FDA Calendar Upcoming clinical readouts, trial starts, and trial-progress milestones for U.S.-listed biotech, with official source links.
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10 of 1,611 scheduled catalysts · 9 of 429 companies with matching events
Evidence: A regulator/SEC/trial registry · B official company source · Market data is separate context.
FiltersClinical data · Phase 2 − Scheduled catalysts Scroll the table horizontally to view all columns →
Next Catalyst Company Drug Price · 30D Current stage
Pharming Group N.V. PHAR Drug Joenja® (leniolisib) small molecule
Indication Primary immunodeficiencies with immune dysregulation leniolisib Phase 2 · 13 subjects with genetically defined PIDs · dose escalation
Target PI3Kδ
Clinical data Phase 2 data · Additional Oct 14-17, 2026 ESID 2026 leniolisib Phase 2 · Additional data will be presented
A Official sourceAll sources (2) Current stage Pre IND P1 P2 P3 Filing Approved
Achieve Life Sciences, Inc. ACHV Drug Cytisinicline
Indication E-cigarette/vaping cessation / Cigarette smoking cessation ORCA-OL · adults who previously participated in the ORCA-2, ORCA-3 or ORCA-V1 trials and were actively smoking cigarettes and/or vaping daily
Target α4β2 nicotinic acetylcholine receptor / 5-HT3 receptor
Clinical data Phase 2 data Oct 20, 2026 CHEST 2026 Study details ORCA-OL · new data evaluating the efficacy of 52 weeks of cytisinicline treatment for cigarette smoking and e-cigarette cessation will be presented
B Official sourceAll sources (2) Current stage Pre IND P1 P2 P3 Filing Approved
EIKON THERAPEUTICS, INC. EIKN Drug EIK1001
Indication Stage 4 non-small cell lung cancer TeLuRide-005 · Patients with NSCLC NCT06246110 Target TLR7 / TLR8
Clinical data Phase 2 data Oct 26, 2026 ESMO Congress 2026 TeLuRide-005 · will present comprehensive updated data from TeLuRide-005
B Official sourceAll sources (7) Current stage Pre IND P1 P2 P3 Filing Approved
IOVANCE BIOTHERAPEUTICS, INC. IOVA Drug Lifileucel autologous T cell therapy
Indication Undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma SARATOGA · first six evaluable patients · registrational
Target —
Clinical data Phase 2 data Oct 23-27, 2026 European Society for Medical Oncology (ESMO) SARATOGA · Results will be highlighted
A Official sourceCurrent stage Pre IND P1 P2 P3 Filing Approved
MOLECULAR PARTNERS AG MOLN Drug MP0317 multispecific protein therapeutic (DARPin)
Indication Advanced biliary tract cancer (cholangiocarcinoma) TACTIC · frontline setting NCT07036380 Target CD40 / FAP
Clinical data Conference presentation Oct 23-27, 2026 France · European Society for Medical Oncology (ESMO) Congress 2026 TACTIC · A trial-in-progress poster on the MP0317 Phase 2 study has been accepted for presentation
B Official sourceAll sources (2) Current stage Pre IND P1 P2 P3 Filing Approved
Inventiva S.A. IVA Drug lanifibranor small molecule
Indication MASH lanifibranor Phase 2b
Target PPARα / PPARδ / PPARγ
Clinical data Conference presentation Nov 7, 2026 AASLD The Liver Meeting ® 2026 Study details lanifibranor Phase 2b · Lanifibranor Improved Liver Sinusoidal Endothelial Cell Dysfunction and Vascular Alterations Across All Stages From MASH To Cirrhosis
A Official sourceAll sources (2) Current stage Pre IND P1 P2 P3 Filing Approved
Vir Biotechnology, Inc. VIR Drug Elebsiran and tobevibart
Indication Chronic hepatitis delta SOLSTICE · elebsiran + tobevibart · participants with chronic hepatitis delta infection
Target HBV RNA transcripts / HBV RNA
Clinical data Phase 2 data Nov 8, 2026 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026 SOLSTICE · Patterns of HDV RNA responses through Week 96
B Official sourceCurrent stage Pre IND P1 P2 P3 Filing Approved
Vir Biotechnology, Inc. VIR Drug Elebsiran and tobevibart
Indication Chronic hepatitis delta SOLSTICE · translational sub-study
Target HBV RNA transcripts / HBV RNA
Clinical data Phase 2 data Nov 8, 2026 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026 Study details SOLSTICE · Intrahepatic NK cell remodelling with elebsiran and tobevibart in chronic hepatitis D - A translational sub-study of the SOLSTICE trial
B Official sourceCurrent stage Pre IND P1 P2 P3 Filing Approved
FATE THERAPEUTICS INC FATE Drug FT819 CAR T-cell therapy
Indication Refractory moderate-to-severe systemic lupus erythematosus with lupus nephritis
Target CD19
Clinical data Phase 2 data Nov 9, 2026 ACR Convergence 2026 Efficacy Reveals Biomarker Candidates for Fatigue in SLE
B Official sourceCurrent stage Pre IND P1 P2 P3 Filing Approved
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