企業プロフィール
Achieve Life Sciences 株価・ニュース・カタリスト
- ティッカー:
- ACHV
- 取引所:
- NASDAQ
- セクター:
- Life Science Tools
- 所在地:
- United States
株価パフォーマンス
7.50 USD (-1.19%)
終値
最終更新: 2026年8月17日
516M USD
時価総額
株価変動の要因
As of Aug 17, 2026, ACHV closed down 1.19% at $7.50. No new same-company headline was identified in the current news window.
企業概要
Nicotine Dependence Company
Achieve Life Sciences develops cytisinicline as a treatment for nicotine dependence and smoking cessation.
Cytisinicline
Cytisinicline is a plant-derived partial agonist of the nicotinic acetylcholine receptor and is intended as a shorter-course alternative to existing prescription therapies.
Phase 3 Evidence
The ORCA-2 and ORCA-3 studies demonstrated higher continuous abstinence rates than placebo, including in participants previously treated with varenicline or bupropion.
Manufacturing Transition
After FDA inspection findings at a prior third-party facility affected the NDA review, Achieve moved finished-drug-product manufacturing to U.S.-based Adare Pharma Solutions. The FDA's complete response letter did not identify deficiencies in cytisinicline's clinical efficacy or safety.
今後のカタリスト
- Resubmission of the cytisinicline NDA with Adare as the finished-drug-product manufacturer in the fourth quarter of 2026.
- Potential FDA approval of cytisinicline in the first half of 2027, followed by a U.S. commercial launch.
最近のニュース
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類似銘柄
事業成熟度、治療領域、カタリスト傾向が近い同業銘柄です。