Overview

* Achieve Q3 net loss and EPS missed analyst expectations

* FDA accepted NDA for cytisinicline in smoking cessation, PDUFA date set for June 2026

* Awarded FDA Commissioner's National Priority Voucher for vaping cessation

Outlook

* Company confirms PDUFA action date for cytisinicline as June 20, 2026

* Achieve awarded FDA Priority Voucher for vaping cessation

* Company highlights unmet need in vaping cessation market

Result Drivers

* Total operating expenses for the three and nine months ended September 30, 2025, were $14.7 million and $40.1 million, respectively

Key Details

Metric Beat/Mis Actual Consensu

s s

Estimate

Q3 EPS Miss -$0.28 -$0.26

(7

Analysts

)

Q3 Net Miss -$14.44 -$12.20

Income mln mln (7

Analysts

)

Q3 Miss -$14.69 -$12.10

Income mln mln (7

From Analysts

Operatio )

ns

Q3 $14.69

Operatin mln

g

Expenses

Analyst Coverage

* The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 7 "strong buy" or "buy", no "hold" and no "sell" or "strong sell"

* The average consensus recommendation for the biotechnology & medical research peer group is "buy"

* Wall Street's median 12-month price target for Achieve Life Sciences Inc ( ACHV ) is $13.00, about 62.1% above its November 5 closing price of $4.93

Press Release:

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(This story was created using Reuters automation and AI based on LSEG and company data. It was checked and edited by a Reuters journalist prior to publication.)