Breaking News

Monday
Show Full Stories

X

To view all stories in expanded form, please subscribe.
Send Info
Syndicate
Achieve Life Sciences raises $6M in a registered direct offering » 08:42
06/29/20
06/29
08:42
06/29/20
08:42
ACHV

Achieve Life Sciences

$0.41 /

-0.0127 (-3.04%)

Achieve Life Sciences has…

Achieve Life Sciences has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of 14,634,146 shares of common stock at a price of $0.41 per share in a registered direct offering, resulting in total gross proceeds of approximately $6 million. Lake Street Capital Markets LLC is acting as exclusive placement agent for the registered direct offering.

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$0.41 /

-0.0127 (-3.04%)

ACHV Achieve Life Sciences
$0.41 /

-0.0127 (-3.04%)

02/25/20 H.C. Wainwright
Achieve Life Sciences initiated with a Buy at H.C. Wainwright
ACHV Achieve Life Sciences
$0.41 /

-0.0127 (-3.04%)

Over a week ago
Syndicate
Achieve Life Sciences files to sell 10.33M shares of common stock for holders  16:23
06/05/20
06/05
16:23
06/05/20
16:23
ACHV

Achieve Life Sciences

$0.47 /

+0.022 (+4.91%)

 
ShowHide Related Items >><<
ACHV Achieve Life Sciences
$0.47 /

+0.022 (+4.91%)

ACHV Achieve Life Sciences
$0.47 /

+0.022 (+4.91%)

02/25/20 H.C. Wainwright
Achieve Life Sciences initiated with a Buy at H.C. Wainwright
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
ACHV Achieve Life Sciences
$0.47 /

+0.022 (+4.91%)

Over a quarter ago
Earnings
Achieve Life Sciences reports Q4 EPS (30c), consensus (32c) » 08:05
03/13/20
03/13
08:05
03/13/20
08:05
ACHV

Achieve Life Sciences

$0.35 /

-0.0667 (-16.00%)

In the fourth quarter of…

In the fourth quarter of 2019, Achieve received feedback on the Phase 3 clinical trial protocols and the cytisinicline clinical development program. Specifically, the FDA agreed with the overall Phase 3 study designs that anticipate utilizing the simplified cytisinicline dosing schedule of 3.0 mg administered three times daily and the duration of 6 and 12 weeks of treatment. Additionally, the FDA agreed that no further escalation in cytisinicline dosing beyond the 30.0 mg dose was necessary for defining a maximum tolerated dose, which is required for the New Drug Application.

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$0.35 /

-0.0667 (-16.00%)

02/25/20 H.C. Wainwright
Achieve Life Sciences initiated with a Buy at H.C. Wainwright
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
Initiation
Achieve Life Sciences initiated with a Buy at H.C. Wainwright » 07:05
02/25/20
02/25
07:05
02/25/20
07:05
ACHV

Achieve Life Sciences

$0.50 /

-0.0105 (-2.07%)

H.C. Wainwright analyst…

H.C. Wainwright analyst Vernon Bernardino initiated coverage of Achieve Life Sciences with a Buy rating and $2 price target. The company is in Phase 3 clinical-stage development with cytisinicline for smoking cessation and nicotine addiction. The analyst believes cytisinicline is a "differentiated and better" smoking cessation option, which makes him bullish on shares of Achieve. Cytisinicline targets a significant market opportunity, presents a well differentiated product profile, and is supported by a solid foundation of clinical evidence, says Bernardino.

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$0.50 /

-0.0105 (-2.07%)

06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
Hot Stocks
Achieve Life Sciences, Oracle announce study results with cloud infrastructure » 06:43
01/13/20
01/13
06:43
01/13/20
06:43
ACHV

Achieve Life Sciences

$0.61 /

+0.0541 (+9.69%)

, ORCL

Oracle

$54.45 /

+0.08 (+0.15%)

Achieve Life Sciences…

Achieve Life Sciences (ACHV), University of Bristol and Oracle (ORCL) announced the outcome of a study using Oracle's cloud infrastructure to potentially improve the speed of drug discovery and development of new treatments. The study was led by scientists from the University of Bristol and recently published in the Journal of the American Chemical Society. It aimed to evaluate how receptors in the brain respond to nicotine. Researchers utilized new computational simulation methods to conduct 450 individual assessments of the biochemistry associated with the binding of nicotine to a subtype of nicotinic acetylcholine receptors, a key mechanism believed to be responsible for the highly-addictive nature of nicotine. Computations were achieved in five days using Oracle's cloud infrastructure. The campany said the "speed of results represents a breakthrough in computational chemistry and is transformational from a research perspective." Achieve Life Sciences has partnered with the University of Bristol to formulate molecules and potential treatments to combat addiction and neurological disorders based on their lead smoking cessation compound in development, cytisinicline. Building on this research and previously conducted studies, cloud-based computer simulations can now be utilized to evaluate the effectiveness of potential new treatments and help to accelerate the pace of discovery.

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$0.61 /

+0.0541 (+9.69%)

06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
ORCL Oracle
$54.45 /

+0.08 (+0.15%)

12/13/19 Raymond James
Oracle price target lowered to $57 from $61 at Raymond James
12/13/19 Barclays
Oracle shares to come under near-term pressure, says Barclays
12/13/19 Wedbush
Oracle price target raised to $56 from $55 at Wedbush
11/13/19 Piper Sandler
Oracle assumed with a Neutral at Piper Jaffray
Hot Stocks
Achieve Life Sciences announces completion of meeting with FDA » 05:46
12/09/19
12/09
05:46
12/09/19
05:46
ACHV

Achieve Life Sciences

$0.91 /

-0.0503 (-5.21%)

Achieve Life Sciences…

Achieve Life Sciences announced an update on the cytisinicline clinical development program. Following discussions with the FDA, Achieve has received feedback on the final Phase 3 clinical trial protocols and the cytisinicline clinical development program. Specifically, the FDA has agreed with the overall Phase 3 study designs that will utilize the simplified cytisinicline dosing schedule of 3.0 mg administered three times daily and the duration of 6 and 12 weeks of treatment. The FDA also agreed that the use of the newly-developed, single 3.0 mg cytisinicline tablet in the Phase 3 program was acceptable. Minimal changes to the Phase 3 protocol were discussed and agreed upon by both Achieve and the FDA. No changes were required for the primary and secondary analyses. Achieve agreed to complete a second chronic toxicology study supporting the 12 weeks of treatment prior to initiating the Phase 3 program. The chronic toxicology study report is expected to be available and submitted to the FDA in the first quarter of 2020. The FDA agreed that no further escalation in cytisinicline dosing beyond the 30.0 mg dose was necessary for defining a maximum tolerated dose, which is required for the New Drug Application.

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$0.91 /

-0.0503 (-5.21%)

06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
Earnings
Achieve Life Sciences reports Q3 EPS (45c), consensus (30c) » 06:40
11/06/19
11/06
06:40
11/06/19
06:40
ACHV

Achieve Life Sciences

$1.22 /

-0.08 (-6.15%)

As of September 30, the…

As of September 30, the company's cash, cash equivalents and restricted cash was $7.4M. "It has been a busy and eventful quarter with progressive data analysis further reinforcing the strength of the ORCA-1 Phase 2b trial and the potential for cytisinicline as a new treatment for the millions of people who are battling nicotine addiction," commented Rick Stewart, chairman and CEO of Achieve. "Our key priority in the fourth quarter is to advance the ongoing, extensive preparations for the Phase 3 clinical trials, including our upcoming meeting with the FDA to finalize the cytisinicline Phase 3 protocols."

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$1.22 /

-0.08 (-6.15%)

06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
Hot Stocks
Achieve Life Sciences announces completion of MTD study » 05:43
09/30/19
09/30
05:43
09/30/19
05:43
ACHV

Achieve Life Sciences

$1.91 /

-0.04 (-2.05%)

Achieve Life Sciences…

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.

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$1.91 /

-0.04 (-2.05%)

06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
Conference/Events
Achieve Life Sciences to host investor day » 11:25
09/20/19
09/20
11:25
09/20/19
11:25
ACHV

Achieve Life Sciences

$2.21 /

+0.095 (+4.49%)

Investor day to be held…

Investor day to be held in New York on September 20 at 12 pm. Webcast Link

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$2.21 /

+0.095 (+4.49%)

06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
Conference/Events
Achieve Life Sciences to host investor day » 07:46
09/18/19
09/18
07:46
09/18/19
07:46
ACHV

Achieve Life Sciences

$2.23 /

-0.03 (-1.33%)

Investor day to be held…

Investor day to be held in New York on September 20 at 12 pm. Webcast Link

ShowHide Related Items >><<
ACHV Achieve Life Sciences
$2.23 /

-0.03 (-1.33%)

06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/14/19 Maxim
Achieve Life Sciences initiated with a Buy at Maxim
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg
06/11/19 Ladenburg
Achieve Life Sciences price target raised to $20 from $12 at Ladenburg

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.