Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Partnerships Sopharma AD: license + supply agreements (mid-single digit royalties on Tabex-branded net sales in territory; $2.0M deferred consideration contingent on FDA/EMA approval via 2015 Extab share purchase); Adare Pharma Solutions: U.S.-based finished drug product manufacturer named for NDA resubmission and commercial supply (~$3.2M development agreements; Adare CEO Thomas Sellig is an Achieve board member)
Indications
Smoking cessation(Phase 3)
Nicotine e-cigarette (vaping) cessation(Phase 2)
Catalysts
— Q4 2026
— first half of 2027
Status note NDA for smoking cessation submitted Jun 2025, accepted Sep 2025 with PDUFA Jun 20, 2026. FDA issued Complete Response Letter Jun 2026 citing manufacturing-related observations at a third-party facility (OAI classification + warning letter) and incomplete final labeling; no efficacy or safety deficiencies identified. NDA resubmission planned Q4 2026 naming Adare; potential approval H1 2027. Filing states cytisinicline is the company's sole product candidate. Commissioner's National Priority Voucher (CNPV) awarded Oct 2025 for nicotine e-cigarette cessation. Sopharma filed an arbitration demand Jul 2026 alleging breach of the supply agreement over use of third-party manufacturers; company disputes it.
Per-asset detail extracted from the 10-Q filed 2026-08-11. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
Sponsor-matched active trials from ClinicalTrials.gov (1 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.
Institutional holder positions from 13F filings. Q/Q change is vs the prior quarter's filing; % of portfolio is the fund's own reported portfolio weight.
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