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ACHV

Achieve Life Sciences

$1.91

-0.04 (-2.05%)

05:43
09/30/19
09/30
05:43
09/30/19
05:43

Achieve Life Sciences announces completion of MTD study

Achieve Life Sciences announced completion of their maximum tolerated dose, or MTD, study. The results indicate a lack of dose-limiting toxicity as defined by protocol criteria even at the highest 30 mg single, oral dose of cytisinicline evaluated in the study. This study, initiated in March, is required by the FDA as part of a New Drug Application, or NDA, for marketing approval in the United States. It was designed to determine dose-limiting adverse events, or AEs, and to define the maximum tolerated dose for a single, oral dose of cytisinicline. An independent Data Safety Monitoring Committee, or DSMC, composed of the Study Investigator and two independent physicians evaluated all safety outcomes before each dose escalation. Stopping criteria for further dose escalation was defined as the occurrence of severe or serious AEs or any other safety information considered as a concern. The starting dose was 6 mg, which increased in 3 mg increments up to 21 mg. When the MTD was not reached at 21 mg, the study was amended to evaluate doses up to 30 mg. At this dose, the stopping criteria of serious or severe AEs were still not met, but the DSMC recommended stopping the study. The results will be reviewed with the FDA to determine if further escalation beyond 30 mg will be required.

ACHV Achieve Life Sciences
$1.91

-0.04 (-2.05%)

06/11/19
LTCO
06/11/19
NO CHANGE
Target $20
LTCO
Buy
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19
LTCO
06/11/19
NO CHANGE
LTCO
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
Ladenburg analyst Michael Higgins reiterated a Buy rating on Achieve Life Sciences, and raised his price target to $20 from $12, due to positive clinical trial results in the Phase 2 ORCA-1 trial that the company reported this morning. The analyst added that the most important result was "the secondary endpoint of the quit rates at week 4 and at weeks 5-8, since quit rates are the expected primary endpoint in the upcoming pivotal trials." Higgins encouraged investors to build a position in Achieve at current levels.
06/14/19
MAXM
06/14/19
INITIATION
Target $6
MAXM
Buy
Achieve Life Sciences initiated with a Buy at Maxim
Maxim initiated Achieve Life Sciences with a Buy rating and $6 price target.
06/14/19
MAXM
06/14/19
INITIATION
Target $6
MAXM
Buy
Achieve Life Sciences initiated with a Buy at Maxim
Maxim analyst Jason McCarthy initiated Achieve Life Sciences (ACHV) with a Buy rating and a price target of $6, citing the company's development of a "de-risked" smoking cessation aid cytisinicline. The analyst notes that cytisinicline has been in the Eastern European market since the 1970's but has also recently gained "proof of concept" data with a positive phase 2b study of 54% abstinence following 3mg daily intake vs. 16% for placebo. McCarthy adds that Pfizer's (PFE) competing Chantix generated $838M in revenue in FY18 but covered only about 3% of the U.S. smoking population.

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