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Achieve Life Sciences Inc (ACHV)
NASDAQ:ACHV
Earnings Data
Report Date
Aug 07, 2025TBA Not Confirmed
Period Ending
2025 (Q2)Consensus EPS Forecast
-0.34Last Year’s EPS
-0.25Same Quarter Last Year
Strong Buy
Based on 4 Analysts Ratings
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Earnings Call Summary
Earnings Call Date:May 13, 2025
|% Change Since: 33.47%
|Next Earnings Date:Aug 07, 2025
Earnings Call Sentiment|Positive
The call highlighted Achieve's progress towards NDA submission for cytisinicline, with significant milestones in clinical trials and strong financial management. Despite a reported net loss, the overall tone was optimistic with potential future challenges in commercialization timing.Company Guidance
During the Achieve Life Sciences Q1 2025 earnings call, key guidance was provided on the company's progress, particularly focusing on the upcoming NDA submission for cytisinicline, projected for June 2025. Achieve is targeting approval within 12 months post-submission. The open label ORCA-OL trial has shown encouraging results, with over 100 patients completing the FDA-required one-year exposure, reflecting cytisinicline's tolerability and potential efficacy. Approximately 75% of the 479 participants remain on treatment, indicating strong adherence. Financially, the company reported operating expenses of $12.9 million and a net loss of $12.8 million for the first quarter, ending March 31, 2025, with $23.2 million in cash, cash equivalents, and marketable securities. Achieve is keen on managing resources efficiently to extend its cash runway while preparing for a potential commercial launch in 2026.NDA Submission Imminent
Achieve is on track to submit the NDA for cytisinicline next month, marking a significant milestone for the company.
ORCA-OL Trial Progress
Over 100 patients have one-year exposure to cytisinicline as required by the FDA, with 75% of participants remaining on treatment, indicating its tolerability and potential efficacy.
Publication and Recognition
ORCA-3 trial results were published in JAMA Internal Medicine, highlighting cytisinicline's efficacy and tolerability in quitting smoking.
Financial Management
Achieve ended the quarter with $23.2 million in cash, emphasizing strong financial discipline in preparation for the NDA submission and future launch.
Strong Advisory Support
A Scientific Advisory Board meeting with experts from renowned institutions showed significant enthusiasm for cytisinicline.
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ACHV Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
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ACHV Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 13, 2025 | $2.48 | $2.65 | +6.85% |
Mar 11, 2025 | $3.06 | $2.92 | -4.58% |
Nov 07, 2024 | $5.00 | $4.63 | -7.40% |
Aug 13, 2024 | $4.36 | $4.38 | +0.46% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
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FAQ
When does Achieve Life Sciences Inc (ACHV) report earnings?
Achieve Life Sciences Inc (ACHV) is schdueled to report earning on Aug 07, 2025, TBA Not Confirmed.
What is Achieve Life Sciences Inc (ACHV) earnings time?
Achieve Life Sciences Inc (ACHV) earnings time is at Aug 07, 2025, TBA Not Confirmed.
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is ACHV EPS forecast?
ACHV EPS forecast for the fiscal quarter 2025 (Q2) is -0.34.
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