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Yahoo
7 minutes ago
- 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.
Business Upturn
8 minutes ago
- Business Upturn
On Eve of Massive Spending Proposal, Resurfacing Presentation from Former Pentagon Advisor Suggests Untapped U.S. Asset Could Quietly Balance the Books
Washington, D.C., July 05, 2025 (GLOBE NEWSWIRE) — As President Trump prepares to introduce a sweeping legislative package—described by insiders as a 'Big Beautiful Bill' with trillion-dollar implications—a released presentation by former White House advisor Jim Rickards may offer a surprising counterbalance. According to Rickards, the U.S. already controls a little-known national asset capable of offsetting many of the bill's fiscal demands—without borrowing, taxing, or printing new dollars. 'The nature of this 'trust' as I call it, is such that politicians haven't been able to raid it… which has allowed it to grow untouched… for decades' . 'This is not some kind of government program like those COVID relief checks,' he adds. 'But it is a chance for the average American to become richer than they ever imagined' . A Resource Base Hidden in Plain Sight The presentation points to a vast store of natural resources—buried beneath federally owned land—stretching across the United States. These include copper, lithium, uranium, and other strategic minerals essential to infrastructure, defense, and energy systems. '$516 billion is here in the Salton Sea area of California… $3.1 trillion in Nome, Alaska. And $7.35 trillion in Midland, Texas…' . Rickards notes that these reserves have been known to government agencies for decades, but effectively off-limits due to environmental red tape and political inertia. 'For the past 50 years, fake-experts have strangled us from within the government,' he says. 'They tied us down with reams of regulation' . Trump's Pivot to Domestic Wealth With the introduction of this new bill—which some expect to prioritize military modernization, industrial revitalization, and energy security—Rickards believes the shift toward using domestic assets isn't just philosophical, it's practical. 'Trump is re-opening our mineral-rich Federal Lands. And fast-tracking companies that could recover trillions of dollars' worth of resources, right here in America'. 'There are certain areas where we have great, raw earth… and we're not allowed to use it because of the environment. I'm going to open them up,' Trump said . Decades of Delay. Days from Decision. The presentation references several high-value resource projects that have been stuck in limbo for years: 'Resolution Copper Mine… 29 years' 'Pebble Mine… since 1990' 'Thacker Pass Lithium Mine… since 1978' Now, Rickards says, the clock may finally be ticking in the other direction. 'We know exactly where these minerals are. We know they're worth trillions of dollars. And now—for the first time in half a century—we can go get them' . A New Path Forward? Rickards argues this isn't a question of what to create—but whether we'll finally use what's already ours. 'It's not earmarked for any specific individual,' he clarifies. 'I'm just trying to use terminology that will make the most sense to viewers' . 'We've had this rich endowment right under our feet… yet for years, we refused to touch it' . As Congress prepares for a new budget cycle, the presentation adds fuel to a growing conversation: Can America build the future… with what it already owns? About Jim Rickards Jim Rickards is a former advisor to the CIA, Pentagon, and U.S. Treasury. He played a key role in the Petrodollar Accord in the 1970s, has counseled the U.S. government through major financial and geopolitical events, and is the author of seven New York Times bestselling books. He now serves as a strategic analyst focused on national resilience, resource policy, and economic forecasting. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
10 minutes ago
- Yahoo
No Duh: Suze Orman on Why Parents Shouldn't Be Paying Their Adult Kids' Phone Bills
In one of the most famous — and funniest — scenes from the 2010s-era HBO comedy series 'Girls,' perpetually petulant slacker and aspiring 'voice of a generation' Hannah Horvath (Lena Dunham) sits across from her parents as they cut her off financially. While Hannah has spent hours at an unpaid internship, bopping around Brooklyn and discovering herself, Mom and Dad have been footing the bill for everything — including her phone. Up Next: For You: 'We can't keep bankrolling your groovy lifestyle,' Mom says, prompting Hannah to insist that she's so close to the life she wants, her parents shouldn't end it now. The scene resonates because it has played out thousands of times in households around the country. Suze Orman, personal finance expert and best-selling author, would likely support Hannah's parents in their choice to make her stand on her own two feet — even if she's generally more in favor of starting with small, gradual steps. In a recent LinkedIn post, Orman emphasized how important it is for parents to stop paying for even seemingly small expenses, like phone bills, to help their children become more financially independent. Orman understands why parents are so tempted to help young adults. After all, cell phone bills and streaming services seem like relatively minor expenses — so why not make your kids' lives easier by covering them? However, Orman urges parents to flip their perspective: If the amount is truly small, that's exactly why young adults should be paying it themselves. Learning to manage even modest bills helps build a strong financial foundation. 'If it's a manageable amount, it won't be hard for them to take on. And that's a key step toward financial independence,' Orman wrote. 'Maybe it's the first bill they put on auto-pay — helping them build responsible habits and a strong credit score. Every step counts on the road to financial freedom!' Learn More: Hannah's parents may have had the right idea, but forcing her into total financial independence without helping her establish a financial safety net first might not be the wisest approach. Orman isn't against parents offering some financial help to their adult children, but she believes it should be structured to help young adults develop financial skills. In addition to having young adults pay for their own phone bills, streaming services, and car insurance, Orman says that adult children who move back home should chip in toward household expenses. Parents don't need to charge their twentysomethings the equivalent of a full market-rate mortgage or rent payment — after all, if they could afford rent, they wouldn't be living at home — but getting them in the habit of budgeting a certain amount to make 'rent' each month helps instill financial discipline. If parents genuinely don't need the extra money, they can always set aside their child's 'rent payments' and later return the funds as the foundation for an emergency savings account. As your children become adults — goodness, where did the time go? — you're nearing the age where retirement planning becomes even more critical. To ensure your own future, you simply can't remain open as the Bank of Mom and Dad. Orman stresses that while parents should encourage their kids to build financial independence, they must also stay focused on their own financial goals — especially retirement. Think of it this way: You've worked hard to build your financial security, and just as your adult children are in their own self-discovery periods, you have the right to start one of your own. More From GOBankingRates 8 Common Mistakes Retirees Make With Their Social Security Checks This article originally appeared on No Duh: Suze Orman on Why Parents Shouldn't Be Paying Their Adult Kids' Phone Bills
