ACHV Achieve Life Sciences
Price Chart
Executive Summary
Achieve Life Sciences presented comprehensive long-term safety data from the ORCA-OL study at ATS 2026, showing cytisinicline maintained a favorable safety profile over 52 weeks of continuous exposure with no new safety signals. The dataset completes the clinical evidence package supporting the NDA, which has a PDUFA date of June 20, 2026. This milestone de-risks the regulatory pathway for a potential first-in-class smoking cessation treatment addressing a large unmet need.
Actionable Insight
The ORCA-OL data remove a key regulatory risk by demonstrating long-term safety, increasing the probability of NDA approval. With the PDUFA date 32 days away, ACHV is a binary event play. Monitor for any FDA advisory committee meeting announcement or pre-approval inspection updates. The stock's historical T+20 win rate of 75% and strong positive alpha suggest the market has been rewarding positive catalysts.
Key Facts
- ORCA-OL study enrolled 475 adults using cigarettes, e-cigarettes, or both, with median 361 days of cytisinicline exposure
- No new safety signals identified by independent Data Safety Monitoring Committee over 52 weeks
- Nausea reported in only 2.5% of participants, consistent with Phase 3 rates
- 94.8% of adverse events were mild or moderate; only 5.7% discontinued due to treatment-related AEs
- NDA accepted for review with PDUFA date of June 20, 2026
- FDA granted Breakthrough Therapy designation and National Priority Voucher for e-cigarette/vaping cessation
Financial Impact
PDUFA catalyst on June 20, 2026; potential market of 25M US adult smokers and 18M e-cigarette users
Risk Factors
- FDA could issue a Complete Response Letter (CRL) on June 20, 2026, especially on CMC or labeling grounds
- Commercial launch execution risk if approved, given cytisinicline is a plant-based alkaloid with manufacturing complexity
- Competition from existing smoking cessation therapies (varenicline, NRT) and potential new entrants
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3297888 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 11, 2026
3d ago
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Institutional Cluster
| $5.83 awaiting T+1 | awaiting T+1 | — | $5.52 (+5.24%) |
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Jun 2, 2026
12d ago
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8-K
| $5.03 $4.92 | ▼ −2.19% | ▼ −1.49% | $5.52 (+9.74%) |
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May 22, 2026
24d ago
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EFFECT
| $4.69 $4.56 | ▲ +2.77% | ▲ +3.36% | $5.52 (−17.70%) |
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May 19, 2026
26d ago
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Press Release
| $4.45 $4.57 | ▲ +2.70% | ▲ +1.66% | $5.52 (+24.04%) |
|
May 12, 2026
4w ago
|
8-K
| $5.99 $5.96 | ▼ −0.50% | ▼ −1.08% | $5.52 (−7.85%) |
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May 12, 2026
4w ago
|
Press Release
| $5.99 $5.96 | ▼ −0.50% | ▼ −1.08% | $5.52 (−7.85%) |
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Apr 16, 2026
8w ago
|
8-K
| $5.10 $4.25 | ▲ +16.67% | ▲ +16.48% | $5.52 (−8.24%) |
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Apr 16, 2026
8w ago
|
Press Release
| $4.81 $5.10 | ▲ +6.03% | ▲ +4.81% | $5.52 (+14.76%) |
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Apr 15, 2026
8w ago
|
Press Release
| $3.55 $4.81 | ▲ +35.49% | ▲ +35.24% | $5.52 (+55.49%) |
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Mar 24, 2026
11w ago
|
Press Release
| $2.90 $2.82 | ▼ −2.76% | ▼ −3.33% | $5.52 (+90.34%) |
US Market Status
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