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SEATTLE - Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported fourth quarter earnings that fell short of analyst expectations, sending shares down 4.9% in response. The late-stage pharmaceutical company, focused on developing cytisinicline for smoking cessation, posted a quarterly loss of $0.36 per share, $0.02 worse than the consensus estimate of a $0.34 loss.
For the fourth quarter, Achieve Life Sciences reported total operating expenses of $12.2 million and a net loss of $12.4 million. The company ended 2024 with $34.4 million in cash, cash equivalents, and marketable securities.
Despite the earnings miss, Achieve Life Sciences reiterated its plans to submit a new drug application (NDA) for cytisinicline to the U.S. Food and Drug Administration by the end of the second quarter of 2025. The company has completed enrollment in its ORCA-OL long-term exposure trial, meeting the requirement of 300 participants receiving six months of cumulative cytisinicline treatment needed for the NDA submission.
"We are thrilled with our progress to date and excited to have the NDA submission on track for the end of next quarter, furthering our mission to bring cytisinicline to market as the first new FDA-approved nicotine dependence treatment in nearly 20 years," said Rick Stewart, Achieve’s Chief Executive Officer.
The company also announced positive outcomes from two data safety monitoring committee reviews of the ORCA-OL trial, with no safety concerns identified. Additionally, Achieve Life Sciences recently appointed two new board members and a new Chief Financial Officer to support its strategic initiatives and potential commercialization efforts.
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