Achieve Life Sciences Inc Stock Price, News & Analysis

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.

Achieve Life Sciences (Nasdaq: ACHV) has been added to the U.S. Russell 3000® and Russell Microcap® Indexes, effective July 1, 2024. CEO John Bencich highlighted this as a step to enhance the company's visibility among investors, reflecting solid business fundamentals and market potential for cytisinicline, their treatment for nicotine dependence. Achieve plans to submit a new drug application for smoking cessation in the U.S. in the first half of 2025.

Additionally, Achieve has entered a non-binding term sheet with Silicon Valley Bank to refinance and extend the maturity date of its outstanding term loans. This facility could provide up to $20 million, with interest-only payments through December 31, 2025, maturing on June 1, 2028. The parties expect to close the refinanced loan by August 1, 2024, but there is no guarantee of a definitive agreement.

Achieve Life Sciences has initiated the ORCA-OL clinical trial to evaluate the long-term safety of cytisinicline, a treatment for smoking and nicotine dependence. The open-label trial involves 29 U.S. sites and aims to collect data required for a New Drug Application (NDA) submission expected in the first half of 2025. The study will focus on adults who smoke or use nicotine e-cigarettes, engaging prior ORCA trial participants. It will collect long-term safety data from at least 300 subjects over six months and 100 subjects over one year. Achieve aims to address the FDA's lack of approved treatments for vaping cessation.

Achieve Life Sciences (Nasdaq: ACHV) announced that data from their Phase 2 ORCA-V1 trial will be presented at the Society of General Internal Medicine (SGIM) Annual Meeting in Boston on May 17, 2024. The study, led by Dr. Nancy Rigotti of Harvard Medical School, demonstrated that cytisinicline treatment more than doubled the likelihood of quitting nicotine e-cigarettes compared to placebo. Dr. Rigotti's presentation will occur at 2:45 PM EDT during the 'SAN2: Scientific Abstract Oral Presentations in Mental/Behavioral Health and Substance Use' session. The study was supported by the NIH's National Institute on Drug Abuse.

Achieve Life Sciences, Inc. (NASDAQ: ACHV) reported Q1 2024 financial results, highlighted by positive Phase 2 trial results for cytisinicline in vaping cessation published in JAMA IM, plans to initiate a long-term safety exposure trial, and successful presentations at medical conferences. The company also secured approximately $124.2 million in equity financing to support ongoing clinical development activities. Achieve's cash position stood at $66.4 million as of March 31, 2024, with total operating expenses at $6.0 million and a net loss of $6.5 million for the quarter.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced the publication of ORCA-V1 trial results in JAMA Internal Medicine. The trial showed that treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo, with excellent compliance and safety. Achieve plans to conduct an End-of-Phase 2 Meeting with the FDA to discuss Phase 3 trial plans.