August 2026 Catalyst Events
- 2026-08-02: RP1 (vusolimogene oderparepvec) and OPDIVO (nivolumab) - (IGNYTE-3) — Replimune Group Inc. — Regulatory Decision
- 2026-08-03: obrixtamig with zocilurtatug pelitecan (zoci, formerly ZL-1310) — Zai Lab Limited — Phase 1/2
- 2026-08-03: Piclidenoson — Can-Fite Biopharma Ltd American Depositary Shares each representing two (2) — Submission
- 2026-08-03: Ibezapolstat — Acurx Pharmaceuticals Inc. — Submission
- 2026-08-03: Ebribafusp (AKB-097 (ADX-097)) — Akebia Therapeutics Inc. — Initial Data
- 2026-08-03: EB103 (CD19) - (STARLIGHT-1) — Estrella Immunopharma Inc. — Phase 1/2
- 2026-08-03: Pemvidutide - (PERFORMA) — Altimmune Inc. — Topline Data
- 2026-08-03: Ampligen (rintatolimod) with Imfinzi (durvalumab) - (DURIPANC) — AstraZeneca PLC — Topline Data
- 2026-08-03: RP-A501 — Rocket Pharmaceuticals Inc. — Initial Data
- 2026-08-03: Olomorasib - (LOXO-RAS-20001) — Eli Lilly and Company — Phase 1/2
- 2026-08-04: mRNA-1469 — Moderna Inc. — Phase 1
- 2026-08-04: Sigvotatug vedotin (PF-08046047) - (SigVie-002) — Pfizer Inc. — Phase 3
- 2026-08-04: CRB-913 - (CANYON-1) — Corbus Pharmaceuticals Holdings Inc. — Topline Data
- 2026-08-04: Bexobrutideg - (DAYBreak CLL-306) — Nurix Therapeutics Inc. — Submission
- 2026-08-05: Rusfertide - (REVIVE) — Protagonist Therapeutics Inc. — Regulatory Decision
- 2026-08-05: ORZEYFUL (Oveporexton (TAK-861-2001)) — Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) — Approved
- 2026-08-05: Bria-Pros+ — BriaCell Therapeutics Corp. — Conference Presentation
- 2026-08-05: CT-95 (mesothelin) — Context Therapeutics Inc. — Topline Data
- 2026-08-05: EB-003 (EVM301 series) — Enveric Biosciences Inc. — Submission
- 2026-08-05: LX2020 - (HEROIC-PKP2) — Lexeo Therapeutics, Inc. — Interim Data
- 2026-08-05: ACR-2316 — Acrivon Therapeutics Inc. — Phase 1/2
- 2026-08-05: mRNA-1010 - (P304) — Moderna Inc. — Regulatory Decision
- 2026-08-05: mRNA-1010 - (P304) — Moderna Inc. — Regulatory Decision
- 2026-08-06: BMN 401 (INZ-701) - (ENERGY-2) — BioMarin Pharmaceutical Inc. — Regulatory Decision
- 2026-08-06: BMN 401 (INZ-701) - (ENERGY-1) — BioMarin Pharmaceutical Inc. — Regulatory Decision
- 2026-08-06: TUDRIQEV (vusolimogene oderparepvec-wtpg) and OPDIVO (nivolumab) - (IGNYTE-3) — Replimune Group Inc. — Approved
- 2026-08-06: OCS-01 - (DIAMOND-1) — Oculis Holding AG — Submission
- 2026-08-06: LN-145 - (IOV-LUN-202) — Iovance Biotherapeutics Inc. — Submission
- 2026-08-06: Bezisterim (NE3107) - (SUNRISE-PD) — BioVie Inc. — Phase 2
- 2026-08-06: Tanruprubart (ANX005) - (FORWARD) — Annexon Inc. — Submission
- 2026-08-06: Fasedienol (PH94B) - (PALISADE-2) — Vistagen Therapeutics Inc. — Topline Data
- 2026-08-06: KSI-101 - (PEAK) — Kodiak Sciences Inc — Topline Data
- 2026-08-06: KSI-101 - (PINNACLE) — Kodiak Sciences Inc — Topline Data
- 2026-08-06: TransCon hGH/TransCon CNP combination - (COACH) — Ascendis Pharma A/S — Conference Presentation
- 2026-08-06: SKNY-1 — MIRA Pharmaceuticals Inc. — Preclinical
- 2026-08-06: agenT-797 - (C-1300-02) — MiNK Therapeutics Inc. — End of Phase Meeting
- 2026-08-06: mRNA-1010 - (P304) — Moderna Inc. — Approved
- 2026-08-06: CMND-100 — Clearmind Medicine Inc. — Phase 1/2
- 2026-08-06: ENFLONSIA (clesrovimab) - (MK-1654-007/SMART) — Merck & Company Inc. — Regulatory Decision
- 2026-08-06: zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel -(VIRAGE2) — Theriva Biologics, Inc. — End of Phase Meeting
- 2026-08-06: PGN-EDODM2 - (FREEDOM-DM1/2) — PepGen Inc. — End of Phase Meeting
- 2026-08-07: Apitegromab - (SAPPHIRE) — Scholar Rock Holding Corporation — Regulatory Decision
- 2026-08-07: NBIP-'1968 — Neurocrine Biosciences Inc. — Initial Data
- 2026-08-07: modzatinib (ATI-2138) — Aclaris Therapeutics Inc. — Phase 2b
- 2026-08-07: KETAFREE — NRX Pharmaceuticals Inc. — Regulatory Decision
- 2026-08-08: Serabelisib and sapanisertib (FTH-PIK-201) - (PIKTOR) — Faeth Therapeutics Inc. — Conference Presentation
- 2026-08-09: BMN 401 (INZ-701) — BioMarin Pharmaceutical Inc. — Regulatory Decision
- 2026-08-09: BMN 333 - (ASPEN) — BioMarin Pharmaceutical Inc. — Regulatory Decision
- 2026-08-10: SION-451 + SION-109 — Sionna Therapeutics Inc. — Topline Data
- 2026-08-10: Prolastin-C (Alpha-1 MP) - (SPARTA) — Grifols S.A. — Topline Data
- 2026-08-10: Nanobody sonelokimab - (IZAR-1) — MoonLake Immunotherapeutics — Regulatory Decision
- 2026-08-10: Divesiran (SLN124) - (SANRECO) — Silence Therapeutics Plc — Topline Data
- 2026-08-10: TNX-103 (oral levosimendan) - (LEVEL) — Tenax Therapeutics Inc. — Conference Presentation
- 2026-08-10: SION-719 - (PreciSION CF) — Sionna Therapeutics Inc. — Topline Data
- 2026-08-10: Ziftomenib (in combination with SoC cytarabine/daunorubicin (7+3) and venetoclax/azacitidine (ven/aza))- (KOMET-007) — Kura Oncology Inc. — Preclinical
- 2026-08-10: ABCL635 — AbCellera Biologics Inc. — Topline Data
- 2026-08-10: ART27.13 - (Investigator-Initiated Study) - (DREAM) — Artelo Biosciences Inc. — Interim Data
- 2026-08-10: SION-451 + Galicaftor (SION-2222) — Sionna Therapeutics Inc. — Topline Data
- 2026-08-10: ABCL635 — AbCellera Biologics Inc. — Topline Data
- 2026-08-10: KETAFREE — NRX Pharmaceuticals Inc. — Conference Presentation
- 2026-08-10: DT120 ODT (MM120) (lysergide D-tartrate, LSD) - (Voyage) — Definium Therapeutics Inc. — Topline Data
- 2026-08-11: Tinlarebant (LBS-008) - (DRAGON) — Belite Bio Inc — Regulatory Decision
- 2026-08-11: OV888/GV101 — Ovid Therapeutics Inc. — Phase 2
- 2026-08-11: ACI-7104.056 - (VacSYn) — AC Immune SA — Interim Data
- 2026-08-11: RenovoGem - (TIGeR-PaC) — RenovoRx Inc. — Topline Data
- 2026-08-11: PDS0101 in combination with KEYTRUDA - (VERSATILE-003) — PDS Biotechnology Corporation — Phase 3
- 2026-08-12: Zipalertinib (CLN-081/TAS6417) - (REZILIENT3) — Cullinan Therapeutics Inc. — Submission
- 2026-08-12: NEO100-01 — NeOnc Technologies Holdings Inc. — End of Phase Meeting
- 2026-08-12: DT120 ODT (MM120) (lysergide D-tartrate, LSD) - (Voyage) — Definium Therapeutics Inc. — Topline Data
- 2026-08-12: NEO100-01 — NeOnc Technologies Holdings Inc. — Topline Data
- 2026-08-13: ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) - (EXCALIBER-RRMM) — Bristol-Myers Squibb Company — Regulatory Decision
- 2026-08-13: ST-01156 — BeyondSpring Inc. — IND-Enabling
- 2026-08-13: ASC40 (denifanstat) — Sagimet Biosciences Inc. — Phase 3
- 2026-08-13: EP-104GI - (RESOLVE) — Eupraxia Pharmaceuticals Inc. — Interim Data
- 2026-08-13: REYOBIQ (rhenium Re186 obisbemeda) - (ReSPECT-LM) — Cerenome Inc Com Par $0.0001 (New) Jan 2026 — Conference Presentation
- 2026-08-13: Florquinitau (MK-6240) — Lantheus Holdings Inc. — Regulatory Decision
- 2026-08-14: TAUKLARIFY (Florquinitau F 18 injection (MK-6240)) — Lantheus Holdings Inc. — Approved
- 2026-08-14: FT819 - (RECLAIM-LN) — Fate Therapeutics Inc. — Phase 2
- 2026-08-17: KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYNOTE-B15/EV-304) — Astellas Pharma Inc. ADR — Regulatory Decision
- 2026-08-17: iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone - (EXCALIBER RRMM) — Bristol-Myers Squibb Company — Regulatory Decision
- 2026-08-19: TTI-109 — Tvardi Therapeutics Inc. — Conference Presentation
- 2026-08-22: Deramiocel (CAP-1002) - (HOPE-3) — Capricor Therapeutics Inc. — Regulatory Decision
- 2026-08-22: Deramiocel (CAP-1002) - (HOPE-2) — Capricor Therapeutics Inc. — Regulatory Decision
- 2026-08-23: DTX401 AAV gene therapy (pariglasgene brecaparvovec) — Ultragenyx Pharmaceutical Inc. — Regulatory Decision
- 2026-08-24: LEQEMBI IQLIK (lecanemab-irmb)(at-home injection) — Biogen Inc. — Regulatory Decision
- 2026-08-25: Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01) — BeOne Medicines Ltd. — Regulatory Decision
- 2026-08-25: Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01) — BeOne Medicines Ltd. — Regulatory Decision
- 2026-08-27: Bictegravir and Lenacapavir - (ARTISTRY-2) — Gilead Sciences Inc. — Regulatory Decision
- 2026-08-29: TNX-103 (oral levosimendan) - (LEVEL) — Tenax Therapeutics Inc. — Topline Data
- 2026-08-30: Plozasiran (ARO-APOC3-3004) - (SHASTA-4) — Arrowhead Pharmaceuticals Inc. — Full Results
- 2026-08-30: Plozasiran (ARO-APOC3-3003) - (SHASTA-3) — Arrowhead Pharmaceuticals Inc. — Conference Presentation
- 2026-08-31: STRO-004 - (STRIVE-01) — Sutro Biopharma Inc. — Initial Data
- 2026-08-31: Efzofitimod - (EFZO-FIT) — aTyr Pharma Inc. — End of Phase Meeting
- 2026-08-31: Aficamten - (ACACIA-HCM) — Cytokinetics Incorporated — Conference Presentation
- 2026-08-31: ABCL635 — AbCellera Biologics Inc. — Topline Data
- 2026-08-31: DURAVYU (EYP-1901) - (LUGANO) — EyePoint Inc. — Topline Data
- 2026-08-31: Rusfertide - (REVIVE) — Protagonist Therapeutics Inc. — Regulatory Decision
- 2026-08-31: Selinexor (XPORT-MF-034) - (SENTRY) — Karyopharm Therapeutics Inc. — Submission
- 2026-08-31: Wainua (eplontersen) - (CARDIO-TTRansform) — Ionis Pharmaceuticals Inc. — Conference Presentation
- 2026-08-31: ION775 — Ionis Pharmaceuticals Inc. — Conference Presentation
- 2026-08-31: Pelareorep in combination with bevacizumab (Avastin) and leucovorin, fluorouracil, irinotecan (FOLFIRI) - (REO 033) — Oncolytics Biotech Inc. — End of Phase Meeting
- 2026-08-31: Wainua (eplontersen) - (CARDIO-TTRansform) — AstraZeneca PLC — Conference Presentation
- 2026-08-31: Prulacabtagene leucel (prula-cel, formerly ADI-001) — Adicet Bio Inc. — Interim Data
- 2026-08-31: ML-007C-MA - (ZEPHYR) — MapLight Therapeutics Inc. — Topline Data
- 2026-08-31: Emiltatug Ledadotin (XMT-1660) - (Emi-Le) — Day One Biopharmaceuticals Inc. — Initial Data
- 2026-08-31: CLR 125 — Cellectar Biosciences Inc. — Interim Data
- 2026-08-31: CRB-913 - (CANYON-1) — Corbus Pharmaceuticals Holdings Inc. — Topline Data
- 2026-08-31: NEO100 — NeOnc Technologies Holdings Inc. — Initial Data
- 2026-08-31: NGN-401 - (Embolden) — Neurogene Inc. — Interim Data
- 2026-08-31: RM-718 — Rhythm Pharmaceuticals Inc. — Interim Data
- 2026-08-31: Resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) - (RESET-MG) — Cabaletta Bio Inc. — Interim Data
- 2026-08-31: ENTR-601-45 - (ELEVATE-45-201) — Entrada Therapeutics Inc. — Initial Data
- 2026-08-31: Belzupacap sarotalocan (AU-011) — Aura Biosciences Inc. — Initial Data
- 2026-08-31: SION-719 - (PreciSION CF) — Sionna Therapeutics Inc. — Interim Data
- 2026-08-31: NEO100-01 — NeOnc Technologies Holdings Inc. — Topline Data
- 2026-08-31: Bempikibart - (SIGNAL-AA) — Q32 Bio Inc. — Topline Data
- 2026-08-31: Lorigerlimab - (LINNET) — MacroGenics Inc. — Interim Data
- 2026-08-31: Obexelimab - (SunStone) — Zenas BioPharma Inc. — Topline Data
- 2026-08-31: TYRA-300 - (SURF302) — Tyra Biosciences Inc. — Initial Data
- 2026-08-31: Casdozokitug/toripalimab/bevacizumab — Coherus Oncology Inc. — Initial Data
- 2026-08-31: Divesiran (SLN124) - (SANRECO) — Silence Therapeutics Plc — Topline Data
- 2026-08-31: Remlifanserin (ACP-204) - (RADIANT) — ACADIA Pharmaceuticals Inc. — Topline Data
- 2026-08-31: DURAVYU (EYP-1901) - (LUGANO) — EyePoint Inc. — Topline Data
- 2026-08-31: S4V2 Shigella Vaccine - (CHIM study) — Valneva SE — Submission
- 2026-08-31: Laromestrocel (lomecel-B) - (ELPIS II) — Longeveron Inc. — Topline Data
- 2026-08-31: Nanobody (sonelokimab) - (VELA-TEEN) — MoonLake Immunotherapeutics — Interim Data
- 2026-08-31: SVR12 in combination of bemnifosbuvir and ruzasvir - (C-BEYOND) — Atea Pharmaceuticals Inc. — Topline Data
- 2026-08-31: Furmonertinib - (FURVENT) — ArriVent BioPharma Inc. — Topline Data
- 2026-08-31: Nanobody sonelokimab - (IZAR-1) — MoonLake Immunotherapeutics — Initial Data
- 2026-08-31: Zanzalintinib - (STELLAR-304) — Exelixis Inc. — Topline Data
- 2026-08-31: EscharEx - (VALUE) — 3M Company — Interim Data
- 2026-08-31: ALXN1840 (WTX101) - (FoCus) — Monopar Therapeutics Inc. — Submission
- 2026-08-31: Garetosmab - (OPTIMA) — Regeneron Pharmaceuticals Inc. — Regulatory Decision
- 2026-08-31: MICVO (maMICVO) — Pyxis Oncology Inc. — End of Phase Meeting
- 2026-08-31: DURAVYU (EYP-1901) - (LUCIA) — EyePoint Inc. — Topline Data
- 2026-08-31: MGC026 — MacroGenics Inc. — Initial Data
- 2026-08-31: NMRA-898 — Neumora Therapeutics Inc. — End of Phase Meeting
- 2026-08-31: RAD202 (177Lu-RAD202) - (HEAT) — Radiopharm Theranostics Limited — Interim Data
- 2026-08-31: 177Lu-RAD204 — Radiopharm Theranostics Limited — Interim Data
- 2026-08-31: CLYM116 — Climb Bio Inc. — Initial Data
- 2026-08-31: NMRA-861 — Neumora Therapeutics Inc. — End of Phase Meeting
- 2026-08-31: SION-451 + SION-109 — Sionna Therapeutics Inc. — Topline Data
- 2026-08-31: SION-451 + Galicaftor (SION-2222) — Sionna Therapeutics Inc. — Topline Data
- 2026-08-31: STRO-004 — Sutro Biopharma Inc. — Initial Data
- 2026-08-31: Empasiprubart - (VARVARA) — argenx SE — Topline Data
- 2026-08-31: CT-95 (mesothelin) — Context Therapeutics Inc. — Initial Data
- 2026-08-31: micvotabart pelidotin (PYX-201-101) - (MICVO) — Pyxis Oncology Inc. — Interim Data
FDA Events Calendar
August 2026
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Meetings & Presentations