Welcome to our dedicated page for Achieve Life Sciences news (Ticker: ACHV), a resource for investors and traders seeking the latest updates and insights on Achieve Life Sciences stock.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. The ACHV news feed highlights company announcements related to its cytisinicline program for smoking cessation in adults and for nicotine e-cigarette or vaping cessation.
News items from Achieve commonly cover clinical and regulatory milestones for cytisinicline, including the acceptance of its New Drug Application by the U.S. Food and Drug Administration (FDA) for smoking cessation, assignment of a Prescription Drug User Fee Act (PDUFA) target action date, and progress in long-term safety trials such as ORCA-OL. Releases also describe Phase 3 efficacy data from ORCA-2 and ORCA-3, Phase 2 results in vaping cessation (ORCA-V1), and post hoc analyses in specific populations such as individuals with chronic obstructive pulmonary disease (COPD).
Investors and observers can use the ACHV news page to follow regulatory designations and programs cited by the company, including Breakthrough Therapy designation for nicotine e-cigarette or vaping cessation and the Commissioner’s National Priority Voucher awarded for cytisinicline. Additional news topics include executive appointments, equity inducement awards, financing transactions disclosed in conjunction with SEC filings, and scheduling of earnings calls and investor meetings.
This page provides a centralized view of Achieve’s press releases and related updates, offering context on how the company describes its progress in advancing cytisinicline as an investigational treatment of nicotine dependence. For those tracking ACHV stock or the development of cytisinicline, the news feed can be revisited regularly to see new clinical, regulatory, and corporate disclosures as they are issued by the company.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment, will release its third quarter 2024 financial results and provide a corporate update on November 7, 2024, at 4:30 PM EST. The company will host a conference call and webcast accessible via phone or online streaming. The webcast replay will be available approximately three hours after the call and remain archived on the website for 90 days.
Achieve Life Sciences (Nasdaq: ACHV) announced Dr. Cindy Jacobs' presentation at the FDA and NIH Joint Public Meeting on advancing smoking cessation treatments. Dr. Jacobs highlighted cytisinicline, the only nicotine dependence treatment currently in late-stage development. The company has completed two Phase 3 trials involving over 1,600 subjects, demonstrating safety and efficacy. The new formulation features a streamlined dosing schedule and extended treatment durations, improving upon the complex 25-day regimen of the original cytisine treatment used in Eastern and Central Europe. Achieve is working on completing a longer-term safety exposure study before NDA filing.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has promoted Jaime Xinos to Chief Commercial Officer, effective immediately. In her expanded role, Ms. Xinos will oversee all commercial operations and lead the company's strategic preparations for the anticipated U.S. launch of cytisinicline, a treatment for nicotine dependence. Her responsibilities include driving readiness across key stakeholders, including patients, healthcare providers, and payors.
Ms. Xinos, who has been with Achieve since 2017, will focus on developing innovative, patient-first, digital strategies and forging strategic partnerships to ensure a successful market entry for cytisinicline upon FDA approval. With nearly 25 years of commercial experience in the biotechnology and pharmaceutical industries, Ms. Xinos is recognized as an inspirational thought leader in translating scientific advancements into business strategies.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has appointed Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings over 20 years of experience in clinical medicine, scientific research, and medical affairs leadership, with a focus on preventative medicine and nicotine cessation. His expertise aligns with Achieve's mission to provide innovative solutions for nicotine dependence.
Dr. Rubinstein previously served as Head of Medical Affairs at Blip and Vice President of Global Scientific Affairs at Juul Labs. He is Professor Emeritus of Pediatrics at the University of California, San Francisco (UCSF), where he conducted NIH-funded research on nicotine addiction in adolescents and smoking cessation interventions. Dr. Rubinstein's appointment comes as Achieve moves closer to anticipated FDA approval and commercialization of cytisinicline, potentially the first new treatment for nicotine dependence in nearly 20 years.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced significant changes in its executive leadership and Board of Directors. Richard Stewart, co-founder and current Executive Chairman, will reassume the role of Chief Executive Officer, replacing John Bencich, who served as CEO for the past four years. Thomas King, currently the lead independent director, will assume the role of Executive Chairman.
The leadership change is aimed at bringing in a CEO with substantial M&A and commercial experience to drive the company towards critical milestones, including potential licensing or strategic transactions for the commercialization of cytisinicline, their smoking cessation and nicotine dependence treatment. Achieve remains on track to meet its objectives, including completing enrollment for the ORCA-OL study, meeting with the FDA for an End-of-Phase 2 meeting for vaping cessation, and progressing towards an NDA submission expected in the first half of 2025.
Achieve Life Sciences (NASDAQ: ACHV) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. FDA granted Breakthrough Therapy designation for cytisinicline for vaping cessation
2. Completed refinancing with Silicon Valley Bank, extending loan maturity to December 2027
3. Joined Russell 3000® and Russell Microcap® Indexes
4. Initiated ORCA-OL trial for long-term cytisinicline exposure
5. Presented ORCA-V1 vaping cessation data at SGIM Annual Meeting
Financial results: Cash position of $61.3 million as of June 30, 2024. Q2 operating expenses were $8.4 million with a net loss of $8.5 million. The company expects to file an NDA for cytisinicline in H1 2025.
Achieve Life Sciences (Nasdaq: ACHV) has received FDA Breakthrough Therapy Designation for cytisinicline, a potential first-in-class treatment for nicotine e-cigarette and vaping cessation. This designation is based on the Phase 2 ORCA-V1 trial results, which showed that cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo. The trial, published in JAMA Internal Medicine, involved 160 adults and demonstrated that participants treated with cytisinicline were 2.6 times more likely to quit vaping. The treatment was well-tolerated with no serious adverse events reported. Achieve plans to hold an End-of-Phase 2 meeting with the FDA before year-end to expedite development and review of cytisinicline for this serious condition affecting over 13 million people in the US.
Achieve Life Sciences (Nasdaq: ACHV) has secured a $20 million debt refinancing agreement with Silicon Valley Bank (SVB). This deal refinances existing debt and extends the maturity date to December 1, 2027. The loan is structured in three tranches: $10 million at closing, $5 million upon FDA acceptance of the New Drug Application for cytisinicline, and $5 million at SVB's discretion. Key terms include:
- Interest rate: Greater of 7.0% or prime rate minus 1.0%
- Interest-only period through December 31, 2025
- Option to convert debt to common stock at $7.00 per share
- Potential six-month extension based on milestones
This refinancing aims to lower capital costs, extend cash runway, and support cytisinicline's regulatory approval process.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing cytisinicline for smoking cessation and nicotine dependence, has announced it will report its second quarter 2024 financial results on August 13, 2024, at 4:30 PM EDT. The company will also provide an update on the cytisinicline development program during the call.
Investors and interested parties can access the webcast through a provided link or join the live conference call by dialing specific numbers for U.S. & Canada or International callers. The conference ID is 13747337. A replay of the webcast will be available approximately three hours after the call and will be archived on the company's website for 90 days.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company specializing in cytisinicline for smoking cessation and nicotine dependence, announced its participation in the JonesHealthcare Seaside Summit 2024. The event will take place from July 14-16, 2024, in Encinitas, CA. CEO John Bencich is scheduled to present on July 15, 2024, at 8:45 AM PDT. Following his presentation, Bencich will join a live panel discussion, "Introducing Disruptive Products to Established Healthcare Markets—Commercial and Regulatory Considerations," at 10:00 AM PDT, moderated by Justin Walsh, PhD, Healthcare Research Analyst at JonesTrading Institutional Services. For more information or to arrange one-on-one meetings, contact JonesTrading or visit Achieve Life Sciences' Investor Relations website.