as 300 patients with one year of exposure. Since one of the secondary endpoints is efficacy, this study should be able to show a wealth of data that can help providers use cytisinicline more effectively especially in chronic areas of disease such as Chronic Obstructive Pulmonary Disease (COPD) and cardiology. Milestones Development of cytisinicline product label for smoking cessation – 1H:25 Completion of six months of ORCA-OL safety data for 300 subjects – January 2025 Attendance at Oppenheimer Healthcare Life Sciences Conference, Virtual – February 2025 Attendance at Barclays Healthcare Conference, Miami – March 2025 Selection of 3rd party logistics partner – 2Q:25 NDA Submission – 2Q:25 FDA data submission from patients with twelve months of exposure to cytisinicline – 4Q:25 Launch of Phase III vaping trial – 1H:26 FDA target action date for cytisinicline NDA – 1H:26 Launch of cytisinicline – 3Q:26 SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer . ________________________ [1] Minian, N., et al. Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review. BMC Public Health. March 2024.
