Achieve Life Sciences, Inc. - ACHV STOCK NEWS

Achieve Life Sciences (ACHV) announced its Q2 2022 financial results, highlighting significant milestones in its clinical program for cytisinicline.

The Phase 3 ORCA-2 trial showed statistically significant results with increased quit rates, 6-8 times higher than placebo. The company was also awarded a $2.5 million NIH grant for the ORCA-V1 Phase 2 trial targeting nicotine e-cigarette users. Financially, Achieve reported a net loss of $10.5 million for Q2, with cash reserves of $29.4 million as of June 30, 2022. A conference call is scheduled for August 11, 2022, at 4:30 PM EDT.

Achieve Life Sciences (NASDAQ: ACHV) will release its second quarter financial results on August 11, 2022, at 4:30 PM EDT. The focus will be on the development of cytisinicline, a plant-based treatment for smoking cessation. Tobacco-related diseases result in over 8 million deaths globally each year. Cytisinicline aims to address nicotine addiction by acting on brain receptors to ease withdrawal symptoms and reduce cravings. The product is still under investigation and has not yet received FDA approval.

Achieve Life Sciences (Nasdaq: ACHV) announced the issuance of stock options to two new employees as inducement grants. The Board approved a total of 15,000 shares for purchase on June 29, 2022. This action aligns with Nasdaq Listing Rule 5635(c)(4), emphasizing the company's commitment to attracting talent. The options will vest over four years, starting with 25% after the first year of employment. Achieve focuses on developing cytisinicline for smoking cessation, targeting a significant public health issue amid the global nicotine addiction epidemic.

Achieve Life Sciences (Nasdaq: ACHV) has initiated subject screening for its ORCA-V1 Phase 2 clinical trial, testing 3mg cytisinicline in 150 adult e-cigarette users across five U.S. locations. Funded by a $2.8 million grant from the National Institute on Drug Abuse, the trial will assess efficacy versus placebo over 12 weeks. The ORCA-2 trial previously yielded positive results, showing up to eight times higher quit rates for smokers using cytisinicline compared to placebo. Achieve is also advancing its Phase 3 ORCA-3 trial targeting combustible cigarette cessation.

Achieve Life Sciences has received a $2.5 million grant from the National Institute on Drug Abuse (NIDA) to fund the initiation of the Phase 2 ORCA-V1 clinical trial. This trial will assess the efficacy and safety of cytisinicline in around 150 adult users of nicotine e-cigarettes at five locations in the U.S. The total awarded funding now amounts to $2.8 million, covering about half the trial's costs. Notably, cytisinicline has shown promising results in previous studies, and there is a significant market opportunity as over 10 million U.S. adults use e-cigarettes.

Achieve Life Sciences (NASDAQ: ACHV) is set to participate in the LD Micro Invitational Conference from June 7-9, 2022, at the Four Seasons in Westlake Village, CA. The presentation scheduled for June 7 at 7:30 AM PDT will also be available for virtual viewing. Achieve focuses on developing cytisinicline, a plant-based compound aimed at aiding smoking cessation and addressing nicotine addiction. Tobacco use causes over 8 million deaths globally each year, highlighting the significance of Achieve's mission. Cytisinicline has not yet received FDA approval.

Achieve Life Sciences (NASDAQ: ACHV), a clinical-stage pharmaceutical firm, will participate in the Spring Into Action Best Ideas Virtual Investor Conference from May 16-20, 2022. Achieve focuses on the development of cytisinicline, a plant-based product aimed at smoking cessation and nicotine addiction. This investigational candidate has not yet received FDA approval. With tobacco-related deaths exceeding eight million globally, cytisinicline aims to mitigate this crisis by targeting nicotine receptors in the brain. For access to the conference, registration is required.

Achieve Life Sciences (Nasdaq: ACHV) reported strong first quarter 2022 results, highlighting significant outcomes from the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation. The trial showed a 32.6% abstinence rate at weeks 9-12 for those on cytisinicline, compared to 7.0% for placebo. The company gained access to an additional $10 million in funding via a revised agreement with Silicon Valley Bank. Achieve ended the quarter with $36.4 million in cash and reported a net loss of $7.6 million on operating expenses of $7.2 million.

Achieve Life Sciences (NASDAQ: ACHV) announced positive topline results from the Phase 3 ORCA-2 trial for cytisinicline, showing significant efficacy in smoking cessation. Participants receiving 12 weeks of treatment demonstrated a 6.3x higher likelihood of quitting smoking compared to placebo, while those receiving 6 weeks showed an 8x increase. Continuous abstinence rates were 21.1% and 8.9% respectively after treatment. The trial highlighted cytisinicline's safety with low adverse event rates. Achieve is seeking FDA approval for this potential breakthrough in smoking cessation therapy.