Latest news with #JohnVandermosten
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.
Associated Press
25-02-2025
- Business
- Associated Press
Sigyn Therapeutics to be Featured in Fireside Chat With Zacks Healthcare Analyst
The Exclusive Event Kicks-Off Tomorrow February 26th at 4pm Eastern SAN DIEGO - February 25, 2025 ( NEWMEDIAWIRE) - Sigyn Therapeutics, Inc. ('Sigyn' or the 'Company') (OTCQB: SIGY), a developer of next-generation blood purification devices to treat cancer and life-threatening infectious disease disorders, disclosed today that Company CEO, Jim Joyce, will participate in a Fireside Chat tomorrow with Zacks Senior Healthcare Analyst, John Vandermosten. Zacks is a leading investment research firm focusing on stock research, analysis and recommendations. This exclusive event is being hosted by Force Family Office, the largest network of family offices in the United States with a substantial and growing presence internationally. The Fireside Chat will review the emergence of blood purification therapies to address life-threatening infectious disease conditions that are beyond the reach of drugs and additionally will discuss the development of devices to synergistically optimize the benefit of leading drugs to treat cancer. Event Details Date: February 26th Time: 4pm Eastern (1pm Pacific) Force Family Office Event Description Healthcare is driven by innovation. New discoveries, technologies, applications, molecules, devices, and formulations are at the heart of an industry that never stands still. Which are the experts watching? One of those is Sigyn Therapy, a blood purification therapy with applications in infectious disease, oncology, dialysis and organ transplantation. Register now to join this Fireside Chat with Zacks Senior Healthcare Analyst, John Vandermosten, and Jim Joyce, CEO of Sigyn Therapeutics, for a discussion of innovations on the horizon that will be creating value in the healthcare sector. About Sigyn Therapeutics(TM) Sigyn Therapeutics is developing next-generation blood purification therapies to address cancer and life-threatening infectious disease disorders that are not treatable with drugs. The Company's lead product candidate, Sigyn Therapy(TM) has been demonstrated to reduce the presence of viral pathogens, bacterial toxins, and pro-inflammatory cytokines from human blood plasma. Based on these capabilities, Sigyn Therapy(TM) is a candidate to treat life-threatening viral pathogens, antibiotic-resistant bacterial infections, endotoxemia, and sepsis, which is the leading cause of death in U.S. hospitals. The clinical protocol of first-in-human studies incorporates Sigyn Therapy with regularly scheduled dialysis treatments to address endotoxemia and concurrent inflammation, which are highly prevalent disorders that shorten the lives of end-stage renal disease (ESRD) patients. Extending the lives of those with ESRD could significantly impact dialysis industry revenues. The Company's oncology pipeline is comprised of ImmunePrep(TM), a platform to enhance the delivery of immunotherapeutic antibodies; ChemoPrep(TM) to improve the delivery of chemotherapeutic agents; and ChemoPure(TM) to reduce chemotherapy toxicity. If successfully advanced, the Company's therapies offer to provide strategic value to the dialysis and biopharmaceutical industry. CONTACTS: Sigyn Therapeutics, Inc. Johan Louw Senior Vice President of Strategic Programs 281.660.1815 [email protected] CEO, Inventor Cautionary Note Regarding Forward-Looking Statements This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. ('Sigyn') that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as 'may,' 'believe,' 'anticipate,' 'expect,' 'intend,' 'plan,' 'project,' 'will,' 'projections,' 'estimate,' 'potentially' or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company's ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company's ability to manufacture Sigyn Therapy, the Company's ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption 'Risk Factors' in the Company's Annual Report on Form 10-K, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
