Achieve Life Sciences Azioni (NASDAQ: ACHV)

Ultime notizie per Achieve Life Sciences (NASDAQ:ACHV) Azioni

Achieve Life Sciences

Achieve Life Sciences Inc is a specialty pharmaceutical company committed to advancing cytisinicline as a widely available treatment option to help people battling nicotine addiction. It is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe. Achieve's focus is to address the smoking health epidemic through the development and commercialization of cytisinicline. It has one operating segment, dedicated to the development and commercialization of cytisinicline for niceon.

Achieve Life Sciences, Inc. - Common Shares

Achieve Life Sciences Inc

ORCA-3 Demonstrated a Significant Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo
Cytisinicline New Drug Application (NDA) Submission to FDA Planned for June 2025
SEATTLE and VANCOUVER, British Columbia, April 21, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>), 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 complete trial results from its ORCA-3 were published in the <a href="https://www.globenewswire.com/Tracker?data=AzbFrMUa4qC2IbEBD16NY2rJNGxPwdX0O0sSNUXm_aDNy28vyLWeW_-LrD35xDfNniKB7qenEIsDHhVOfNuzgqQBT5PhwPzigaGEAXCbGA0oMoKEGoLFcazCYGG_M0etUoLYv5WYKOzS0YzTCMvBN1yl8lF3OSfWZbTuyNSlDUCERj0Qbg1wwS-rkFa8zkSIjpcUbOhlVqybZdUOL5uKnKI0ps_T8Sz0eIlvT9YsuZs=">Journal of the American Medical Association (JAMA) Internal Medicine</a>. ORCA-3 was the second randomized, placebo-controlled Phase 3 clinical trial evaluating cytisinicline for smoking cessation in 792 U.S. adults. The authors concluded that ORCA-3 reaffirms cytisinicline's efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks.
In addition to previously reported <a href="https://www.globenewswire.com/Tracker?data=xGGUKHvpcxeWCIC-Z8NndUDLz7kunUODptVNw36_g3bn81hVavT23ahXHl3YSWWPTZXXuEQI0szEHPNsvgJtsatTNmDU7dwGMmspJobqokCDGVER_nvCWRtOGqqzH87__skWCtumfg4fMfBW1vskjTo62km53Vx0rdLF9aXo9qoZq3un0dbhm20J-BoQWvvK-J3fmIaeO-r0ioXbCjP_qw==">topline results</a> announced in May 2023, the published completed trial results provided further evidence of cytisinicline's highly targeted effect on treating nicotine dependence by binding to specific nicotine receptors. These consistent results, now published from two large, randomized Phase 3 trials, demonstrated that cytisinicline significantly reduced nicotine cravings and increased the likelihood of quitting smoking. In clinical trials, cytisinicline was well tolerated, which is thought to be due to limited other off-target binding effects that can result in side effects known to be associated with currently available treatments.
Similar to the first Phase 3 trial, ORCA-3 participants had an average age of 53 years, smoked a median of 20 cigarettes per day at baseline, and had a median smoking history of 36 years with four prior quit attempts.

News

ACHV

Achieve Life Sciences Says Cytisinicline Phase 3 ORCA-3 Trial Results Showed Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo

Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) reported quarterly losses of $(0.36) per share which missed the analyst consensus estimate of $(0.32) by 12.5 percent. This is a 38.46 percent decrease over losses of $(0.26) per share from the same period last year.

Earnings

Earnings Misses

Achieve Life Sciences Q4 EPS $(0.36) Misses $(0.32) Estimate

<h3>Companies Reporting Before The Bell</h3>
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• Casey's General Stores (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CASY#NASDAQ">CASY</a>) is likely to report quarterly earnings at $2.59 per share on revenue of $3.78 billion. 
• Oil-Dri Corp of America (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ODC#NYSE">ODC</a>) is projected to report earnings for its second quarter. 
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• Bowman Consulting Group (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BWMN#NASDAQ">BWMN</a>) is estimated to report quarterly earnings at $0.27 per share on revenue of $110.71 million. 
• MaxCyte (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MXCT#NASDAQ">MXCT</a>) is estimated to report quarterly loss at $0.13 per share on revenue of $7.67 million. 
• Heritage Insurance Hldgs (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HRTG#NYSE">HRTG</a>) is likely to report quarterly earnings at $0.58 per share on revenue of $208.37 million. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Earnings Scheduled For March 11, 2025

WIIM

Achieve Life Sciences shares are trading higher after the company announced the data safety monitoring committee did not identify any adverse events in the ORCA-OL clinical trial.

Biotech

General

Achieve Life Sciences Announces Data Safety Monitoring Committee Did Not Identify Any Unexpected Treatment-Related Adverse Events In ORCA-OL Clinical Trial

Achieve Life Sciences Reaches Key Milestone In ORCA-OL Cytisinicline Trial With Over 300 Participants Completing Six-Month Treatment; No Safety Concerns Identified, NDA Submission On Track For Q2 2025

Management

Achieve Life Sciences Appoints Mark Oki As CFO, Effective Dec. 5

Achieve Life Sciences Announces Outcome Of End-Of-Phase 2 Meeting With FDA;  Obtained FDA Agreement On Proposed Single Phase 3 Study Design For Cytisinicline Treatment In Vaping Cessation And On Additional Requirements For Submitting Subplemental New Drug Application To Expand Cytisincline For Treatment For Vaping Cessation

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Rodman &amp; Renshaw analyst Brandon Folkes initiated coverage on Adial Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADIL#NASDAQ">ADIL</a>) with a Buy rating and announced a price target of $8. Adial Pharmaceuticals shares closed at $0.9910 on Wednesday. See how other analysts view this stock.</li>
<li>Truist Securities analyst Keith Hughes initiated coverage on Carlisle Companies Incorporated (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CSL#NYSE">CSL</a>) with a Hold rating and announced a price target of $460. Carlisle shares closed at $454.83 on Wednesday. <a href="https://www.benzinga.com/quote/CSL/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Rodman &amp; Renshaw analyst Brandon Folkes initiated coverage on Achieve Life Sciences, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) with a Buy rating and announced a price target of $12. Achieve Life Sciences shares closed at $4.53 on Wednesday. See how other analysts view this stock.</li>
<li>Oppenheimer analyst Ian Zaffino initiated coverage on Turning Point Brands, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TPB#NYSE">TPB</a>) with an Outperform rating and announced a price target of $65. Turning Point Brands shares closed at $55.00 on Wednesday. <a href="https://www.benzinga.com/quote/TPB/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Rodman &amp; Renshaw analyst Brandon Folkes initiated coverage on Rockwell Medical, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RMTI#NASDAQ">RMTI</a>) with a Buy rating and announced a price target of $5. Rockwell Medical shares closed at $2.63 on Wednesday. <a href="https://www.benzinga.com/quote/RMTI/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
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Initiation

Pre-Market Outlook

Analyst Ratings

Trading Ideas

ADIL

RMTI

This Turning Point Brands Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Thursday

Rodman &amp; Renshaw analyst Brandon Folkes initiates coverage on Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) with a Buy rating and announces Price Target of $12.

Price Target

Rodman & Renshaw Initiates Coverage On Achieve Life Sciences with Buy Rating, Announces Price Target of $12

Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) reported quarterly losses of $(0.36) per share which missed the analyst consensus estimate of $(0.26) by 38.46 percent.

Achieve Life Sciences Q3 2024 GAAP EPS $(0.36) Misses $(0.26) Estimate

Achieve Life Sciences Completes Enrollment Of 479 Participants In ORCA-OL Clinical Trial And Reports Outcome From First Data Safety Monitoring Committee Review With No Safety Concerns

Raymond James analyst Gary Nachman initiates coverage on Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) with a Strong Buy rating and announces Price Target of $20.

Raymond James Initiates Coverage On Achieve Life Sciences with Strong Buy Rating, Announces Price Target of $20

Achieve Life Sciences Announces Richard Stewart Reassumes Role Of CEO, Thomas King Appointed Executive Chairman Of The Board; John Bencich To Serve As Advisor During Transition

Oppenheimer analyst Francois Brisebois reiterates Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) with a Outperform and maintains $11 price target.

Reiteration

Oppenheimer Reiterates Outperform on Achieve Life Sciences, Maintains $11 Price Target

Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) reported quarterly losses of $(0.25) per share which missed the analyst consensus estimate of $(0.23) by 8.7 percent.

Achieve Life Sciences Q2 2024 GAAP EPS $(0.25) Misses $(0.23) Estimate

Achieve Life Sciences Announces FDA Granted Breakthrough Therapy Designation For Cytisinicline

Achieve Life Sciences Joins U.S. Russell 3000 And Russell Microcap Indexes

Achieve Life Sciences Initiates ORCA-OL Clinical Trial Evaluating Long-Term Exposure Of Cytisinicline For Nicotine E-Cigarettes Users And Smokers

Events

Achieve Life Sciences To Present Cytisinicline ORCA-V1 Program Data At SGIM Annual Meeting

Press Releases

Achieve Life Sciences Appoints Mark Oki as Chief Financial Officer

Achieve Life Sciences to Host Meetings During the J.P. Morgan Healthcare Conference Week

Health Care

Achieve Life Sciences Announces Critical Milestone Successfully Reached in ORCA-OL Cytisinicline Clinical Trial Required for NDA Submission

Achieve Life Sciences Appoints Dr. Kristen Slaoui and Nancy Phelan to its Board of Directors

Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial

Achieve Life Sciences to Present at the Oppenheimer Healthcare Life Sciences Conference

Achieve Life Sciences to Announce Fourth Quarter and Year-End 2024 Financial Results and Host Conference Call and Webcast on March 11, 2025

Achieve Life Sciences to Present at the Barclays 27th Annual Global Healthcare Conference

Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2024 and Provides Update on the Cytisinicline Development Program

Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine

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