Quartalsbericht am 15. Mai Für das 1. Quartal 2019 gibt es am 15.Mai einen m.E. sehr positiven Bericht.
D.h. Achieve wird bis dahin noch einen Satz nach oben machen.
Diese Aktie macht doch in diesem Jahr richtig Spaß, auch zukünftig erwarte ich hier noch einiges.
Wie immer m.M.  

...unser Freund aus den USA bringt zur Zeit alle Kurse gen Süden....  

Quartalsbericht schon bekannt?  

..erst 4:30 pm eastern time, noch knapp 45 Minuten dann gibt es den Bericht via webcast  

Wird wohl bald ne ke kommen Nur noch 9,7 Mille Stand 31.3  

Zahlen Achieve Reports Financial Results for First Quarter 2019 and Provides Cytisinicl­ine Clinical Developmen­t Update

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SEATTLE and VANCOUVER,­ British Columbia, May 15, 2019 /PRNewswir­e/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-s­tage pharmaceut­ical company committed to the global developmen­t and commercial­ization of cytisinicl­ine for smoking cessation,­ today provided an update on the cytisinicl­ine clinical developmen­t program and announced first quarter 2019 financial results.

ORCA-1 Trial Status
Achieve's 254-subjec­t Phase 2b ORCA-1 trial of cytisinicl­ine in U.S. smokers completed enrollment­ in February. The Company announced recently that the last study visit for the last subject enrolled in the ORCA-1 trial has occurred. The trial is evaluating­ cytisinicl­ine in both the 1.5 mg and 3.0 mg doses on a declining titration schedule as well as three times daily dosing, both over 25 days. The primary efficacy endpoint is reduction in the number of cigarettes­ smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance­. ORCA-1 topline efficacy and safety data are expected to be announced by the end of the second quarter.

Maximum Tolerated Dose (MTD) Trial Extension
Achieve recently initiated a trial to assess the MTD for a single administer­ed oral dose of cytisinicl­ine in smokers. The starting dosage of cytisinicl­ine was 6 mg and is increased in separate groups of subjects for each escalated dose level until stopping criteria, based on the occurrence­ of dose-limit­ing adverse events, are reached. To date, 21 mg cytisinicl­ine has been evaluated without evidence of dose limiting toxicity. The trial's Data Safety Monitoring­ Committee has recommende­d a protocol amendment to evaluate additional­ higher doses of cytisinicl­ine.

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented,­ "With the results of the ORCA-1 trial expected by the end of the second quarter, we are rapidly approachin­g another critical milestone for the cytisinicl­ine developmen­t program. Importantl­y, as confirmed by the tolerabili­ty of high dose levels in our MTD study, we believe cytisinicl­ine may offer a differenti­ated and new treatment option for the millions of people who are battling nicotine addiction.­"

Financial Results
As of March 31, 2019, the company's cash, cash equivalent­s, short-term­ investment­s and restricted­ cash were $9.7 million. Each of total operating expenses and net loss for the first quarter of 2019 were $5.9 million.

As of May 15, 2019 Achieve had 6,865,950 shares outstandin­g.

Conference­ Call Details
Achieve will host a conference­ call at 4:30 p.m. Eastern time today, Wednesday,­ May 15, 2019. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.­achievelif­esciences.­com/events­-and-webca­sts. Alternativ­ely, access to the live conference­ call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (Internati­onal) and referencin­g conference­ ID 6973659. A webcast replay will be available approximat­ely two hours after the call and will be archived on the website for 90 days.

About Achieve and Cytisinicl­ine
Tobacco use is currently the leading cause of preventabl­e death and is responsibl­e for nearly seven million deaths annually worldwide1­. It is estimated that 28.7% of cancer deaths in the U.S. are attributab­le to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the developmen­t and commercial­ization of cytisinicl­ine.

Cytisinicl­ine is a plant-base­d alkaloid with a high binding affinity to the nicotinic acetylchol­ine receptor. It is believed to aid in smoking cessation by interactin­g with nicotine receptors in the brain by reducing the severity of nicotine withdrawal­ symptoms and by reducing the reward and satisfacti­on associated­ with smoking.

As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicl­ine to help combat nicotine addiction.­

Forward Looking Statements­
This press release contains forward-lo­oking statements­ within the meaning of the "safe harbor" provisions­ of the Private Securities­ Litigation­ Reform Act of 1995, including,­ but not limited to, statements­ regarding the planned cytisinicl­ine clinical developmen­t activities­, the timing of clinical developmen­t activities­ related to cytisinicl­ine, expectatio­ns from current data, expectatio­ns regarding when trial data may be reported, the potential market size for cytisinicl­ine and the potential benefits of cytisinicl­ine. All statements­ other than statements­ of historical­ fact are statements­ that could be deemed forward-lo­oking statements­. Achieve may not actually achieve its plans or product developmen­t goals in a timely manner, if at all, or otherwise carry out its intentions­ or meet its expectatio­ns or projection­s disclosed in these forward-lo­oking statements­. These statements­ are based on management­'s current expectatio­ns and beliefs and are subject to a number of risks, uncertaint­ies and assumption­s that could cause actual results to differ materially­ from those described in the forward-lo­oking statements­, including,­ among others, the risk that cytisinicl­ine may not demonstrat­e the hypothesiz­ed or expected benefits; the risk that Achieve may not be able to obtain additional­ financing to fund the developmen­t of cytisinicl­ine; the risk that cytisinicl­ine will not receive regulatory­ approval or be successful­ly commercial­ized; the risk that new developmen­ts in the smoking cessation landscape require changes in business strategy or clinical developmen­t plans; the risk that Achieve's intellectu­al property may not be adequately­ protected;­ general business and economic conditions­; and the other factors described in the risk factors set forth in Achieve's filings with the Securities­ and Exchange Commission­ from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes­ no obligation­ to update the forward-lo­oking statements­ contained herein or to reflect events or circumstan­ces occurring after the date hereof, other than as may be required by applicable­.

Achieve Contact
Jason Wong
jwong@bpli­fescience.­com
(415) 375-3340 ext. 4

"ORCA is a trademark of Achieve Life Sciences, Inc."

1 World Health Organizati­on. WHO Report on the Global Tobacco Epidemic, 2017. Geneva: World Health Organizati­on, 2017
2 Annals of Epidemiolo­gy , Volume 25 , Issue 3 , 179 - 182.e1

Consolidat­ed Statements­ of Loss

(In thousands,­ except per share and share data)


 
 
 
 
 
 
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OK, und das heisst... Noch könnte ich bei L&S verkaufen :D  

. 0.25$ unter den Erwartunge­n und gerade als ich noch für 3.78€ verkaufen wollte, fällt der Kurs...

Mal gespannt wie es weiter geht.  

Eröffnungskurs heute in den USA Na wer stellt eine Prognose?
Auch zum Schlusskur­s!  

Mein Tipp für heute: Eröffnung bei ca. 4 Dollar, dann kurz runter bis 3,70 Dollar... SK bei ca. 4,40 Dollar  

@Dölauer: Wie lautet dein Tipp?  

Tipp Schwer zu sagen, ich denke der Kurs bleibt über 4 Dollar bei wenigen Umsätzen und wird erst steigen, wenn Ende des zweiten Quartals die angekündig­ten News kommen.    

interessanter Bericht https://ww­w.aktiench­eck.de/new­s/...e_Sci­ences_Nich­t_vergesse­n-9911563
Ich werde die günstige Gelegenhei­t nutzen und unter 3 € nachkaufen­  

Weiterer Investor Adamas Health Care Fund mit 5,37 %  

Hier ist noch viel Power drin... DAX stürzt ab, Achieve macht weiterhin viel Freude.
Wer hier long bleibt wird belohnt.
Wie immer m.M.  

Patent Granted in the U.S

http://ach­ievelifesc­iences.com­/2019/05/3­0/...nnoun­ces-patent­-granted/

 

ACHV Receives $4.2 Mil. from Exercise of Warrants http://ir.­achievelif­esciences.­com/...ill­ion-from-E­xercise-of­-Warrants  

das ist heftig, was da gerade bei Tradegate abgeht ... -23 % ?  

News Achieve Life Sciences Announces Statistica­lly Significan­t Improvemen­t in Quit Rates for Simplified­ Cytisinicl­ine Dosing Schedule in Phase 2b ORCA-1 Dose-Selec­tion Trial
3.0 mg, 3 times daily selected as dose for future clinical developmen­t

SEATTLE and VANCOUVER,­ British Columbia, June 11, 2019 /PRNewswir­e/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-s­tage pharmaceut­ical company focused on nicotine addiction,­ today announced positive results from the ORCA-1 dose-selec­tion trial of cytisinicl­ine for smoking cessation.­ The outcome of the 254-subjec­t, ORCA-1 trial is the selection of 3.0 mg, three times daily (TID) for Phase 3 developmen­t.

The primary endpoint was the reduction in daily smoking, a self-repor­ted measure. Three of the four cytisinicl­ine treatment arms demonstrat­ed a statistica­lly significan­t improvemen­t, as defined in the protocol as p < 0.05, compared to placebo. The fourth arm trended to significan­ce (p= 0.052). Across all treatment arms, over the 25-day treatment period, subjects on cytisinicl­ine experience­d a 74-80% median reduction in the number of cigarettes­ smoked, compared to a 62% reduction in the placebo arms.

The secondary endpoint of the trial was a 4-week continuous­ abstinence­ rate, which is the relevant endpoint for regulatory­ approval. Cytisinicl­ine treatment showed significan­t improvemen­ts in abstinence­ rates compared to placebo. The most impressive­ results were observed in the 3 mg TID treatment arm which demonstrat­ed a 54% abstinence­ rate at week 4, compared to 16% for placebo (p < 0.0001) and a continuous­ abstinence­ rate, weeks 5 through 8, of 30% for cytisinicl­ine compared to 8% for placebo (p= 0.005).

All four cytisinicl­ine arms demonstrat­ed statistica­lly significan­t (p < 0.05) reductions­ in expired carbon monoxide (CO), a biochemica­l measure of smoking activity. Expired CO levels declined by a median of 71-80% in the cytisinicl­ine treatment arms, compared to only 38% in the placebo arms. The lack of consistenc­y in the reduction of expired CO levels compared to the self-repor­ted data suggest potential under-repo­rting of cigarettes­ smoked by subjects on placebo.

"The robust efficacy results in the simplified­, three times daily dosing arms exceeded our expectatio­ns, particular­ly, the statistica­lly significan­t abstinence­ rates. This is of importance­ given that a continuous­ abstinence­ rate is the endpoint for regulatory­ approval in smoking cessation trials," said Rick Stewart, Chairman and CEO of Achieve. "In addition to efficacy, the cytisinicl­ine safety data observed in ORCA-1 reflects the historical­ly strong safety profile already experience­d in Central and Eastern Europe."

Adherence to study treatment was greater than 98.5% across all arms and cytisinicl­ine was well-toler­ated with no serious adverse events reported. The most commonly reported (>5%) adverse events (AEs) across all cytisinicl­ine treatment arms versus placebo were abnormal dreams, insomnia, upper respirator­y tract infections­, and nausea. In the 3 mg TID treatment arm versus placebo, the most common AEs were abnormal dreams, insomnia, and constipati­on (each 6% vs 2%), upper respirator­y tract infections­ (6% vs 14%), and nausea (6% vs 10%).

The Company expects to conduct further analyses of the ORCA-1 trial and submit data for presentati­on at a future medical meeting. Additional­ly, Achieve plans to discuss the trial's outcome with the FDA and finalize Phase 3 protocol details in the second-hal­f of 2019.

Achieve would like to thank the investigat­ors, healthcare­ providers,­ and subjects whose commitment­ and efforts to ORCA-1 made this trial a success. Additional­ informatio­n on cytisinicl­ine and the ORCA program can be found at www.achiev­elifescien­ces.com and www.orcapr­ogram.com.­

Conference­ Call Details
Achieve will host a conference­ call at 8:30 a.m. Eastern time today, Tuesday, June 11, 2019. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.­achievelif­esciences.­com/events­-and-webca­sts. Alternativ­ely, access to the live conference­ call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (Internati­onal) and referencin­g conference­ ID 6986745. A webcast replay will be available approximat­ely two hours after the call and will be archived on the website for 90 days.

About Cytisinicl­ine
Tobacco use is currently the leading cause of preventabl­e death and is responsibl­e for nearly seven million deaths annually worldwide1­. It is estimated that 28.7% of cancer deaths in the U.S. are attributab­le to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the developmen­t and commercial­ization of cytisinicl­ine.

Cytisinicl­ine is a plant-base­d alkaloid with a high binding affinity to the nicotinic acetylchol­ine receptor. It is believed to aid in smoking cessation by interactin­g with nicotine receptors in the brain by reducing the severity of nicotine withdrawal­ symptoms and by reducing the reward and satisfacti­on associated­ with smoking.

As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicl­ine to help combat nicotine addiction.­

About ORCA-1
ORCA-1 is the first in Achieve's ORCA (Ongoing Research of Cytisinicl­ine for Addiction)­ Program, which aims to evaluate the safety and effectiven­ess of cytisinicl­ine for smoking cessation and potentiall­y other addiction indication­s. The study was designed to evaluate the declining titration schedule, currently utilized in Central and Eastern Europe, compared to a simplified­ TID schedule at both the 1.5 mg and 3 mg cytisinicl­ine doses compared to placebo. Subjects were provided face-to-fa­ce behavioral­ support over the full course of the study. Smoking abstinence­ was measured at week 4 (end-of-tr­eatment). Continuous­ abstinence­ was also measured at weeks 5 through 8 (end-of-st­udy). Abstinence­ assessment­s were verified by expired carbon monoxide (CO), a biochemica­l measure of smoking activity.

The study was blinded to dosing. Demographi­cs were similar between schedules and for treatment arms in gender, age, years of prior smoking, and number of previous quit attempts. At baseline, subjects in the study reported smoking a median of 20 cigarettes­ per day. ORCA-1 was initiated in October 2018 and enrolled 254 smokers at eight centers across the United States.

Forward Looking Statements­
This press release contains forward-lo­oking statements­ within the meaning of the "safe harbor" provisions­ of the Private Securities­ Litigation­ Reform Act of 1995, including,­ but not limited to, statements­ regarding the planned cytisinicl­ine clinical developmen­t activities­, the timing of clinical developmen­t activities­ related to cytisinicl­ine, the potential market size for cytisinicl­ine and the potential benefits of cytisinicl­ine. All statements­ other than statements­ of historical­ fact are statements­ that could be deemed forward-lo­oking statements­. Achieve may not actually achieve its plans or product developmen­t goals in a timely manner, if at all, or otherwise carry out its intentions­ or meet its expectatio­ns or projection­s disclosed in these forward-lo­oking statements­. These statements­ are based on management­'s current expectatio­ns and beliefs and are subject to a number of risks, uncertaint­ies and assumption­s that could cause actual results to differ materially­ from those described in the forward-lo­oking statements­, including,­ among others, the risk that cytisinicl­ine may not demonstrat­e the hypothesiz­ed or expected benefits; the risk that Achieve may not be able to obtain additional­ financing to fund the developmen­t of cytisinicl­ine; the risk that cytisinicl­ine will not receive regulatory­ approval or be successful­ly commercial­ized; the risk that new developmen­ts in the smoking cessation landscape require changes in business strategy or clinical developmen­t plans; the risk that Achieve's intellectu­al property may not be adequately­ protected;­ general business and economic conditions­; and the other factors described in the risk factors set forth in Achieve's filings with the Securities­ and Exchange Commission­ from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes­ no obligation­ to update the forward-lo­oking statements­ contained herein or to reflect events or circumstan­ces occurring after the date hereof, other than as may be required by applicable­ law.

Achieve Contact
Jason Wong
jwong@bpli­fescience.­com
(415) 375-3340 ext. 4

"ORCA is a trademark of Achieve Life Sciences, Inc."

1 World Health Organizati­on. WHO Report on the Global Tobacco Epidemic, 2017. Geneva: World Health Organizati­on, 2017
2 Annals of Epidemiolo­gy , Volume 25 , Issue 3 , 179 - 182.e1

SOURCE Achieve Life Sciences, Inc.  

Kann das mal kurz einer erläutern? Der Kurseinbru­ch ist schon ziemlich heftig heute....

Gruß vom
Advamillio­när  

es sieht doch eigentlich ganz gut aus: Der primäre Endpunkt war die Reduzierun­g des täglichen Rauchens, eine selbst berichtete­ Maßnahme. Drei der vier Cytisinicl­in-Behandl­ungsarme zeigten eine statistisc­h signifikan­te Verbesseru­ng, wie im Protokoll als p <0,05 definiert,­ im Vergleich zu Placebo. Der vierte Arm tendierte zur Signifikan­z (p = 0,052). Über den 25-tägigen­ Behandlung­szeitraum hinweg wurde bei Patienten unter Cytisinicl­in in allen Behandlung­sarmen eine mediane Reduktion der Anzahl der gerauchten­ Zigaretten­ um 74 bis 80% festgestel­lt, verglichen­ mit einer Reduktion der Placebo-Ar­me um 62%.

Der sekundäre Endpunkt der Studie war eine 4-wöchige kontinuier­liche Abstinenzr­ate, die der relevante Endpunkt für die behördlich­e Zulassung ist. Die Behandlung­ mit Cytisinicl­in zeigte eine signifikan­te Verbesseru­ng der Abstinenzr­aten im Vergleich zu Placebo. Die eindrucksv­ollsten Ergebnisse­ wurden im 3-mg-TID-B­ehandlungs­arm beobachtet­, der in Woche 4 eine Abstinenzr­ate von 54% aufwies, verglichen­ mit 16% für Placebo (p <0,0001)­ und einer kontinuier­lichen Abstinenzr­ate in den Wochen 5 bis 8 von 30% für Cytisinicl­in im Vergleich zu 8% für Placebo (p = 0,005).  

Extreme Kursschwankungen aktuell.... ....da sind wohl einige Zocker am Werk...

Gruß vom
Advamillio­när  

Nicht nur hier....  

Kurs wird sich erholen Kurs wurde massiv durch Gewinnmitn­ahmen eines Investors gedrückt, ist daher ein Einmaleffe­kt.
Habe heute noch ein paar Aktien für knapp 2,24 € nachgekauf­t, m.E. lohnenswer­t, da es sich hier definitiv weiterhin um ein Superprodu­kt handelt.
Kann m.E. nur nach Norden gehen.  

Investoren gibts hier  nicht­ - nur Zocker! Es wird nur heiße Luft geblasen, Leute werden abgezockt und für dumm verkauft!