| Achieve Life Sciences, Inc. (ACHV) Q1 2025 Earnings Call Transcript |
Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q1 2025 Earnings Conference Call May 13, 2025 8:30 AM ET Company Participants Nicole Jones - Investor Relations Rick Stewart - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Mark Oki - Chief Financial Officer Jaime Xinos - Chief Commercial Officer Conference Call Participants Gary Nachman - Raymond James Justin Walsh - Jones Trading John Vandermosten - Zacks Investment Research Operator Greetings. Welcome to Achieve Life Sciences First Quarter 2025 Earnings Conference Call and Webcast. |
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2025-05-13 16:16:12 |
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| Achieve Life Sciences Reports First Quarter 2025 Financial Results and Highlights Updates in Cytisinicline Program |
Reiterates Planned Submission of an NDA for Cytisinicline to FDA in June 2025 Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, May 13, 2025 SEATTLE and VANCOUVER, British Columbia, May 13, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced its financial results for first quarter 2025 and confirmed that it plans to submit the upcoming New Drug Application (NDA) for cytisinicline to the U.S. Food and Drug Administration (FDA) in June 2025. “The Achieve team is fully committed to finalizing the NDA for submission to the FDA next month. |
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2025-05-13 11:30:00 |
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| Achieve Life Sciences to Announce First Quarter 2025 Financial Results and Host Conference Call and Webcast on May 13, 2025 |
SEATTLE and VANCOUVER, British Columbia, May 06, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV) a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced that it will report its first quarter 2025 financial results and provide a corporate update on the cytisinicline development program on Tuesday May 13, 2025, at 8:30 AM EDT. |
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2025-05-06 12:30:00 |
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| Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine |
ORCA-3 Demonstrated a Significant Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo |
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2025-04-21 15:19:00 |
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| Achieve Life Sciences, Inc. (ACHV) Q4 2024 Earnings Call Transcript |
Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q4 2024 Earnings Conference Call March 11, 2025 8:30 AM ET Company Participants Nicole Jones - IR Richard Stewart - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jaime Xinos - Chief Commercial Officer Mark Oki - Chief Financial Officer Conference Call Participants Gary Nachman - Raymond James Thomas Flaten - Lake Street Capital Markets Francois Brisebois - Oppenheimer and Company Justin Walsh - Jones Trading Brandon Folkes - Rodman & Renshaw John Vandermosten - Zacks SCR Boris Tolkachev - Freedom Broker Operator Greetings, and welcome to the Achieve Life Sciences Fourth Quarter and Year-End 2024 Earnings Call and Webcast. At this time all participants are in a listen-only mode. |
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2025-03-11 16:52:39 |
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| Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2024 and Provides Update on the Cytisinicline Development Program |
Reiterates Planned Cytisinicline NDA Submission Expected at the End of Q2 2025 Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, March 11, 2025 SEATTLE and VANCOUVER, British Columbia, March 11, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced its financial results for the fourth quarter and year-end 2024 and reiterated its plans to submit its new drug application (NDA) for cytisinicline at the end of the second quarter of 2025. Recent Highlights Reached key milestones in the ORCA-OL long-term exposure trial, including completion of enrollment and meeting the requirement of 300 participants receiving six months of cumulative cytisinicline treatment, as required for the submission of the NDA Announced positive outcomes from two data safety monitoring committee (DSMC) reviews with no safety concerns in the ORCA-OL clinical trial Appointed Dr. Kristen Slaoui and Nancy Phelan to the Board of Directors, bringing extensive leadership experience in corporate strategy and commercialization Appointed Mark Oki as Chief Financial Officer to oversee the company's financial strategy and operational initiatives Announced the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for defining cytisinicline development as a treatment for vaping cessation “We are thrilled with our progress to date and excited to have the NDA submission on track for the end of next quarter, furthering our mission to bring cytisinicline to market as the first new FDA-approved nicotine dependence treatment in nearly 20 years,” said Rick Stewart, Achieve's Chief Executive Officer. |
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2025-03-11 09:30:00 |
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| Achieve Life Sciences to Present at the Barclays 27th Annual Global Healthcare Conference |
SEATTLE and VANCOUVER, British Columbia, March 07, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced that the company will be presenting at the Barclays 27th Annual Global Healthcare Conference to be held March 11-13, 2025, in Miami, FL. |
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2025-03-07 10:30:00 |
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| Achieve Life Sciences to Announce Fourth Quarter and Year-End 2024 Financial Results and Host Conference Call and Webcast on March 11, 2025 |
SEATTLE and VANCOUVER, British Columbia, March 06, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced it will report its fourth quarter and year-end 2024 financial results and provide an update on the cytisinicline development program on Tuesday, March 11, 2025, at 8:30 AM EDT. |
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2025-03-06 10:30:00 |
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| Achieve Life Sciences to Present at the Oppenheimer Healthcare Life Sciences Conference |
SEATTLE and VANCOUVER, British Columbia, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Rick Stewart, Chief Executive Officer of Achieve, will be presenting today at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11, 2025, at 10:00 a.m. EST. |
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2025-02-11 10:30:00 |
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| Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial |
No Safety Concerns Identified by DSMC in the ORCA-OL Long-Term Exposure Trial Achieve Reiterates Planned Cytisinicline NDA Submission in Q2 2025 SEATTLE and VANCOUVER, British Columbia, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that the Data Safety Monitoring Committee (DSMC) has recently completed its second independent review of the ongoing ORCA-OL trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine. Following this second comprehensive review of available safety data, the DSMC stated that it did not identify any unexpected treatment-related adverse events and that the participants' adherence to their cytisinicline medication was excellent. |
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2025-02-10 10:30:00 |
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| Achieve Life Sciences Appoints Dr. Kristen Slaoui and Nancy Phelan to its Board of Directors |
New Directors Bring Extensive Leadership Experience in Corporate Strategy and Commercialization New Directors Bring Extensive Leadership Experience in Corporate Strategy and Commercialization |
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2025-01-10 10:30:00 |
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| Achieve Life Sciences Announces Critical Milestone Successfully Reached in ORCA-OL Cytisinicline Clinical Trial Required for NDA Submission |
Over 300 Participants Have Completed Cumulative Six Months of Cytisinicline Treatment in the ORCA-OL Trial, Completing the Long-Term Exposure Requirement for NDA Submission |
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2025-01-07 10:30:00 |
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| Achieve Life Sciences to Host Meetings During the J.P. Morgan Healthcare Conference Week |
SEATTLE and VANCOUVER, British Columbia, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for nicotine dependence, announced today that the company will be hosting in-person one-on-one meetings coinciding with the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, January 13-16, 2025. |
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2025-01-06 10:30:00 |
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| Achieve Life Sciences Appoints Mark Oki as Chief Financial Officer |
SEATTLE and VANCOUVER, British Columbia, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, today announced that Mark Oki has joined the company as its Chief Financial Officer, effective December 5, 2024. Mr. Oki will oversee the company's financial strategy and operations, including accounting, investor relations, information technology, legal and other key administrative functions, ensuring effective planning and execution to support organizational objectives. |
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2024-12-09 10:30:00 |
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| Achieve Life Sciences to Advance First Vaping Cessation Therapy After Successful End-of-Phase 2 Meeting with FDA |
Milestone Reinforces the Potential for Cytisinicline as a First-in-Class Treatment for Vaping Cessation Milestone Reinforces the Potential for Cytisinicline as a First-in-Class Treatment for Vaping Cessation |
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2024-12-03 10:30:00 |
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| Smoking Cessation Pipeline Insight 2024, with Focus on Emerging Drugs Cytisinicline (Achieve Life Sciences), EMB-001(Embera Pharmaceuticals) and SBP-9330 (Camino Pharma) |
Coverage of pipeline drug profiles, including clinical and nonclinical stage products and therapeutics assessment by product type, stage, route of administration, and molecule type. Coverage of pipeline drug profiles, including clinical and nonclinical stage products and therapeutics assessment by product type, stage, route of administration, and molecule type. |
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2024-11-25 09:54:00 |
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| Achieve Life Sciences Announces Participation at Upcoming Investor Conferences |
SEATTLE and VANCOUVER, British Columbia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, today announced that Rick Stewart, CEO of Achieve Life Sciences, and management will be participating at two upcoming investor conferences. |
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2024-11-14 10:30:00 |
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| Achieve Life Sciences, Inc. (ACHV) Q3 2024 Earnings Call Transcript |
Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q3 2024 Earnings Conference Call November 7, 2024 4:30 PM ET Company Participants Nicole Jones - IR Richard Stewart - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Jaime Xinos - Chief Commercial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Justin Walsh - JonesTrading John Vandermosten - Zacks Small-Cap Research Gary Nachman - Raymond James Boris Tolkachev - Freedom Broker Operator Greetings, and welcome to the Achieve Life Sciences Third Quarter 2024 Earnings Conference Call and Webcast. [Operator Instructions] And as a reminder, this conference is being recorded. |
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2024-11-09 09:32:34 |
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| Achieve Life Sciences President and CMO, Dr. Cindy Jacobs, Speaks at FDA and NIH Smoking Cessation Public Meeting |
SEATTLE and VANCOUVER, British Columbia, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, announced that Dr. Cindy Jacobs, Achieve's President and Chief Medical Officer, presented at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) Joint Public Meeting on “Advancing Smoking Cessation: FDA and NIH Priorities” held on October 21, 2024. |
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2024-10-23 12:00:00 |
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| Achieve Life Sciences Promotes Jaime Xinos to Chief Commercial Officer to Advance Commercial Readiness of Cytisinicline |
SEATTLE and VANCOUVER, British Columbia, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, is pleased to announce the promotion of Ms. Jaime Xinos to Chief Commercial Officer, effective immediately. |
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2024-10-16 12:00:00 |
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| Achieve Life Sciences Strengthens Leadership with Appointment of Dr. Mark Rubinstein, Nicotine Dependence Expert, as New Head of Medical Affairs |
SEATTLE and VANCOUVER, British Columbia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, is pleased to announce the appointment of Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings more than two decades of experience in clinical medicine, scientific research, and medical affairs leadership, with a strong focus on preventative medicine and nicotine cessation. |
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2024-10-01 12:45:00 |
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| Achieve Life Sciences Announces Changes in Executive Leadership and Board of Directors |
Richard Stewart reassumes role of Chief Executive Officer Thomas King appointed Executive Chairman of the Board of Directors SEATTLE and VANCOUVER, British Columbia, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Mr. Richard (Rick) Stewart, Achieve's co-founder and current Executive Chairman, will reassume the role of Chief Executive Officer. |
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2024-08-26 20:30:00 |
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| Achieve Life Sciences, Inc. (ACHV) Q2 2024 Earnings Call Transcript |
Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Nicole Jones - IR John Bencich - CEO Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Justin Walsh - JonesTrading John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Thomas Flaten - Lake Street Capital Operator Greetings, and welcome to the Achieve Life Sciences Second Quarter 2024 Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. |
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2024-08-14 08:58:09 |
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| Achieve Life Sciences Reports Financial Results for Second Quarter 2024 and Provides Corporate Update |
Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024 Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024 |
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2024-08-13 20:01:00 |
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| Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence |
Designation is based on results from the Phase 2 ORCA-V1 trial that showed treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo Designation is based on results from the Phase 2 ORCA-V1 trial that showed treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo |
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2024-07-31 12:00:00 |
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| Achieve Life Sciences Announces $20M Loan Refinancing with Silicon Valley Bank |
SEATTLE and VANCOUVER, British Columbia, July 29, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has entered into a $20 million debt refinancing agreement with Silicon Valley Bank (SVB), a division of First-Citizens Bank. The new loan agreement refinances the existing debt facility with SVB and SVB Capital and extends the maturity date from August 1, 2024 to December 1, 2027. |
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2024-07-29 12:00:00 |
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| Achieve Life Sciences to Announce Second Quarter Financial Results and Host Conference Call and Webcast on August 13, 2024 |
SEATTLE and VANCOUVER, British Columbia, July 25, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its second quarter 2024 financial results and provide an update on the cytisinicline development program on Tuesday, August 13, 2024, at 4:30 PM EDT. |
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2024-07-25 12:00:00 |
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| Achieve Life Sciences to Present at JonesHealthcare Seaside Summit 2024 |
SEATTLE and VANCOUVER, British Columbia, July 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Achieve management will be attending the JonesHealthcare Seaside Summit 2024 being held July 14-16, 2024, in Encinitas, CA. |
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2024-07-09 12:00:00 |
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| Achieve Life Sciences: 1st Half 2025 NDA Filing On Track With FDA Agreement |
Achieve Life Sciences, Inc. initiated an open-label ORCA-OL trial using cytisinicline for smoking cessation; the Efficacy of the drug already established in several prior studies. Alignment with FDA that successful completion of ORCA-OL trial is necessary for NDA filing of cytisinicline in the 1st half of 2025. The global smoking cessation product market is estimated to reach $69.8 billion by the end of 2034. |
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2024-07-01 17:46:15 |
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| Achieve Life Sciences Announces Data from Cytisinicline ORCA-V1 Program to be Presented at Society of General Internal Medicine (SGIM) Annual Meeting |
SEATTLE and VANCOUVER, British Columbia, May 17, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced data from the Phase 2 ORCA-V1 vaping cessation trial will be presented today, Friday, May 17, 2024, at the Society of General Internal Medicine (SGIM) Annual Meeting being held in Boston, MA. |
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2024-05-17 12:00:00 |
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| Achieve Life Sciences, Inc. (ACHV) Q1 2024 Earnings Call Transcript |
Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Nicole Jones - Investor Relations John Bencich - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Michael Higgins - Ladenburg Thalmann John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Operator Greetings. Welcome to Achieve Life Sciences' First Quarter 2024 Earnings Conference Call and Webcast. |
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2024-05-09 23:58:06 |
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| Achieve Life Sciences Reports Financial Results for First Quarter 2024 and Provides Corporate Update |
Company to host conference call at 4:30 PM EDT today, Thursday, May 9, 2024 Company to host conference call at 4:30 PM EDT today, Thursday, May 9, 2024 |
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2024-05-09 20:01:00 |
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| Achieve Life Sciences Announces Publication of Cytisinicline Vaping Cessation Trial Results in JAMA Internal Medicine |
Phase 2 ORCA-V1 trial showed treatment with cytisinicline more than doubled odds of quitting e-cigarettes compared with placebo |
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2024-05-06 15:16:00 |
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