Proactiveinvestors USA & Canada Achieve Life Sciences Inc https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Achieve Life Sciences Inc RSS feed en Mon, 20 May 2019 09:38:53 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Achieve Life Sciences shares rise as data safety committee finds no issues with smoking cessation trial ]]> https://www.proactiveinvestors.com/companies/news/217795/achieve-life-sciences-shares-rise-as-data-safety-committee-finds-no-issues-with-smoking-cessation-trial-217795.html Achieve Life Sciences Inc (NASDAQ:ACHV) shares swirled a bit higher Tuesday as the biotech revealed that the data safety monitoring committee (DSMC) had no issues with its trial of smoking-cessation drug cytisinicline.

The Phase 2b trial called ORCA-1 should continue, it said, while topline efficacy and safety data are expected by the end of the second quarter of 2019.

READ: Achieve Life Sciences shares rocket after a promising smoking-cessation drug trial

Cytisinicline is a plant-based alkaloid and has been an approved, branded product in Central and Eastern Europe for more than two decades to help combat nicotine addiction.

The data safety committee has reviewed the ORCA-1 data twice during the study, and has concluded following each review that there are no safety concerns for subjects or study conduct issues.

The trial is evaluating a 25-day treatment course of 1.5 mg or 3 mg doses of cytisinicline using either a declining titration schedule or three times daily. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups.

The primary efficacy endpoint is the overall reduction in the number of cigarettes smoked during the treatment period.

Shares in Achieve Life Sciences added 1.8% in New York to stand at $3.23

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Tue, 02 Apr 2019 14:57:00 -0400 https://www.proactiveinvestors.com/companies/news/217795/achieve-life-sciences-shares-rise-as-data-safety-committee-finds-no-issues-with-smoking-cessation-trial-217795.html
<![CDATA[News - Achieve Life Sciences shares continue to soar on the back of 4Q earnings results ]]> https://www.proactiveinvestors.com/companies/news/216510/achieve-life-sciences-shares-continue-to-soar-on-the-back-of-4q-earnings-results-216510.html Achieve Life Sciences Inc (NASDAQ:ACHV) shares soared on Friday on the back of year-end and fourth-quarter earnings results that beat analyst estimates.  

Shares of the Washington State-based biotech moved significantly throughout the day on Friday, up 31% at US$3.21 by mid-day. The pharmaceutical group specializes in smoking-cessation techniques. 

The company reported 4Q earnings per share of US$0.55, $0.09 better than analyst estimates of $0.64. 

READ: Achieve Life Sciences shares rocket after promising smoking-cessation drug trial

The company's net loss for the fourth quarter was US$3.6 million. For the year ended December 31, 2018, it was US$12.7 million. 

As of December 31, 2018, the company's cash, cash equivalents, short-term investments and restricted cash were US$14.7 million. Total operating expenses for the fourth quarter and year ended December 31, 2018 were $3.7 million and $12.8 million, respectively. 

The company recently released news that it had completed the enrollment in a Phase 2b trial of its smoking-cessation drug, cytisinicline.  The plant-based compound, also known as cytisine, interacts with the brain’s nicotine receptors to reduce nicotine withdrawal symptoms.

It also recently presented final data from its cytisinicline phase 1/2 multi-dose, pharmacokinetic and pharmacodynamics study at the Society for Research on Nicotine & Tobacco Annual Meeting. 

Contact Katie Lewis at katie@proactiveinvestors.com

-- story updated to reflect share price movement on Friday -- 

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Thu, 14 Mar 2019 16:32:00 -0400 https://www.proactiveinvestors.com/companies/news/216510/achieve-life-sciences-shares-continue-to-soar-on-the-back-of-4q-earnings-results-216510.html
<![CDATA[News - Achieve Life Sciences shares rocket after a promising smoking-cessation drug trial ]]> https://www.proactiveinvestors.com/companies/news/215156/achieve-life-sciences-shares-rocket-after-a-promising-smoking-cessation-drug-trial-215156.html Achieve Life Sciences Inc (NASDAQ:ACHV) shares soared triple digits on Friday on the back of upbeat news from the company's trial of its smoking-cessation drug, cytisinicline.

According to the company, the trial evaluated the effectiveness of the drug cytisinicline on smoking cessation. The plant-based compound, also known as cytisine, interacts with the brain’s nicotine receptors to reduce nicotine withdrawal symptoms.

Shares of the Washington State-based biotech more than doubled to US$3.90.

READ: ImmunoPrecise Antibodies clinches contract from Leidos Biomedical Research

"Given the short 25-day treatment period, the abstinence rates observed are impressive, particularly since subjects were not required to commit to quitting and received minimal behavioral support during the study. These results continue to support our belief that cytisinicline could be a well-tolerated and effective potential treatment option for the millions of people who are battling nicotine addiction," said chief medical officer Dr. Cindy Jacobs.

A total of 26 smokers participated in the study, who smoked an average of 17.2 cigarettes a day. 

The randomized study used 1.5mg and 3mg  doses of cytisinicline over 25 days. 

"All subjects had a significant and immediate reduction in cigarettes smoked within two days of initiating cytisinicline treatment," said the company in a release, adding that by day 26, study participants had an average reduction of 80% in the number of cigarettes smoked during treatment.

Additionally, there was an 82% reduction in expired carbon monoxide and 46% of participants stopped smoking.

According to the company, cytisinicline was well tolerated, with only "transient, mild-to-moderate headache" as the most common side-effect. 

Contact Katie Lewis at katie@proactiveinvestors.com

 

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Fri, 22 Feb 2019 11:29:00 -0500 https://www.proactiveinvestors.com/companies/news/215156/achieve-life-sciences-shares-rocket-after-a-promising-smoking-cessation-drug-trial-215156.html
<![CDATA[News - Achieve Life Sciences to begin Phase 2b trial for its smoking cessation drug ]]> https://www.proactiveinvestors.com/companies/news/208140/achieve-life-sciences-to-begin-phase-2b-trial-for-its-smoking-cessation-drug-208140.html Achieve Life Sciences Inc (NASDAQ:ACHV) shares soared double digits following the announcement that it will begin its Phase 2b trial for Cytisinicline, its smoking cessation drug.

Known as its Ongoing Research of Cytisinicline for Addiction Program, or ORCA, the trial will evaluate the effectiveness of the drug on smoking cessation.

READ: Achieve Life Sciences shares climb following positive results from its smoking cessation study

Shares of the Washington State-based biotech jumped more than 20% to $2.52 in Tuesday Morning trading.

The randomized study will look at 1.5mg and 3mg  doses of cytisinicline over 25 days, as well as three times daily dosing.

The plant-based compound, also known as cytisine, interacts with the brain’s nicotine receptors to reduce nicotine withdrawal symptoms.

The effectiveness of the trial will be determined by the reduction in the number of cigarettes smoked during treatment.

A total of 250 smokers will participate in a study being conducted across eight US centers.

“We intend to utilize our learnings from this trial to finalize the Phase 3 program, expected to begin later next year,”  said CEO Rick Stewart in the company’s press release.

The data results are expected to be made available in mid-2019.

The company also announced that the United States Adopted Names Council adopted "cytisinicline" as the generic name for cytisine.

 

Contact Lenore Fedow at lenore@proactiveinvestors.com

Follow her on Twitter: @LenoreMariee

 

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Tue, 30 Oct 2018 09:49:00 -0400 https://www.proactiveinvestors.com/companies/news/208140/achieve-life-sciences-to-begin-phase-2b-trial-for-its-smoking-cessation-drug-208140.html
<![CDATA[News - Achieve Life Sciences shares climb following positive results from its smoking cessation study ]]> https://www.proactiveinvestors.com/companies/news/205886/achieve-life-sciences-shares-climb-following-positive-results-from-its-smoking-cessation-study-205886.html Achieve Life Sciences Inc (NASDAQ:ACHV) shares soared double digits following the announcement of positive clinical study results of its smoking cessation treatment.

The clinical-stage pharmaceutical company conducted a study looking into the effect of food on cystine’s bioavailability, which refers to the rate at which a drug is absorbed into the system.

Shares of the Washington-based biotech jumped nearly 38% to $3.76 in Thursday pre-market trading.

READ: Achieve Life Sciences shares rise on release of new plan for smoking cessation drug

The plant-based compound interacts with the brain’s nicotine receptors to reduce nicotine withdrawal symptoms.

The study took a look at the bioavailability of a new formulation of 3 mg of cystine in 12 healthy volunteer smokers under fed and fasted conditions.

The results showed that cystine was absorbed with maximum concentration levels observed in the blood within less than two hours, with or without food.

"We believe this new cytisine formulation will allow for an extended shelf-life and will be used in the upcoming Phase 2b clinical trial as well as the Phase 3 clinical program," said CEO Rick Stewart in the company’s press release.

Similar results were found in the study evaluating the previous cystine formulation in 24 healthy non-smoking volunteers.

Tobacco use is the leading cause of preventable death, responsible for nearly six million deaths annually worldwide, according to the World Health Organization’s Report on the Global Tobacco Epidemic.

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Thu, 27 Sep 2018 09:19:00 -0400 https://www.proactiveinvestors.com/companies/news/205886/achieve-life-sciences-shares-climb-following-positive-results-from-its-smoking-cessation-study-205886.html
<![CDATA[News - Achieve Life Sciences shares rise on release of new plan for smoking cessation drug ]]> https://www.proactiveinvestors.com/companies/news/200584/achieve-life-sciences-shares-rise-on-release-of-new-plan-for-smoking-cessation-drug-200584.html \Achieve Life Sciences Inc (NASDAQ:ACHV) shares are soaring in pre-market trading in the wake of the release of its updated development plan for cytisine, its smoking cessation drug.

Prior to the opening bell, Achieve shares jumped 43% to US$5.17.

A recent meeting with the US Food and Drug Administration makes clear the next stages required before Achieve can bring cytisine to market.

“The successful outcome of our discussions with the FDA has provided us with clarity and direction to better inform our Phase 3 clinical development program and our efforts toward expanding cytisine availability,” said Rich Stewart, chief executive of Achieve Life Sciences.

Read: Achieve Life Sciences shares slump on its public stock offering

Taking into account the FDA’s recommendations, Achieve is now set to conduct a Phase 2b optimization trial, which will evaluate 250 smokers in the US and use various cytisine dosing schedules over a 25-day period.

The primary goal of the trial will be to see if the number of cigarettes smoked during treatment is reduced.

Cytisine is a plant-based alkaloid with a high-binding affinity to the nicotinic acetylcholine receptor. It has been used as a smoking cessation treatment across Central and Eastern Europe for more than 15 years.

Achieve will kick off its Phase 2b trial in the fourth quarter of this year and expects to report top-line results for the study by the second quarter of next year.

Once the results from this Phase 2b trial are released, Achieve plans to begin its Phase 3 program for cytisine next year.

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Wed, 11 Jul 2018 08:04:00 -0400 https://www.proactiveinvestors.com/companies/news/200584/achieve-life-sciences-shares-rise-on-release-of-new-plan-for-smoking-cessation-drug-200584.html
<![CDATA[News - Achieve Life Sciences shares soar after results suggest that its anti-smoking aid can be taken with other drugs ]]> https://www.proactiveinvestors.com/companies/news/199594/achieve-life-sciences-shares-soar-after-results-suggest-that-its-anti-smoking-aid-can-be-taken-with-other-drugs-199594.html Achieve Life Sciences Inc (NASDAQ:ACHV) shares surged after data showed that its smoking cessation aid is unlikely to interact negatively with other drugs.

A study into its drug cytisine found no clinically significant interaction with the enzymes responsible for drug metabolism or drug transporters. Results suggest that cytisine can be used alongside other medications without changing the dose of either.

Shares of the Seattle-based company jumped nearly 50% to US$5.57 in Tuesday pre-market trading.

Cytisine is designed to target a nicotine receptor to reduce nicotine cravings and withdrawal symptoms.

“Smokers are as likely as anyone to take medications for a range of conditions. These results suggest that cytisine is unlikely to interfere with their ability to take other medications safely and should help to minimize restrictions on the eligibility of subjects in our forthcoming clinical trials expected to commence later this year," said chief science officer Anthony Clarke in a press statement.

 

Contact Lenore Fedow at lenore@proactiveinvestors.com

Follow her on Twitter: @LenoreMariee

 

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Tue, 26 Jun 2018 08:29:00 -0400 https://www.proactiveinvestors.com/companies/news/199594/achieve-life-sciences-shares-soar-after-results-suggest-that-its-anti-smoking-aid-can-be-taken-with-other-drugs-199594.html
<![CDATA[News - Achieve Life Sciences shares slump on its public stock offering ]]> https://www.proactiveinvestors.com/companies/news/198972/achieve-life-sciences-shares-slump-on-its-public-stock-offering-198972.html Shares in Achieve Life Sciences Inc (NASDAQ:ACHV), a clinical-stage pharmaceutical group specializing in smoking cessation, have plummeted on its announcement of another public stock issue.

In early trade, Achieve Life Sciences slumped 30.4% to US$3.62 on the news.

The offering, which is set to raise US$12m,  is comprised of class A shares priced at US$4 per share; each unit consists of one share plus a five-year warrant to purchase one share of common stock with an exercise price of $4 per share.

The outreach effort also includes class B units, priced at a public offering price of US$1,000 per unit, with each unit comprised of one share of Series A preferred stock, which is convertible into 250 shares of common stock that also carries an exercise price of $4 per share.

A total of 710,500 shares of common stock; 9,158 shares of Series A preferred stock convertible into 2,289,500 shares of common stock; and total warrants to purchase 3,000,000 shares of common stock will be issued as part of the offering.

Ladenburg Thalmann & Co is the book runner on the offering.

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Fri, 15 Jun 2018 11:03:00 -0400 https://www.proactiveinvestors.com/companies/news/198972/achieve-life-sciences-shares-slump-on-its-public-stock-offering-198972.html