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 (NASDAQ: ACHV) generates news driven by its position as a clinical-stage pharmaceutical company developing cytisine for smoking cessation. As a single-asset biotech pursuing FDA approval, the company's news flow centers on regulatory milestones, clinical trial developments, and corporate financing activities that directly impact its path to commercialization.
The company's news typically includes FDA interactions and regulatory submissions, clinical trial results and study updates, patent grants protecting its intellectual property, executive appointments and leadership changes, and quarterly financial reports detailing cash runway and operational progress. Each regulatory milestone or setback carries significant weight for investors monitoring ACHV's development timeline.
Achieve Life Sciences' focus on nicotine addiction treatment places its news within the broader context of public health initiatives and smoking cessation research. News items often reference the company's clinical data, its engagement with the FDA, and strategic decisions regarding partnerships or capital allocation. The specialty pharmaceutical sector generates distinct news patterns compared to diversified healthcare companies, with material announcements typically tied to specific development catalysts rather than quarterly revenue fluctuations.
Bookmark this page to follow ACHV's regulatory progress, clinical announcements, and corporate developments as the company advances cytisine toward potential FDA approval and commercial launch.
Achieve Life Sciences (NASDAQ: ACHV) has submitted a New Drug Application (NDA) to the FDA for cytisinicline, a novel treatment for nicotine dependence in adult smoking cessation. If approved, cytisinicline would become the first new FDA-approved pharmacotherapy for nicotine dependence in 20 years.
The NDA submission is supported by data from two Phase 3 trials (ORCA-2 and ORCA-3), involving over 2,000 clinical trial participants. Both studies demonstrated significantly higher abstinence rates with cytisinicline compared to placebo at both 6 and 12-week treatment durations. Additional safety data from the ORCA-OL long-term trial, involving over 300 participants with six months of exposure, showed no new safety concerns.
Achieve Life Sciences (NASDAQ: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence and smoking cessation, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The conference will take place from June 3-5, 2025, in New York City. CEO Rick Stewart will deliver a presentation on Wednesday, June 4, 2025, at 5:30 PM EDT. Investors can access both the live webcast and replay of the presentation through the company's Investor Relations website.
Achieve Life Sciences (NASDAQ: ACHV) will present new data from its Phase 3 ORCA-3 study of cytisinicline at the 2025 ATS International Conference. The data demonstrates that cytisinicline significantly reduced nicotine cravings and intake, even in participants who didn't completely quit smoking. The drug's dual mechanism as a selective partial agonist and antagonist showed significant reductions in craving scores (p=0.0001) and decreased cotinine levels nearly four times more compared to placebo - equivalent to reducing consumption by about a pack per week.
The company plans to submit its New Drug Application next month. The treatment showed promising results for the general smoking population and particularly high quit rates among COPD patients in Phase 3 trials. If approved, cytisinicline could help address smoking cessation needs for approximately 29 million U.S. adults who continue to smoke.
Achieve Life Sciences (NASDAQ: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation, has scheduled its first quarter 2025 financial results announcement and corporate update for May 13, 2025, at 8:30 AM EDT. The company will provide updates on their cytisinicline development program during the call.
Investors can access the webcast through the provided link or join via phone by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) using conference ID 13752599. A replay will be available approximately three hours after the call and remain accessible on the website for 90 days.
Achieve Life Sciences (NASDAQ: ACHV) has published complete results of its ORCA-3 Phase 3 trial in JAMA Internal Medicine, evaluating cytisinicline for smoking cessation. The trial, involving 792 U.S. adults, demonstrated significant efficacy in both 6- and 12-week treatment durations.
The study showed that cytisinicline effectively increased quit rates and reduced nicotine cravings through 24 weeks. Trial participants averaged 53 years old, smoked 20 cigarettes daily, with a 36-year smoking history and four prior quit attempts. The drug's selective targeting of nicotine receptors resulted in better tolerability compared to existing treatments.
The company plans to submit a New Drug Application (NDA) to the FDA in June 2025.
Achieve Life Sciences (NASDAQ: ACHV) has announced its Q4 and year-end 2024 financial results, reaffirming plans to submit its New Drug Application (NDA) for cytisinicline by end of Q2 2025. The company reached key milestones in its ORCA-OL long-term exposure trial, including completing enrollment of 479 participants and meeting the FDA requirement of 300 participants receiving six months of cytisinicline treatment.
The company reported positive safety reviews from two Data Safety Monitoring Committee assessments of the ORCA-OL trial. Financial results show cash, equivalents, and marketable securities of $34.4 million as of December 31, 2024. Operating expenses were $12.2 million for Q4 and $39.1 million for the full year, with net losses of $12.4 million and $39.8 million respectively.
Additionally, Achieve received FDA agreement that one Phase 3 trial (ORCA-V2) would be acceptable for a vaping cessation indication as a supplemental NDA, with plans to initiate this trial in H1 2026, subject to funding availability.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation, has announced its participation in the Barclays 27th Annual Global Healthcare Conference. The conference will take place from March 11-13, 2025, in Miami, FL.
CEO Rick Stewart will deliver a presentation on Wednesday, March 12, 2025, at 11:30 AM EDT. Investors and interested parties can access both the live webcast and replay of the presentation through the Investor section of the company's website.
Achieve Life Sciences (NASDAQ: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation, has scheduled its fourth quarter and year-end 2024 financial results announcement for March 11, 2025, at 8:30 AM EDT. The company will also provide updates on its cytisinicline development program during the presentation.
Investors and interested parties can access the webcast through the 4Q24 Webcast link or join via telephone by dialing 877-269-7756 (U.S. & Canada) or 1-201-689-7817 (International) using conference ID 13751745. A replay of the webcast will be available approximately three hours after the call and remain accessible on the website for 90 days.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage specialty pharmaceutical company specializing in cytisinicline for smoking cessation and nicotine dependence, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference.
CEO Rick Stewart will deliver a presentation at the virtual conference on February 11, 2025, at 10:00 a.m. EST. Interested parties can access more information through their banking representatives or by visiting the company's Investor Relations website.
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