Achieve Life Sciences Shares Surge On Development Plan For Smoking Cessation Candidate

Achieve Life Sciences Inc ACHV shares are skyrocketing as the clinical-stage biotech moves one step closer to filing a New Drug Application for its smoking cessation pipeline candidate cytisine.

The stock was rallying 33.15 percent to $4.82 Wednesday morning. 

What Happened

After a meeting with the FDA regarding both clinical and non-clinical development plans for cytisine, Achieve Life Sciences said the Phase 3 clinical program as well as a future NDA filing are further defined.

In late June, the company reported positive results for cytisine based on a series of drug metabolism, drug-to-drug interaction and transponder studies.

Why It's Important

Cytisine is a plant-based alkaloid which binds to the nicotinic acetylcholine receptor. It has been approved and marketed in central and eastern Europe for over 15 years and has helped over 20 million people tackle nicotine addiction, according to Achieve. 

What's Next

The company said it will conduct a Phase 2b optimization trial in about 250 smokers in the U.S., with various dosing schedules to determine efficacy, safety and compliance profiles. The primary endpoint is a reduction in cigarettes consumed during treatment.

Achieve Life Sciences said it will initiate the Phase 2b trial in Q4'18, with top-line results expected in Q2'19. The results will help define the Phase 3 study, which is planned to be initiated in 2019.

Related Links:

The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Benzinga's Daily Biotech Pulse: Pfizer To Defer Price Hikes, Idera-BioCryst Merger Falls Through, ArQule To Offer Shares

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsFDATrading Ideassmoking cessation
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!