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

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>.
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<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>
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News

Initiation

Pre-Market Outlook

Analyst Ratings

Trading Ideas

ACHV

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.

Earnings

Earnings Misses

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

Biotech

General

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

Management

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

Oppenheimer analyst Francois Brisebois maintains Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) with a Outperform and lowers the price target from $18 to $11.

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

Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) reported quarterly losses of $(0.26) per share which missed the analyst consensus estimate of $(0.24) by 8.33 percent. This is a 48 percent increase over losses of $(0.50) per share from the same period last year.

Achieve Life Sciences Q1 2024 GAAP EPS $(0.26) Misses $(0.24) Estimate

Phase 2 ORCA-V1 trial showed treatment with cytisinicline more than doubled odds of quitting e-cigarettes compared with placebo&nbsp;&nbsp; &nbsp;
Cytisinicline treatment well tolerated with no serious adverse events reported and excellent compliance to study treatment
Achieve expects to conduct an End-of-Phase 2 Meeting with the FDA later this year to discuss Phase 3 trial plans
SEATTLE and VANCOUVER, British Columbia, May 06, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced publication of the ORCA-V1 trial results in the <a href="https://www.globenewswire.com/Tracker?data=Gq9yz5diOoiKyernnFUh8VdrklLP-O9c4NqIca-DOgHYcWnpvODIO-3APPnQ_xTaM5yU8KBjLbcKA3IXVMST7C63rj3NmzhCYUpkWgDmd9sfV1Ax-u8Fv53BT8XGaCLQhpuuIZvEs4hVObGQeZtEY0ZE25s5MuJakx_FUK9N0oLQoGWUfqSuywCk7r16TtoxIz5zPE438Y8fOBByvI_eTwPmE5MScl_SnHOvbLfWxqU=">Journal of the American Medical Association (JAMA) Internal Medicine</a>. ORCA-V1 evaluated the efficacy and safety of 3 mg cytisinicline dosed three times daily for 12 weeks compared to placebo in 160 non-smoking adults who used e-cigarettes or nicotine vapes and wanted to quit e-cigarettes. All participants received behavioral support for vaping cessation.
As reported today, the ORCA-V1 trial demonstrated that biochemically confirmed continuous vaping abstinence during the last 4 weeks of treatment, the primary outcome measure, was significantly higher for cytisinicline treatment compared to placebo. For cytisinicline treatment compared to placebo, 31.8% versus 15.1% of participants were abstinent during weeks 9 to 12, and participants receiving cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping (odds ratio (OR) 2.64 [95% CI, 1.06-7.10]; P=.04)
A consistent trend in favor of cytisinicline was found across the secondary endpoints, evaluating abstinence during and beyond end of treatment. During the 12-week study treatment, the past seven-day prevalence of vaping abstinence at each week was consistently higher in the cytisinicline group than the placebo group. Similarly, the mean biochemical cotinine levels were consistently lower in the cytisinicline group than the placebo group at each weekly visit during study treatment. Including a four-week follow-up after treatment ended, continuous abstinence from weeks 9 to 16 remained higher in the cytisinicline group than the placebo group at 23.4% versus 13.2%, respectively (OR, 2.0; [95% CI, 0.82-5.32]).
"Many people who use e-cigarettes want to quit but find it difficult due to nicotine dependence. They need help to stop vaping, yet no FDA-approved medication is currently available to help them do so," said Dr. Nancy Rigotti, Director, Tobacco Research and Treatment Center&nbsp;Massachusetts General Hospital, Professor of Medicine at Harvard Medical School, and Principal Investigator of ORCA-V1. "Cytisinicline has been shown in clinical trials to be effective and safe to help adults stop smoking cigarettes. The results of this study indicate that it might also help people to quit vaping."
Study drug compliance was high; 72.7% and 66.0% of participants treated with cytisinicline and placebo, respectively, took &gt;90% of study drug doses. Cytisinicline was well tolerated and no serious adverse events were reported. Similar rates of adverse events were observed between treatment arms (50.9% in the cytisinicline arm versus 54.7% in the placebo arm). The most frequent (&gt;5%) treatment-emergent adverse events for cytisinicline subjects were sleep disturbances, anxiety, headache, fatigue, and upper respiratory tract infection and for placebo subjects were nausea, COVID-19, headache, anxiety and upper respiratory tract infection. Higher rates of headache and nausea were reported by participants treated with placebo.
"As we've seen now in multiple clinical trials, the safety and tolerability profile of cytisinicline is very compelling and we believe it will be a key driver of compliance when approved for use," commented Cindy Jacobs, MD, PhD, President and Chief Medical Officer at Achieve. "Many people who attempt to quit nicotine struggle with withdrawal symptoms and cravings, making it difficult to maintain abstinence. Current treatments can have high rates of headaches and nausea, and we are simply not seeing that with cytisinicline, giving us confidence that cytisinicline's profile will help more people, who want to quit, succeed in doing so."
The prevalence of e-cigarette use by adults in the United States continues to rise. It is estimated that 4.5% among all adults in the United States and 11% among adults aged 18-24 used e-cigarettes in 2021. While adults who switch from smoking combustible cigarettes to using nicotine e-cigarettes reduce their tobacco-related health risks, e-cigarettes products are not harmless and sustain nicotine dependence. In surveys, more than half of adults who vape nicotine plan to quit. Cytisinicline, if approved, could be the first prescription drug to help people who are ready to address their addiction to e-cigarettes. Achieve plans to conduct an End-of-Phase 2 Meeting with the FDA later this year to discuss future clinical trial requirements to pursue an indication for vaping cessation.
The research and clinical study discussed in this press release was supported in part by the National Institute on Drug Abuse of the National Institutes of Health (NIH) under Award Number 4R44DA054784-02. The content of this press release is the sole responsibility of the authors and does not necessarily represent the official views of the NIH.
About ORCA-V1 The Phase 2 ORCA-V1 trial evaluated 160 adults who used e-cigarettes on a daily basis at five clinical trial locations in the United States. ORCA-V1 participants were randomized to receive 3mg cytisinicline three times daily or placebo for 12 weeks in combination with standard cessation behavioral support. The dose and administration of cytisinicline in the ORCA-V1 study is identical to that used in the Phase 3 registrational trials for smoking cessation. ORCA-V1 was supported in part by the National Institute on Drug Abuse (NIDA) of the NIH through grant funding which was awarded in two phases totaling $2.8 million.

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

Offerings

Achieve Life Sciences Files Prospectus Related To Offer & Sale From Time To Time Of Up To 13.1M Shares Of Common Stock, By Selling Stockholders

JonesTrading analyst Justin Walsh 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 $20.

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

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 $18 price target.

Oppenheimer Reiterates Outperform on Achieve Life Sciences, Maintains $18 Price Target

Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) reported its Q4 earnings results on Thursday, March 28, 2024 at 04:01 PM.
Here's what investors need to know about the announcement.
<h3>Earnings</h3>
Achieve Life Sciences beat estimated earnings by 16.0%, reporting an EPS of $-0.26 versus an estimate of $-0.31.
Revenue was down $0 from the same period last year.
<h3>Past Earnings Performance</h3>
Last quarter the company beat on EPS by $0.04 which was followed by a 2.0% drop in the share price the next day.

To track all earnings releases for Achieve Life Sciences <a href="https://www.benzinga.com/quote/ACHV/earnings">visit their earnings calendar here.</a> 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Recap: Achieve Life Sciences Q4 Earnings

Achieve Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHV#NASDAQ">ACHV</a>) reported quarterly losses of $(0.26) per share which beat the analyst consensus estimate of $(0.31) by 16.13 percent. This is a 68.67 percent increase over losses of $(0.83) per share from the same period last year.

Achieve Life Sciences Q4 EPS $(0.26) Beats $(0.31) Estimate

JonesTrading analyst Justin Walsh has reiterated their bullish stance on ACHV stock, giving a Buy rating today. Justin Walsh has given his Buy rati...

Optimistic Outlook for Achieve Life Sciences as ORCA-OL Trial Advances and NDA Submission Approaches

In a report released today, Thomas Flaten from Lake Street maintained a Buy rating on Achieve Life Sciences (ACHV – Research Report), with a price ...

Lake Street Keeps Their Buy Rating on Achieve Life Sciences (ACHV)

Achieve Life Sciences Q3 2024 Earnings Preview

Here are the major earnings after the close today

"This is an incredibly exciting time at Achieve, as we remain steadfastly focused on advancing cytisinicline to address the urgent need for effecti...

Achieve Life Sciences reports Q3 EPS (36c), consensus (26c)

In a report released today, Francois Brisebois from Oppenheimer maintained a Buy rating on Achieve Life Sciences (ACHV – Research Report), with a p...

Oppenheimer Keeps Their Buy Rating on Achieve Life Sciences (ACHV)

Achieve Life Sciences, Inc. (ACHV) Q3 2024 Earnings Call Transcript

Achieve Life Sciences (ACHV – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst yesterday. Analyst Jason McCa...

Achieve Life Sciences: Promising Future with Strategic Leadership and Strong Financial Position Justifies Buy Rating

JonesTrading analyst Justin Walsh has reiterated their bullish stance on ACHV stock, giving a Buy rating on November 8. Justin Walsh's rating is ba...

Achieve Life Sciences Poised for U.S. Launch of Cytisinicline with Strong Financial and Strategic Foundations

Rodman & Renshaw initiated coverage of Achieve Life Sciences (ACHV) with a Buy rating and $12 price target Achieve is dedicated to addressing the g...

Achieve Life Sciences initiated with a Buy at Rodman & Renshaw

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Health Care

Press Releases

Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence

Achieve Life Sciences Reports Financial Results for Second Quarter 2024 and Provides Corporate Update

Achieve Life Sciences Announces Changes in Executive Leadership and Board of Directors

Achieve Life Sciences Strengthens Leadership with Appointment of Dr. Mark Rubinstein, Nicotine Dependence Expert, as New Head of Medical Affairs

Achieve Life Sciences Announces Completion of Enrollment in ORCA-OL Clinical Trial & Successful Outcome of the First Data Safety Monitoring Committee Meeting

Achieve Life Sciences Promotes Jaime Xinos to Chief Commercial Officer to Advance Commercial Readiness of Cytisinicline

Achieve Life Sciences President and CMO, Dr. Cindy Jacobs, Speaks at FDA and NIH Smoking Cessation Public Meeting

Achieve Life Sciences to Announce Third Quarter Financial Results and Host Conference Call and Webcast on November 7, 2024

Achieve Life Sciences Reports Financial Results for Third Quarter 2024 and Provides Corporate Update

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Achieve Life Sciences

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

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