Achieve Life Sciences Nears FDA Filing for Novel Smoking Cessation Drug Following Successful Trials
Achieve Life Sciences is preparing to submit its breakthrough smoking cessation therapy cytisinicline for FDA approval following successful clinical trials. The plant-derived treatment, which received FDA breakthrough therapy designation for vaping cessation in 2024, could potentially capture a significant share of the $1 billion nicotine cessation market.
Achieve Life Sciences' Cytisinicline Meets NDA Requirements in ORCA-OL Trial
• Achieve Life Sciences' ORCA-OL trial met the FDA's requirement of at least 300 participants completing six months of cytisinicline treatment, a key milestone for NDA submission.
• The Data Safety Monitoring Committee found no safety concerns, allowing the ORCA-OL trial to proceed without modifications, reinforcing cytisinicline's safety profile.
• Achieve Life Sciences remains on track to submit its New Drug Application for cytisinicline in Q2 2025, potentially offering a novel treatment for nicotine dependence.
• Cytisinicline has Breakthrough Therapy designation for vaping cessation, addressing a critical need with no FDA-approved treatments currently available.
Achieve Life Sciences Advances Cytisinicline for Vaping Cessation with FDA Agreement
• Achieve Life Sciences received FDA agreement on its Phase 3 trial design for cytisinicline as a vaping cessation treatment.
• The FDA indicated that one Phase 3 trial (ORCA-V2), along with the Phase 2 ORCA-V1 trial, is sufficient for approval.
• The ORCA-V2 trial will evaluate 3 mg of cytisinicline three times daily versus placebo in approximately 800 adult e-cigarette users.
• With 60% of 11 million U.S. adult vapers wanting to quit, cytisinicline addresses a significant unmet need.
Achieve Life Sciences' Vaping Addiction Treatment Shows Promise, Attracts Bullish Forecasts
• Achieve Life Sciences is developing cytisinicline, a novel treatment for vaping addiction, which has received "breakthrough therapy" designation from the FDA.
• Zacks Small-Cap Research has set a price target of $30 per share for Achieve, citing significant developments in the company's business and clinical trials.
• The FDA has requested additional safety data on long-term cytisinicline use, potentially delaying regulatory approval until the third quarter of 2026.
• Cytisinicline, derived from plants, is undergoing testing in adults, with potential expansion to adolescents in 2025 pending FDA approval.
Achieve Life Sciences Completes Enrollment in Phase 3 ORCA-OL Trial for Cytisinicline
• Achieve Life Sciences completed enrollment in its Phase 3 ORCA-OL trial, evaluating cytisinicline for smoking and vaping cessation, with 479 participants across 29 U.S. sites.
• The FDA granted Breakthrough Therapy designation to cytisinicline for nicotine e-cigarette cessation, expediting its development and review.
• Achieve remains on track for planned NDA submission in the second quarter of 2025, driven by the potential to address the urgent need for effective smoking and vaping cessation solutions.
• Recent leadership appointments at Achieve underscore a commitment to strategic growth and maximizing shareholder value.
Achieve Life Sciences Completes Enrollment in ORCA-OL Trial and Receives FDA Breakthrough Therapy Designation for Cytisinicline
• Achieve Life Sciences completed enrollment in the Phase 3 ORCA-OL trial, evaluating the long-term safety of cytisinicline for smoking and vaping cessation, with positive initial safety review.
• The FDA granted Breakthrough Therapy designation to cytisinicline for nicotine e-cigarette cessation, potentially expediting its development and review process.
• Achieve is preparing for a planned NDA submission in Q2 2025, supported by a dedicated U.S. product launch team and strengthened leadership.
• Financial results for Q3 2024 show cash reserves of $42.9 million, with operating expenses of $12.5 million, positioning the company for continued advancement of cytisinicline.
Rapport Therapeutics Gains Buy Recommendation Based on RAP Platform and RAP-219 Potential
• Rapport Therapeutics receives a Buy rating from JonesTrading, driven by its innovative RAP platform targeting central nervous system disorders.
• RAP-219, Rapport's lead candidate, shows promise for treating epilepsy, pain, and bipolar disorder by targeting TARPγ8, with Phase II trials planned for 2025.
• Integration of NeuroPace's RNS device could enhance clinical proof of concept for RAP-219, improving patient recruitment and trial outcomes.
• Strategic focus on selective targeting aims to minimize side effects, potentially positioning RAP-219 as a best-in-class treatment.
Achieve Life Sciences Completes Enrollment in ORCA-OL Trial for Cytisinicline
• Achieve Life Sciences completed enrollment in the ORCA-OL trial, with 479 participants evaluating long-term exposure to cytisinicline for nicotine dependence.
• The Data Safety Monitoring Committee (DSMC) review found no safety concerns, allowing the trial to proceed without modifications, supporting cytisinicline's safety profile.
• Achieve plans to file a New Drug Application (NDA) for cytisinicline in the first half of 2025, aiming to provide a new smoking cessation treatment.
• Cytisinicline received FDA Breakthrough Therapy Designation for e-cigarette dependence, with plans to discuss further evaluation with the FDA.
Lack of Approved Therapies Highlights Challenges in Vaping Cessation
• E-cigarettes, initially seen as a smoking cessation tool, have led to a new wave of nicotine addiction, with many users finding it difficult to quit vaping.
• The FDA has not approved e-cigarettes for smoking cessation, and there is a lack of data on effective methods to stop vaping, creating a significant unmet need.
• Achieve Life Sciences is developing cytisinicline, a potential first-in-class medication for vaping cessation, which has received Breakthrough Therapy designation from the FDA.
• Alternative methods like nicotine pouches are being used to wean off vaping, but experts advise a short-term approach to avoid prolonged nicotine dependence.
Cytisine Faces FDA Delay Despite Global Success in Smoking Cessation
• Cytisine, a plant-based smoking cessation treatment approved in Canada and the UK, is awaiting FDA approval in the U.S.
• Clinical trials show cytisine is more effective than nicotine patches and gum, with fewer side effects than other drugs.
• The FDA's request for additional safety data has delayed potential U.S. approval by at least a year, impacting thousands of smokers.
• Researchers estimate cytisine could help over 70,000 Americans quit smoking each year if available in the U.S.
Achieve Life Sciences Plans Stock Offering to Advance Vaping Addiction Drug
• Achieve Life Sciences intends to raise up to $50 million through a stock offering, with Jefferies acting as the sales agent, to fund the clinical development of cytisinicline.
• The FDA granted Achieve's cytisinicline 'breakthrough therapy' designation, potentially accelerating its path to market, but requested additional safety data, possibly delaying approval until 2026.
• Achieve's stock price experienced volatility, initially gaining 7.4% before falling 3.6% in after-hours trading following the announcement of the stock offering.
• Analysts covering Achieve Life Sciences recommend a buy, with an average target price of $16.29 per share, suggesting a substantial upside from the recent closing price.
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