AQST

Price & events

Pipeline stages · 1 programs

Pipeline · 1 trials · 1 upcoming

Catalyst news & presentations · 19

• 2026Guided 40%regulatory submissionFiled (NDA/BLA)Anaphylm · Regulatory applications for Anaphylm in Canada and EU.SEC 8-K
• Q3 2026Guided 70%regulatory submissionFiled (NDA/BLA)Anaphylm · Resubmission of NDA for Anaphylm in patients >= 30 kg.SEC 8-K
• as early as the third quarter of 2026Guided 70%regulatory submissionFiled (NDA/BLA)Anaphylm (dibutepinephrine) · Expected resubmission of NDA to address packaging and administration deficiencies.SEC 8-K
• 2026-08-11Estimated 45%earningsEarningsEarnings releaseyahoo
• first half of 2026trial initiationsecondaryAQST-108 · Begin clinical study for AQST-108SEC 8-K
• 2026-03-30fda agreementAnaphylm™ (dibutepinephrine) · Successful completion of an in-person Type A FDA meeting regarding NDA resubmission.SEC 8-K
• 2026-03-03partnershipAnaphylm · Extends revenue sharing agreement with RTW Investments to June 30, 2027.SEC 8-K
• January 31, 2026PDUFAPDUFAAnaphylm (dibutepinephrine) · PDUFA target action date for AnaphylmSEC 8-K
• 2026-01-30crlAnaphylm (dibutepinephrine) · FDA cited deficiencies limited to packaging and administration for the NDA.SEC 8-K
• 2026-01-30crlAnaphylm · FDA cites human factors validation deficiencies for NDA in patients >= 30 kg.SEC 8-K
• fourth quarter of 2025regulatory submissionFiled (NDA/BLA)AQST-108 · Submit IND to FDA for AQST-108 topical epinephrine gelSEC 8-K
• 2025-09-04fda agreementAnaphylm (dibutepinephrine) · FDA informed company that an advisory committee meeting is not required for AnaphylmSEC 8-K
• 2025-08-13partnershipAnaphylm · Funding agreement with RTW for up to $75M upon FDA approval and other conditionsSEC 8-K
• before the end of the second quarter of 2025filing acceptanceFiled (NDA/BLA)Anaphylm · Expected FDA acceptance of NDASEC 8-K
• second quarter of 2025trial initiationsecondaryPhase 2AQST-108 · Phase 2a clinical trial beginsSEC 8-K
• first quarter of 2025regulatory submissionFiled (NDA/BLA)Anaphylm · NDA submission for Anaphylm (epinephrine) Sublingual FilmSEC 8-K
• February 28 - March 3, 2025conferencedata presentationsecondaryAnaphylm · Multiple presentations at AAAAI Annual MeetingSEC 8-K
• fourth quarter of 2024trial initiationsecondaryAnaphylm · Initiate pediatric study in subjects weighing 30 kg and aboveSEC 8-K
• 2024-12-02fda agreementAnaphylm · Received positive feedback from FDA prior to NDA submissionSEC 8-K