Achieve Life Sciences Inc Stock Price, News & Analysis

Achieve Life Sciences (NASDAQ: ACHV) announced the allowance of two U.S. patent applications covering a novel 3.0 mg three times daily cytisinicline dosing regimen for nicotine addiction treatment. These patents will protect the administration method, potentially enhancing its intellectual property strategy as cytisinicline undergoes clinical trials. The Phase 3 ORCA-2 trial is ongoing, with a 50% quit rate observed in prior studies. Patents are expected to expire in Q3 2040, and the company aims for FDA approval, which could link the patents to the FDA's Orange Book.

Achieve Life Sciences, a clinical-stage pharmaceutical company, will participate in the LD Micro Invitational XI Conference from June 8-10, 2021. CEO John Bencich is set to present virtually on June 9 at 2:30 p.m. EDT. The event will feature around 180 companies and will run daily from 10 a.m. to 6 p.m. EDT. Achieve is focused on developing cytisinicline for smoking cessation, a plant-based alkaloid that assists with nicotine addiction. Currently, a Phase 3 study (ORCA-2) is enrolling participants across 17 U.S. sites.

Achieve Life Sciences (Nasdaq: ACHV) has successfully closed a public offering, issuing 3,285,714 shares of common stock at a price of $7.00 per share. This results in gross proceeds of $23.0 million destined for ongoing development of cytisinicline, clinical research, and corporate purposes. The offering included 428,571 additional shares from underwriters' exercised options. The securities were registered with the SEC, and the company continues to focus on combating nicotine addiction through its investigational product, cytisinicline, currently in Phase 3 trials.

Achieve Life Sciences (NASDAQ: ACHV) has announced a public offering of 2,857,143 shares of its common stock at $7.00 per share, aiming to raise approximately $20 million. The offering is slated to close on or around May 27, 2021. Proceeds will be allocated to the ongoing development of cytisinicline, clinical research, and general corporate purposes. The offering is managed by Oppenheimer & Co. Inc. and Lake Street Capital Markets. A registration statement has been filed and declared effective by the SEC.

Achieve Life Sciences (NASDAQ:ACHV) has announced a proposed underwritten public offering of its common stock, including a 30-day option for underwriters to purchase an additional 15%. The company plans to utilize proceeds for ongoing development of cytisinicline, a treatment for smoking cessation, along with other corporate purposes. The offering is subject to market conditions, and there is no guarantee regarding its timing or completion. Oppenheimer & Co. is the sole book-running manager for the offering.

Achieve Life Sciences (NASDAQ:ACHV) reported Q1 2021 financial results, revealing a net loss of $8.0 million on total operating expenses of $8.0 million. As of March 31, 2021, the company's cash reserves totaled $29.7 million. The Phase 3 ORCA-2 trial for cytisinicline is progressing with enrollment expected to complete by mid-2021. Promising results from the Phase 2b ORCA-1 trial showed significant smoking cessation benefits. Additionally, cytisinicline demonstrated non-inferiority to Chantix in the RAUORA trial. New board members, Dr. Martell and Dr. Jacobs, were appointed, enhancing leadership expertise.

Achieve Life Sciences, Inc. (Nasdaq:ACHV) will announce its first quarter 2021 financial results and provide updates on the cytisinicline development program on May 13, 2021, at 4:30 PM EDT. Interested parties can join the live webcast via the company's Investor Relations page or by calling (877) 472-9809 in the U.S. and Canada. A replay will be available after the call, archived for 90 days.

Achieve Life Sciences, Inc. (NASDAQ: ACHV) will host a Virtual Non-Deal Roadshow on April 27, 2021, at 9:00 AM EDT. CEO John Bencich will present the company’s plans and participate in a Q&A with Zacks Analyst John Vandermosten. This event aims to inform on Achieve’s development of cytisinicline, a plant-based treatment for smoking cessation, which is currently in a Phase 3 clinical trial (ORCA-2) involving 750 subjects across 16 U.S. sites. Cytisinicline targets nicotine addiction by interacting with brain receptors. For more details, visit Achieve's website.

Achieve Life Sciences (ACHV) announces the publication of Phase 2b ORCA-1 trial results, demonstrating that cytisinicline is statistically significantly more effective than placebo in aiding smoking cessation. Participants on the 3.0 mg cytisinicline thrice daily regimen were 5 times more likely to achieve abstinence (p<0.001). The drug showed a favorable safety profile with no serious adverse events reported. The ongoing Phase 3 ORCA-2 trial is currently enrolling participants across 16 sites in the U.S. for further evaluation of cytisinicline's effectiveness.