September 2026 Catalyst Events
- 2026-09-01: Rhapsido (Remibrutinib) - (REMODEL-1) — Novartis AG — End of Phase Meeting
- 2026-09-01: envudeucitinib (ESK-001) - (LUMUS) — Alumis Inc. — Phase 2b
- 2026-09-01: Halneuron - (HALT-CINP / HAL-CINP-203) — Dogwood Therapeutics Inc. — Conference Presentation
- 2026-09-02: ACI-19764 — AC Immune SA — Initial Data
- 2026-09-02: BiPASS (Illuccix) — Teleflex Incorporated — Phase 3
- 2026-09-02: Ivonescimab (SMT112) with chemotherapy - (HARMONi-2) — Summit Therapeutics Inc. — Regulatory Decision
- 2026-09-02: GENGLYCOS (pariglasgene brecaparvovec-opnr) — Ultragenyx Pharmaceutical Inc. — Phase 3
- 2026-09-02: GTX-102 - (Aspire) — Ultragenyx Pharmaceutical Inc. — Phase 3
- 2026-09-02: Lanifibranor - (NATiV3) — Inventiva S.A. — Submission
- 2026-09-02: RASONQUE (Daraxonrasib (RMC-6236)0 — Revolution Medicines Inc - Ordinary Shares — Phase 1/2
- 2026-09-02: RASONQUE (Daraxonrasib (RMC-6236)) vs. Docetaxel - (RASolve-301) — Revolution Medicines Inc - Ordinary Shares — Phase 1/2
- 2026-09-02: Paxalisib — Kazia Therapeutics Limited — Preclinical
- 2026-09-02: Apitegromab - (FORGE) — Scholar Rock Holding Corporation — Phase 2
- 2026-09-02: TSC-101 - (ALLOHA-2) — TScan Therapeutics Inc. — Phase 3
- 2026-09-02: TEV '408 — Teva Pharmaceutical Industries Limited American Depositary Shares — End of Phase Meeting
- 2026-09-02: TYVASO (treprostinil) - (TETON) — United Therapeutics Corporation — Regulatory Decision
- 2026-09-02: Namodenoson (CF102) — Can-Fite Biopharma Ltd American Depositary Shares each representing two (2) — Interim Data
- 2026-09-02: AMT-130 — uniQure N.V. — Submission
- 2026-09-03: Etentamig (ABBV-383) - (CERVINO) — AbbVie Inc. — End of Phase Meeting
- 2026-09-03: Mipletamig in combination with venetoclax and azacitidine - (RAINIER) — Aptevo Therapeutics Inc. — Interim Data
- 2026-09-03: Bradykinin B2 receptor - (CHAPTER-1) — Pharvaris N.V. — Phase 2
- 2026-09-03: CLYM116 - (NAVIGATE-2) — Climb Bio Inc. — End of Phase Meeting
- 2026-09-03: YUTREPIA (treprostinil) inhalation powder - (RE-WARM) — Liquidia Corporation — Phase 2a
- 2026-09-03: CLYM116 — Climb Bio Inc. — Initial Data
- 2026-09-04: ZANVASTRO (zilganersen) — Ionis Pharmaceuticals Inc. — Approved
- 2026-09-06: EPX-100 - (ARGUS) — Harmony Biosciences Holdings Inc. — Conference Presentation
- 2026-09-06: ARIKAYCE - (ENCORE) — Insmed Incorporated — Conference Presentation
- 2026-09-06: GRI-0621-IPF-02 — GRI Bio Inc. — Conference Presentation
- 2026-09-07: Azetukalner (XEN1101) - (X-TOLE2) — Xenon Pharmaceuticals Inc. — Conference Presentation
- 2026-09-08: BEAM-302 — Beam Therapeutics Inc. — Conference Presentation
- 2026-09-08: BEAM-302 — Beam Therapeutics Inc. — Conference Presentation
- 2026-09-09: OPGx-BEST1 - (BIRD-1) — Opus Genetics Inc. — Topline Data
- 2026-09-09: XP-8121 (levothyroxine sodium) — Xeris Biopharma Holdings Inc. — Conference Presentation
- 2026-09-10: DISC-3405 - (RESTORE-PV) — Disc Medicine Inc. — Conference Presentation
- 2026-09-11: α-lactalbumin — Anixa Biosciences Inc. — Conference Presentation
- 2026-09-11: TLX101-Px — Telix Pharmaceuticals Limited — Regulatory Decision
- 2026-09-11: TLX101-Px — Telix Pharmaceuticals Limited — Regulatory Decision
- 2026-09-15: Efzofitimod - (EFZO-FIT) — aTyr Pharma Inc. — End of Phase Meeting
- 2026-09-15: ABBV-706 — AbbVie Inc. — Conference Presentation
- 2026-09-15: ABBV-1480 (RC148) — AbbVie Inc. — Conference Presentation
- 2026-09-18: OPGx-BEST1 - (BIRD-1) — Opus Genetics Inc. — Topline Data
- 2026-09-18: OPGx-BEST1 - (BIRD-1) — Opus Genetics Inc. — Topline Data
- 2026-09-18: Zidesamtinib (NVL-520) - (ARROS-1) — Nuvalent Inc. — Conference Presentation
- 2026-09-19: UX111 - (ABO-102) — Ultragenyx Pharmaceutical Inc. — Regulatory Decision
- 2026-09-21: WINREVAIR (sotatercept-csrk) - (HYPERION) — Merck & Company Inc. — Regulatory Decision
- 2026-09-21: WINREVAIR (sotatercept-csrk) - (HYPERION) — Merck & Company Inc. — Regulatory Decision
- 2026-09-22: RAP-219 — Rapport Therapeutics Inc. — Conference Presentation
- 2026-09-22: Zilganersen (ION373) — Ionis Pharmaceuticals Inc. — Regulatory Decision
- 2026-09-23: IMNN-001 - (OVATION 3) — Imunon Inc. — Conference Presentation
- 2026-09-23: DT120 ODT (MM120) lysergide tartrate - (Panorama) — Definium Therapeutics Inc. — Topline Data
- 2026-09-23: DURAVYU (EYP-1901) - (LUGANO) — EyePoint Inc. — Conference Presentation
- 2026-09-24: DURAVYU (EYP-1901) - (LUGANO) — EyePoint Inc. — Conference Presentation
- 2026-09-24: AXPAXLI (OTX-TKI) - (SOL-1) — Ocular Therapeutix Inc. — Conference Presentation
- 2026-09-24: OCU410 - (ArMaDa) — Ocugen, Inc. — Conference Presentation
- 2026-09-25: Cemsidomide (CFT7455) in combination with Dexamethasone - (MOMENTUM) — C4 Therapeutics Inc. — Conference Presentation
- 2026-09-25: Tambiciclib (SLS009) (GFH009) with venetoclax — SELLAS Life Sciences Group Inc. — Conference Presentation
- 2026-09-26: Zilurgisertib (INCB000928) - (PROGRESS) — Mirum Pharmaceuticals Inc. — Regulatory Decision
- 2026-09-26: Zilurgisertib (INCB000928) - (PROGRESS) — Incyte Corporation — Regulatory Decision
- 2026-09-27: Relutrigine (PRAX-562) - (EMBOLD) — Praxis Precision Medicines Inc. — Regulatory Decision
- 2026-09-28: CMP-002 (CMP-SYNGAP-01) — CAMP4 Therapeutics Corporation — Initial Data
- 2026-09-28: Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series — Biofrontera Inc. — Regulatory Decision
- 2026-09-29: AL001-BD01 - (Lithium in Brain) — Alzamend Neuro Inc. — Conference Presentation
- 2026-09-29: Aglatimagene besadenovec (CAN-2409) - (ULYSSES) — Candel Therapeutics Inc. — Conference Presentation
- 2026-09-29: Aglatimagene besadenovec (CAN-2409) - (ULYSSES) — Candel Therapeutics Inc. — Conference Presentation
- 2026-09-30: OST-HER2 (AOST-2121) — OS Therapies Incorporated — Submission
- 2026-09-30: Bezisterim (NE3107) - (ADDRESS-LC) — BioVie Inc. — Topline Data
- 2026-09-30: TYRA-300 - (SURF302) — Tyra Biosciences Inc. — Initial Data
- 2026-09-30: Apitegromab - (SAPPHIRE) — Scholar Rock Holding Corporation — Regulatory Decision
- 2026-09-30: ORKA-001 - (EVERLAST-A) — Oruka Therapeutics Inc. — Interim Data
- 2026-09-30: SCY-247 — SCYNEXIS Inc. — Topline Data
- 2026-09-30: CNM-Au8 - (HEALEY ALS) — Clene Inc. — Submission
- 2026-09-30: SCY-770 (PXL-770) — SCYNEXIS Inc. — Topline Data
- 2026-09-30: OST-HER2 (AOST-2121) — OS Therapies Incorporated — Submission
- 2026-09-30: Low-dose infigratinib - (PROPEL3) — BridgeBio Pharma Inc. — Submission
- 2026-09-30: Anaphylm (dibutepinephrine) - (103) — Aquestive Therapeutics Inc. — Submission
- 2026-09-30: Rademikibart - (Seabreeze STAT Asthma) — Connect Biopharma Holdings Limited — Topline Data
- 2026-09-30: Seralutinib (GB002) - (TORREY/PROSERA) — Ligand Pharmaceuticals Incorporated — End of Phase Meeting
- 2026-09-30: GR-MD-02 (belapectin) - (NAVIGATE) — Galectin Therapeutics Inc. — Submission
- 2026-09-30: Tarcocimab tedromer (KSI-501) - (DAYBREAK) — Kodiak Sciences Inc — Topline Data
- 2026-09-30: Laromestrocel (lomecel-B) - (ELPIS II) — Longeveron Inc. — Topline Data
- 2026-09-30: ESK-001 - (LUMUS) — Alumis Inc. — Topline Data
- 2026-09-30: VYD2311 - (LIBERTY) — Invivyd Inc. — Topline Data
- 2026-09-30: VYD2311 - (DECLARATION) — Invivyd Inc. — Topline Data
- 2026-09-30: BDC-4182 — Bolt Biotherapeutics Inc. — Initial Data
- 2026-09-30: Miv-cel (mivocabtagene autoleucel, KYV-101) - (KYSA-6) — Kyverna Therapeutics Inc. — Topline Data
- 2026-09-30: Halneuron - (HALT-CINP / HAL-CINP-203) — Dogwood Therapeutics Inc. — Topline Data
- 2026-09-30: OST-HER2 (AOST-2121) — OS Therapies Incorporated — Submission
- 2026-09-30: ADI-212 — Adicet Bio Inc. — Submission
- 2026-09-30: DT120 ODT (MM120) lysergide tartrate - (Panorama) — Definium Therapeutics Inc. — Topline Data
- 2026-09-30: Miv-cel (mivocabtagene autoleucel, KYV-101) - (KYSA-8) — Kyverna Therapeutics Inc. — Topline Data
- 2026-09-30: ERNA-101 — Ernexa Therapeutics Inc. — Submission
- 2026-09-30: Barzolvolimab (CDX-0159) - (EMBARQ-CSU1) — Celldex Therapeutics Inc. — Topline Data
- 2026-09-30: Aleniglipron (GSBR-1290) - (ACCESS and ACCESS II ) — Structure Therapeutics Inc. — Topline Data
- 2026-09-30: Nanobody sonelokimab - (IZAR-1) — MoonLake Immunotherapeutics — Submission
- 2026-09-30: TX2100 — Tectonic Therapeutic Inc. — Topline Data
- 2026-09-30: ACCG-2671 — Structure Therapeutics Inc. — Initial Data
- 2026-09-30: Barzolvolimab (CDX-0159) - (EMBARQ-CSU2) — Celldex Therapeutics Inc. — Topline Data
- 2026-09-30: Apitegromab - (SAPPHIRE) — Scholar Rock Holding Corporation — Regulatory Decision
- 2026-09-30: EVO756 — Evommune Inc. — Initial Data
- 2026-09-30: DT120 ODT (MM120) lysergide tartrate - (Panorama) — Definium Therapeutics Inc. — Topline Data
- 2026-09-30: Brelovitug - (AZURE) — Mirum Pharmaceuticals Inc. — Topline Data
- 2026-09-30: BMF-650 (GLP-131) — Biomea Fusion Inc. — Initial Data
- 2026-09-30: CLN-978 - (OUTRACE RA) — Cullinan Therapeutics Inc. — Initial Data
- 2026-09-30: CTX-009 - (COMPANION-003) — Compass Therapeutics Inc. — End of Phase Meeting
- 2026-09-30: Avexitide (Exendin 9-39) - (LUCIDITY) — Amylyx Pharmaceuticals Inc. — Initial Data
- 2026-09-30: CRB-913 - (CANYON-1) — Corbus Pharmaceuticals Holdings Inc. — Topline Data
- 2026-09-30: Prulacabtagene leucel (prula-cel, formerly ADI-001) — Adicet Bio Inc. — Interim Data
- 2026-09-30: UGN-103 - (UTOPIA) — UroGen Pharma Ltd. — Submission
- 2026-09-30: CRB-913 - (CANYON-1) — Corbus Pharmaceuticals Holdings Inc. — Topline Data
- 2026-09-30: VK2735 (Maintainance Dosing) — Viking Therapeutics Inc. — Initial Data
- 2026-09-30: VK2735 (Oral) - (VENTURE) — Viking Therapeutics Inc. — Interim Data
- 2026-09-30: DISC-3405 - (RESTORE-PV) — Disc Medicine Inc. — Initial Data
- 2026-09-30: VK2735 - (VANQUISH-2) — Viking Therapeutics Inc. — Interim Data
- 2026-09-30: AMT-130 — uniQure N.V. — Topline Data
- 2026-09-30: AMT-130 - (Europe Trial) — uniQure N.V. — Topline Data
- 2026-09-30: Seralutinib (GB002) - (TORREY/PROSERA) — Ligand Pharmaceuticals Incorporated — End of Phase Meeting
- 2026-09-30: Efgartigimod - (ALKIVIA) — argenx SE — Topline Data
- 2026-09-30: Apitegromab - (SAPPHIRE) — Scholar Rock Holding Corporation — Regulatory Decision
- 2026-09-30: Remlifanserin (ACP-204) - (RADIANT) — ACADIA Pharmaceuticals Inc. — Topline Data
- 2026-09-30: Halneuron - (HALT-CINP / HAL-CINP-203) — Dogwood Therapeutics Inc. — Topline Data
- 2026-09-30: Viaskin Peanut - (VITESSE) — DBV Technologies S.A. — Submission
- 2026-09-30: ERNA-101 — Ernexa Therapeutics Inc. — Submission
- 2026-09-30: ERNA-101 — Ernexa Therapeutics Inc. — Submission
- 2026-09-30: Eftilagimod alpha (efti) - (TACTI-004/KEYNOTE-F91) — Immutep Limited — Full Results
- 2026-09-30: VOXZOGO - (ASPEN) — BioMarin Pharmaceutical Inc. — Submission
- 2026-09-30: SCY-770 (PXL-770) — SCYNEXIS Inc. — Topline Data
- 2026-09-30: MN-001 (Tipelukast) - (NATG-202) — MediciNova Inc. — Topline Data
- 2026-09-30: BMF-650 (GLP-131) — Biomea Fusion Inc. — Initial Data
- 2026-09-30: Viaskin Peanut - (VITESSE) — DBV Technologies S.A. — Submission
- 2026-09-30: Low-dose infigratinib - (PROPEL3) — BridgeBio Pharma Inc. — Submission
- 2026-09-30: CT-95 (mesothelin) — Context Therapeutics Inc. — Initial Data
- 2026-09-30: VK2735 — Viking Therapeutics Inc. — Initial Data
- 2026-09-30: GR-MD-02 (belapectin) - (NAVIGATE) — Galectin Therapeutics Inc. — Submission
- 2026-09-30: RGX-202 - (AFFINITY DUCHENNE) — REGENXBIO Inc. — Submission
- 2026-09-30: Revita - (REMAIN-1) — Fractyl Health, Inc. — Interim Data
- 2026-09-30: Nanobody (sonelokimab) - (VELA-1) — MoonLake Immunotherapeutics — Submission
- 2026-09-30: Nanobody (sonelokimab) - (VELA-2) — MoonLake Immunotherapeutics — Submission
- 2026-09-30: Anaphylm (dibutepinephrine) - (103) — Aquestive Therapeutics Inc. — Submission
- 2026-09-30: TX2100 — Tectonic Therapeutic Inc. — Topline Data
- 2026-09-30: SCY-247 — SCYNEXIS Inc. — Topline Data
- 2026-09-30: BDC-4182 — Bolt Biotherapeutics Inc. — Initial Data
- 2026-09-30: REYOBIQ (rhenium Re186 obisbemeda) - (ReSPECT-LM) — PLUS THERAPEUTICS Inc. — End of Phase Meeting
- 2026-09-30: Nintedanib Dpi (Mnkd-201) - (INFLO-1) — MannKind Corporation — Interim Data
- 2026-09-30: PMN310 - (PRECISE-AD) — ProMIS Neurosciences Inc. — Topline Data
- 2026-09-30: ABCL635 — AbCellera Biologics Inc. — Topline Data
- 2026-09-30: OPGx-BEST1 — Opus Genetics Inc. — Full Results
- 2026-09-30: CYWC628 — FibroBiologics Inc. — Initial Data
- 2026-09-30: NXC-201 (HBI10101) - (NEXICART-2) — Immix Biopharma Inc. — Full Results
- 2026-09-30: AL001-BD01 - (Lithium in Brain) — Alzamend Neuro Inc. — Initial Data
- 2026-09-30: Foralumab - (INFORM-MS) — Tiziana Life Sciences Ltd — Topline Data
- 2026-09-30: VK2735 - (VENTURE) — Viking Therapeutics Inc. — Interim Data
- 2026-09-30: SPY072 - (SKYWAY-RD, basket study) — Spyre Therapeutics Inc. — Topline Data
- 2026-09-30: Bezisterim (NE3107) - (ADDRESS-LC) — BioVie Inc. — Topline Data
- 2026-09-30: Pemvidutide - (RECLAIM) — Altimmune Inc. — Topline Data
- 2026-09-30: SPY001, SPY002, SPY003 - (SKYLINE) — Spyre Therapeutics Inc. — Interim Data
- 2026-09-30: Bezisterim (NE3107) - (SUNRISE-PD) — BioVie Inc. — Topline Data
- 2026-09-30: MN-001 (Tipelukast) - (NATG-202) — MediciNova Inc. — Topline Data
- 2026-09-30: Rademikibart - (Seabreeze STAT Asthma) — Connect Biopharma Holdings Limited — Topline Data
- 2026-09-30: EVO756 — Evommune Inc. — Initial Data
- 2026-09-30: Halneuron - (HALT-CINP / HAL-CINP-203) — Dogwood Therapeutics Inc. — Topline Data
- 2026-09-30: ESK-001 - (LUMUS) — Alumis Inc. — Topline Data
- 2026-09-30: 4D-150 - (PRISM) — 4D Molecular Therapeutics Inc. — Conference Presentation
- 2026-09-30: Efgartigimod - (ALKIVIA) — argenx SE — Topline Data
- 2026-09-30: VYD2311 - (LIBERTY) — Invivyd Inc. — Topline Data
- 2026-09-30: VK2735 - (VANQUISH-2) — Viking Therapeutics Inc. — Interim Data
- 2026-09-30: VYD2311 - (DECLARATION) — Invivyd Inc. — Topline Data
- 2026-09-30: DT120 ODT (MM120) lysergide tartrate - (Panorama) — Definium Therapeutics Inc. — Topline Data
- 2026-09-30: TNX-103 (oral levosimendan) - (LEVEL) — Tenax Therapeutics Inc. — Topline Data
- 2026-09-30: Tarcocimab tedromer (KSI-501) - (DAYBREAK) — Kodiak Sciences Inc — Topline Data
- 2026-09-30: DT120 ODT (MM120) (lysergide D-tartrate, LSD) - (Voyage) — Definium Therapeutics Inc. — Topline Data
- 2026-09-30: Deucrictibant (PHVS416) - (CHAPTER-3) — Pharvaris N.V. — Topline Data
- 2026-09-30: Avexitide (Exendin 9-39) - (LUCIDITY) — Amylyx Pharmaceuticals Inc. — Initial Data
- 2026-09-30: UGN-103 - (UTOPIA) — UroGen Pharma Ltd. — Submission
- 2026-09-30: COMP360 psilocybin - (COMP006) — Tactile Systems Technology Inc. — Submission
- 2026-09-30: CNM-Au8 - (HEALEY ALS) — Clene Inc. — Submission
- 2026-09-30: Azetukalner (XEN1101) - (X-TOLE2) — Xenon Pharmaceuticals Inc. — Submission
- 2026-09-30: AMT-130 — uniQure N.V. — Submission
- 2026-09-30: Mim8 - (FRONTIER5) — Novo Nordisk A/S — Regulatory Decision
- 2026-09-30: Rusfertide - (REVIVE) — Protagonist Therapeutics Inc. — Regulatory Decision
- 2026-09-30: Enhertu (trastuzumab deruxtecan) - (DESTINY-Breast05) — AstraZeneca PLC — Regulatory Decision
- 2026-09-30: Brepocitinib - (VALOR) — Pfizer Inc. — Regulatory Decision
- 2026-09-30: Oveporexton (TAK-861-2001) — Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) — Regulatory Decision
FDA Events Calendar
September 2026
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Clinical Read
Regulatory
Meetings & Presentations