Catalyst tracker
Free, sourced FDA decision dates and clinical readouts for US-listed biopharma. Every row links to the filing or notice that announced it, so you can check the date yourself rather than taking our word for it.
| Company ▾ | Drug ▾ | Effect / indication | Next catalyst ▾ | Phase / type ▾ | Status ▾ | Source | Options |
|---|---|---|---|---|---|---|---|
| Ultragenyx Pharmaceutical RARE · Nasdaq | UX111 | Sanfilippo syndrome type A (MPS IIIA) | 19 Sep 2026 18d ago |
PDUFA date | Reported | Catalyst calendar ↗ | Yes |
| Mirum Pharmaceuticals MIRM · Nasdaq | Zilurgisertib | Fibrodysplasia ossificans progressiva (FOP) | 26 Sep 2026 11d ago |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| C4 Therapeutics CCCC · Nasdaq | Cemsidomide | Multiple myeloma — biomarker data at IMS Annual Meeting | Sep 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Celldex Therapeutics CLDX · Nasdaq | Barzolvolimab | Chronic spontaneous urticaria (anti-KIT) | Sep 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Kodiak Sciences KOD · Nasdaq | Zenkuda (tarcocimab) and KSI-501 | Wet age-related macular degeneration | Sep 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arcturus Therapeutics ARCT · Nasdaq | ARCT-810 | Ornithine transcarbamylase deficiency | Q3 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Invivyd IVVD · Nasdaq | VYD2311 | COVID-19 prevention (monoclonal antibody) | Q3 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Invivyd IVVD · Nasdaq | VYD2311 | COVID-19 safety versus mRNA vaccine | Q3 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Kyverna Therapeutics KYTX · Nasdaq | Miv-cel (mivotacel) | Stiff person syndrome | Q3 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| 60 Degrees Pharmaceuticals SXTP · Nasdaq | Tafenoquine | Babesiosis (interim analysis) | 06 Oct 2026 1d ago |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Merck & Co. MRK · NYSE | Ifinatamab deruxtecan (I-DXd) | Small cell lung cancer | 10 Oct 2026 in 3d |
PDUFA date | Reported | Catalyst calendar ↗ | Yes |
| Ionis Pharmaceuticals IONS · Nasdaq | Bepirovirsen | Chronic hepatitis B | 26 Oct 2026 in 19d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Inovio Pharmaceuticals INO · Nasdaq | INO-3107 | Recurrent respiratory papillomatosis (RRP) | 30 Oct 2026 in 23d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arvinas ARVN · Nasdaq | ARV-102 | Parkinson’s disease (LRRK2 degrader) — biomarker data | Oct 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CervoMed CRVO · Nasdaq | Neflamapimod | Non-fluent variant primary progressive aphasia (biomarker data) | Oct 2026 company guidance |
Phase 2A readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Compass Therapeutics CMPX · Nasdaq | Tovecimig | Biliary tract cancer (DLL4 x VEGF-A bispecific) | Oct 2026 company guidance |
Phase 2/3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| MacroGenics MGNX · Nasdaq | MGC026 | Advanced solid tumours (B7-H3 ADC) | Oct 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Rapport Therapeutics RAPP · Nasdaq | RAP-219 | Bipolar mania (AMPA receptor modulator) | Oct 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Verastem Oncology VSTM · Nasdaq | VS-7375 | KRAS G12D-mutant solid tumours | Oct 2026 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Xencor XNCR · Nasdaq | XmAb819 | Advanced clear cell renal cell carcinoma (ENPP3 x CD3) | Oct 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Cytokinetics CYTK · Nasdaq | Aficamten | Hypertrophic cardiomyopathy (MAPLE-HCM sNDA) | 14 Nov 2026 in 38d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Capricor Therapeutics CAPR · Nasdaq | Deramiocel | Duchenne muscular dystrophy cardiomyopathy | 22 Nov 2026 in 46d |
PDUFA date (extended) | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Savara Inc. SVRA · Nasdaq | Molgramostim | Autoimmune pulmonary alveolar proteinosis (aPAP) | 22 Nov 2026 in 46d |
PDUFA date | Reported | Catalyst calendar ↗ | Yes |
| BridgeBio Pharma BBIO · Nasdaq | BBP-418 | Limb-girdle muscular dystrophy type 2I/R9 | 27 Nov 2026 in 51d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| PolyPid Ltd. PYPD · Nasdaq | D-PLEX100 | Prevention of surgical site infection in abdominal colorectal surgery | 28 Nov 2026 in 52d |
PDUFA date | Verified | 6-K exhibit 99.1 ↗ | Yes |
| Cogent Biosciences COGT · Nasdaq | Bezuclastinib | Gastrointestinal stromal tumour (GIST) | 30 Nov 2026 in 54d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Zai Lab Ltd. ZLAB · Nasdaq | Povetacicept | IgA nephropathy | 30 Nov 2026 in 54d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Vanda Pharmaceuticals VNDA · Nasdaq | Quimilza (imsidolimab) | Generalised pustular psoriasis | 12 Dec 2026 in 66d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Corcept Therapeutics CORT · Nasdaq | Relacorilant | Cushing's syndrome | 17 Dec 2026 in 71d |
FDA decision expected | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Praxis Precision Medicines PRAX · Nasdaq | Relutrigine | SCN2A and SCN8A developmental epileptic encephalopathies | 27 Dec 2026 in 81d |
PDUFA date (extended) | Verified | 8-K press release ↗ | Yes |
| Cogent Biosciences COGT · Nasdaq | Bezuclastinib | Non-advanced systemic mastocytosis | 30 Dec 2026 in 84d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Kodiak Sciences KOD · Nasdaq | KSI-101 | Macular oedema secondary to inflammation (MESI) | Dec 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| 4D Molecular Therapeutics FDMT · Nasdaq | 4D-710 | Cystic fibrosis lung disease | Q4 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Allogene Therapeutics ALLO · Nasdaq | ALLO-329 | Autoimmune disease (allogeneic CD19/CD70 CAR-T) | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Alumis ALMS · Nasdaq | Envudeucitinib | Plaque psoriasis (TYK2 inhibitor) | Q4 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Annexon ANNX · Nasdaq | Tanruprubart | Guillain-Barré syndrome | Q4 2026 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Annexon ANNX · Nasdaq | Vonaprument | Geographic atrophy (Month 15 primary endpoint) | Q4 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Aprea Therapeutics APRE · Nasdaq | APR-1051 | Advanced solid tumours (WEE1 inhibitor) | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Arcturus Therapeutics ARCT · Nasdaq | ARCT-032 | Cystic fibrosis (inhaled mRNA) | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Attovia Therapeutics ATTO · Nasdaq | ATTO-1310 | Chronic pruritus and high-itch atopic dermatitis (IL-31) | Q4 2026 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Candel Therapeutics CADL · Nasdaq | Linoserpaturev (CAN-2409) | Recurrent high-grade glioma | Q4 2026 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Candel Therapeutics CADL · Nasdaq | Aglatimagene besadenovec (CAN-2409) | Localised prostate cancer | Q4 2026 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CG Oncology CGON · Nasdaq | Cretostimogene grenadenorepvec | High-risk BCG-unresponsive NMIBC | Q4 2026 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Compass Therapeutics CMPX · Nasdaq | CTX-8371 | TNBC, NSCLC and Hodgkin lymphoma post-checkpoint (PD-1 x PD-L1) | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Compass Therapeutics CMPX · Nasdaq | CTX-10726 | Solid tumours (PD-1 x VEGF-A bispecific) | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Enanta Pharmaceuticals ENTA · Nasdaq | EDP-978 | Chronic urticaria | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| EyePoint EYPT · Nasdaq | DURAVYU (vorolanib insert) | Wet age-related macular degeneration | Q4 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Fractyl Health GUTS · Nasdaq | Revita | Post-GLP-1 weight maintenance — 6-month randomised data | Q4 2026 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Jasper Therapeutics JSPR · Nasdaq | KP-104 | Rare renal indications (complement inhibitor) | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Kyverna Therapeutics KYTX · Nasdaq | Miv-cel (mivotacel) | Progressive multiple sclerosis | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Lexeo Therapeutics LXEO · Nasdaq | LX2020 | PKP2 arrhythmogenic cardiomyopathy (gene therapy) | Q4 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| MBX Biosciences MBX · Nasdaq | MBX 4291 | Obesity (long-acting GLP-1/GIP peptide prodrug) | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Neumora Therapeutics NMRA · Nasdaq | NMRA-511 | Alzheimer’s disease agitation (V1a antagonist) | Q4 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ocular Therapeutix OCUL · Nasdaq | AXPAXLI (OTX-TKI) | Wet age-related macular degeneration | Q4 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| PMV Pharmaceuticals PMVP · Nasdaq | Rezatapopt | TP53 Y220C-mutant solid tumours | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Rapport Therapeutics RAPP · Nasdaq | RAP-219 | Focal onset seizures — open-label safety | Q4 2026 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| SELLAS Life Sciences Group SLS · Nasdaq | SLS009 (tambiciclib) | Newly diagnosed first-line acute myeloid leukaemia | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| SpyGlass Pharma SGP · Nasdaq | BIM-DRS | Open-angle glaucoma and ocular hypertension | Q4 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Spyre Therapeutics SYRE · Nasdaq | SPY072 | Psoriatic arthritis | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Spyre Therapeutics SYRE · Nasdaq | SPY072 | Axial spondyloarthritis | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Structure Therapeutics GPCR · Nasdaq | Aleniglipron | Type 2 diabetes with obesity or overweight | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Tenaya Therapeutics TNYA · Nasdaq | TN-201 | MYBPC3-associated hypertrophic cardiomyopathy | Q4 2026 company guidance |
Phase 1B/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Tenaya Therapeutics TNYA · Nasdaq | TN-401 | PKP2-associated arrhythmogenic right ventricular cardiomyopathy | Q4 2026 company guidance |
Phase 1B/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Zura Bio ZURA · Nasdaq | Tibulizumab (ZB-106) | Hidradenitis suppurativa | Q4 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Absci ABSI · Nasdaq | ABS-201 | Androgenetic (pattern) hair loss | H2 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Acrivon Therapeutics ACRV · Nasdaq | ACR-368 | Serous endometrial cancer | H2 2026 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Annexon ANNX · Nasdaq | ANX1502 | Cold agglutinin disease | Late 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Apogee Therapeutics APGE · Nasdaq | APG279 (zumilokibart + APG990) | Atopic dermatitis | H2 2026 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Aptevo Therapeutics APVO · Nasdaq | Mipletamig + venetoclax/azacitidine | Frontline acute myeloid leukaemia | Late 2026 company guidance |
Phase 1B/2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Arcus Biosciences RCUS · Nasdaq | Casdatifan + zimberelimab | First-line clear cell renal cell carcinoma | H2 2026 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arcus Biosciences RCUS · Nasdaq | Casdatifan + cabozantinib | Second-line clear cell renal cell carcinoma | H2 2026 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| ArriVent BioPharma AVBP · Nasdaq | Firmonertinib | First-line EGFR exon 20 insertion NSCLC | H2 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arvinas ARVN · Nasdaq | ARV-806 | KRAS G12D-mutant solid tumours (degrader) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arvinas ARVN · Nasdaq | ARV-393 | Relapsed/refractory non-Hodgkin lymphoma (BCL6 degrader) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| C4 Therapeutics CCCC · Nasdaq | Cemsidomide + elranatamab | Multiple myeloma — dose escalation progress | H2 2026 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Caribou Biosciences CRBU · Nasdaq | CB-011 | Relapsed/refractory multiple myeloma (allogeneic BCMA CAR-T) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Celldex Therapeutics CLDX · Nasdaq | Barzolvolimab | Atopic dermatitis | Late 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CervoMed CRVO · Nasdaq | Neflamapimod | Recovery after stroke | H2 2026 company guidance |
Phase 2A readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Corvus Pharmaceuticals CRVS · Nasdaq | Soquelitinib | Atopic dermatitis (ITK inhibitor) | Late 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CytomX Therapeutics CTMX · Nasdaq | Varseta-M (CX-2051) | Metastatic colorectal cancer (EpCAM ADC) | Late 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Eikon Therapeutics EIKN · Nasdaq | EIK1001 | Non-squamous NSCLC (TLR7/8 agonist) | H2 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Eikon Therapeutics EIKN · Nasdaq | EIK1001 | Melanoma — first interim analysis | H2 2026 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Eikon Therapeutics EIKN · Nasdaq | EIK1003 | Advanced solid tumours (PARP1-selective) | H2 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Eikon Therapeutics EIKN · Nasdaq | EIK1005 | Advanced solid tumours (WRN helicase inhibitor) | H2 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| enGene Holdings ENGN · Nasdaq | Detalimogene voraplasmid | Non-muscle invasive bladder cancer | H2 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| enGene Holdings ENGN · Nasdaq | Detalimogene voraplasmid | Non-muscle invasive bladder cancer | H2 2026 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ensysce Biosciences ENSC · Nasdaq | CY-200 | Complex regional pain syndrome type 1 | H2 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Erasca ERAS · Nasdaq | ERAS-4001 | KRAS-mutant solid tumours (pan-KRAS inhibitor) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Faeth Therapeutics FTH · Nasdaq | PIK-201 (PIKTOR) | Endometrial cancer | Late 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Forte Biosciences FBRX · Nasdaq | FB102 | Celiac disease (anti-CD122) | H2 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Fractyl Health GUTS · Nasdaq | RJVA-001 | Type 2 diabetes (pancreatic gene therapy) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| IN8bio INAB · Nasdaq | INB-100 | Leukaemia (gamma-delta T cell therapy) | Late 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Kymera Therapeutics KYMR · Nasdaq | KT-621 | Atopic dermatitis (oral STAT6 degrader) | Late 2026 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| MacroGenics MGNX · Nasdaq | MGC028 | Advanced solid tumours (ADAM9 ADC) | Late 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Maze Therapeutics MAZE · Nasdaq | MZE829 | APOL1-mediated kidney disease | Late 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Monte Rosa Therapeutics GLUE · Nasdaq | MRT-8102 | Elevated cardiovascular disease risk (NEK7 degrader) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Monte Rosa Therapeutics GLUE · Nasdaq | MRT-2359 | Advanced castration-resistant prostate cancer | Late 2026 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Neumora Therapeutics NMRA · Nasdaq | NMRA-898 | Schizophrenia (M4 positive allosteric modulator) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Roivant Sciences ROIV · Nasdaq | Brepocitinib | Non-infectious uveitis | H2 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Roivant Sciences ROIV · Nasdaq | IMVT-1402 | Cutaneous lupus erythematosus | H2 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Roivant Sciences ROIV · Nasdaq | IMVT-1402 | Difficult-to-treat rheumatoid arthritis | H2 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Tvardi Therapeutics TVRD · Nasdaq | TTI-101 | Hepatocellular carcinoma (STAT3 inhibitor) | H2 2026 company guidance |
Phase 1B/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Xencor XNCR · Nasdaq | Plamotamab | Rheumatoid arthritis (CD20 x CD3) | H2 2026 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Xencor XNCR · Nasdaq | XmAb657 | B-cell autoimmune disease (CD19 x CD3) | H2 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Xencor XNCR · Nasdaq | XmAb942 | Ulcerative colitis (anti-TL1A) — blinded interim analysis | Late 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CG Oncology CGON · Nasdaq | Cretostimogene grenadenorepvec | Intermediate-risk non-muscle invasive bladder cancer | 2026 timing unconfirmed |
Phase 3 readout | Needs check | 8-K exhibit 99.1 ↗ | Yes |
| Sagimet Biosciences SGMT · Nasdaq | TVB-3567 | Acne (FASN inhibitor) | 2026 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| ImmunityBio IBRX · Nasdaq | ANKTIVA (nogapendekin alfa) plus BCG | BCG-unresponsive NMIBC with papillary disease | 06 Jan 2027 in 91d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Dyne Therapeutics DYN · Nasdaq | z-rostudirsen (DYNE-251) | Duchenne muscular dystrophy, exon 51 skipping | 21 Jan 2027 in 106d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Praxis Precision Medicines PRAX · Nasdaq | Ulixacaltamide | Essential tremor | 29 Jan 2027 in 114d |
PDUFA date | Verified | 8-K press release ↗ | Yes |
| Belite Bio BLTE · Nasdaq | Tinlarebant | Stargardt disease type 1 | 12 Feb 2027 in 128d |
PDUFA date | Verified | 6-K exhibit 99.1 ↗ | No |
| Arcutis Biotherapeutics ARQT · Nasdaq | ZORYVE (roflumilast) cream 0.05% | Atopic dermatitis in infants aged 3–24 months | 23 Feb 2027 in 139d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | No |
| Cullinan Therapeutics CGEM · Nasdaq | Zipalertinib | EGFR exon 20 insertion NSCLC, second line | 27 Feb 2027 in 143d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Apnimed APMD · Nasdaq | AD109 (Oxnimbi) | Obstructive sleep apnoea in adults | 28 Feb 2027 in 144d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | No |
| Intellia Therapeutics NTLA · Nasdaq | Lonvoguran ziclumeran (lonvo-z) | Hereditary angioedema (HAE) | 10 Mar 2027 in 154d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Aktis Oncology AKTS · Nasdaq | AKY-1189 | Urothelial and Nectin-4 expressing solid tumours (radiopharmaceutical) | Q1 2027 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Annovis Bio ANVS · Nasdaq | Buntanetap | Alzheimer’s disease — 6-month symptomatic data | Q1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Atea Pharmaceuticals AVIR · Nasdaq | Bemnifosbuvir + ruzasvir | Chronic hepatitis C | Q1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| aTyr Pharma ATYR · Nasdaq | Efzofitimod | Systemic sclerosis-associated interstitial lung disease | Q1 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Cartesian Therapeutics RNAC · Nasdaq | Descartes-08 | Myasthenia gravis (mRNA CAR-T) | Q1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CervoMed CRVO · Nasdaq | Neflamapimod | Non-fluent variant primary progressive aphasia | Q1 2027 company guidance |
Phase 2A readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Fractyl Health GUTS · Nasdaq | Revita | Post-GLP-1 weight maintenance — one-year data | Q1 2027 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Jasper Therapeutics JSPR · Nasdaq | Briquilimab | Chronic spontaneous urticaria / mast cell disease | Q1 2027 company guidance |
Regulatory milestone | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ocugen OCGN · Nasdaq | OCU400 | Retinitis pigmentosa (modifier gene therapy) | Q1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Olema Pharmaceuticals OLMA · Nasdaq | Palazestrant (OP-1250) | ER+/HER2- advanced breast cancer, 2nd/3rd line | Q1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| PMV Pharmaceuticals PMVP · Nasdaq | Rezatapopt | Platinum-resistant ovarian cancer, TP53 Y220C | Q1 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Septerna SEPN · Nasdaq | SEP-479 | Hypoparathyroidism (oral PTH1R agonist) | Q1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Stoke Therapeutics STOK · Nasdaq | Zorevunersen | Dravet syndrome | Q1 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Absci ABSI · Nasdaq | ABS-201 | Androgenetic (pattern) hair loss | Early 2027 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Harmony Biosciences Holdings HRMY · Nasdaq | Pitolisant GR | Narcolepsy | 01 Apr 2027 in 176d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Pharvaris N.V. PHVS · Nasdaq | Deucrictibant IR | Hereditary angioedema, on-demand treatment | 23 Apr 2027 in 198d |
PDUFA date | Verified | 6-K exhibit 99.2 ↗ | Yes |
| Immunome IMNM · Nasdaq | Varegacestat | Desmoid tumours | 28 Apr 2027 in 203d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Axsome Therapeutics AXSM · Nasdaq | AXS-12 (reboxetine) | Cataplexy in narcolepsy | 01 May 2027 in 206d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| BridgeBio Pharma BBIO · Nasdaq | Encaleret | Autosomal dominant hypocalcaemia type 1 (ADH1) | 08 May 2027 in 213d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Zenas BioPharma ZBIO · Nasdaq | Obexelimab | Immunoglobulin G4-related disease (IgG4-RD) | 27 May 2027 in 232d |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| 4D Molecular Therapeutics FDMT · Nasdaq | 4D-150 | Wet age-related macular degeneration | Q2 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Atea Pharmaceuticals AVIR · Nasdaq | Bemnifosbuvir + ruzasvir | Chronic hepatitis C | Q2 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Context Therapeutics CNTX · Nasdaq | CTIM-76 | Platinum-resistant ovarian cancer (Claudin 6 x CD3) | Q2 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Kodiak Sciences KOD · Nasdaq | KSI-101 | Macular oedema secondary to inflammation (MESI) | Q2 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ocugen OCGN · Nasdaq | OCU410ST | Stargardt disease | Q2 2027 company guidance |
Phase 2/3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ocugen OCGN · Nasdaq | OCU400 | Retinitis pigmentosa | Q2 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Allogene Therapeutics ALLO · Nasdaq | Cemacabtagene ansegedleucel | First-line large B-cell lymphoma consolidation | Mid 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Alumis ALMS · Nasdaq | Envudeucitinib | Plaque psoriasis | H1 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Aptevo Therapeutics APVO · Nasdaq | Mipletamig | Frontline acute myeloid leukaemia | H1 2027 company guidance |
Regulatory milestone | Verified | 8-K exhibit 99.1 ↗ | No |
| Arcus Biosciences RCUS · Nasdaq | Quemliclustat | First-line metastatic pancreatic ductal adenocarcinoma | H1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arvinas ARVN · Nasdaq | ARV-027 | Kennedy’s disease (polyQ-AR degrader) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arvinas ARVN · Nasdaq | ARV-393 | B- and T-cell lymphomas (BCL6 degrader) | Mid 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Arvinas ARVN · Nasdaq | ARV-393 + glofitamab | Diffuse large B-cell lymphoma | Mid 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| C4 Therapeutics CCCC · Nasdaq | Cemsidomide + elranatamab | Multiple myeloma | Mid 2027 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Cartesian Therapeutics RNAC · Nasdaq | Descartes-08 | Myositis | H1 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Cartesian Therapeutics RNAC · Nasdaq | Descartes-08 | Juvenile dermatomyositis (paediatric) | H1 2027 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Cartesian Therapeutics RNAC · Nasdaq | Descartes-08 | Myasthenia gravis | Mid 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Climb Bio CLYM · Nasdaq | CLYM116 (budoprutug) | IgA nephropathy / autoimmune (CD19 antibody) | H1 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CytomX Therapeutics CTMX · Nasdaq | Varseta-M + bevacizumab | Metastatic colorectal cancer | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| CytomX Therapeutics CTMX · Nasdaq | CX-801 + pembrolizumab | Advanced melanoma (masked interferon alpha-2b) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Erasca ERAS · Nasdaq | ERAS-0015 | RAS-mutant solid tumours (pan-RAS inhibitor) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Erasca ERAS · Nasdaq | ERAS-0015 + panitumumab | RAS-mutant colorectal cancer | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| EyePoint EYPT · Nasdaq | DURAVYU (vorolanib insert) | Wet age-related macular degeneration | H1 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Inhibikase Therapeutics IKT · Nasdaq | IKT-001 (imatinib prodrug) | Pulmonary arterial hypertension — interim safety (n=50) | H1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Kailera Therapeutics KLRA · Nasdaq | Ribupatide (KAI-9531) | Obesity (48-week high-dose trial) | Mid 2027 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Kardigan KARD · Nasdaq | Danicamtiv | Genetic dilated cardiomyopathy | H1 2027 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Kardigan KARD · Nasdaq | Ataciguat | Calcific aortic valve stenosis (interim 24-week analysis) | H1 2027 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Kardigan KARD · Nasdaq | Tonlamarsen | Acute severe hypertension | H1 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| LB Pharmaceuticals LBRX · Nasdaq | LB-102 | Schizophrenia | H1 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| MacroGenics MGNX · Nasdaq | Lorigerlimab | Clear cell gynaecologic cancer (PD-1 x CTLA-4) | H1 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ocugen OCGN · Nasdaq | OCU410ST | Stargardt disease | Mid 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Palvella Therapeutics PVLA · Nasdaq | QTORIN rapamycin | Microcystic lymphatic malformations | H1 2027 company guidance |
FDA decision expected | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Sana Biotechnology SANA · Nasdaq | SG293 | Non-Hodgkin lymphoma (in vivo CAR-T) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Scribe Therapeutics SCTX · Nasdaq | STX-1150 | Elevated LDL-C and ASCVD risk (in vivo CRISPR) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Seaport Therapeutics SPTX · Nasdaq | GlyphAllo | Major depressive disorder | H1 2027 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Stoke Therapeutics STOK · Nasdaq | STK-002 | Autosomal dominant optic atrophy | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Structure Therapeutics GPCR · Nasdaq | ACCG-2671 | Obesity | H1 2027 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Tempest Therapeutics TPST · Nasdaq | TPST-4003 | Myasthenia gravis / multiple sclerosis (CD7 in vivo CAR-T) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| TuHURA Biosciences HURA · Nasdaq | IFx-2.0 + pembrolizumab | Deep-seated Merkel cell carcinoma | H1 2027 company guidance |
Clinical readout | Verified | 8-K exhibit 99.1 ↗ | No |
| TuHURA Biosciences HURA · Nasdaq | TBS-2025 | NPM1-mutated relapsed/refractory AML (VISTA antibody) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Verastem Oncology VSTM · Nasdaq | Avutometinib + defactinib | Recurrent low-grade serous ovarian cancer | Mid 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Whitehawk Therapeutics WHWK · Nasdaq | HWK-007 | EGFR wild-type NSCLC, platinum-resistant ovarian and endometrial cancer | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Whitehawk Therapeutics WHWK · Nasdaq | HWK-016 | Advanced ovarian and endometrial cancers | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Xencor XNCR · Nasdaq | XmAb412 | Inflammatory disease (TL1A x IL23p19) | H1 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Zura Bio ZURA · Nasdaq | Tibulizumab (ZB-106) | Systemic sclerosis | H1 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Annexon ANNX · Nasdaq | Vonaprument | Geographic atrophy (Month 24) | Q3 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Stoke Therapeutics STOK · Nasdaq | Zorevunersen | Dravet syndrome | Q3 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Theriva Biologics TOVX · Nasdaq | VCN-01 | Metastatic pancreatic ductal adenocarcinoma (oncolytic adenovirus) | Q3 2027 company guidance |
Phase 2A readout | Verified | 8-K exhibit 99.1 ↗ | No |
| EyePoint EYPT · Nasdaq | DURAVYU (vorolanib insert) | Diabetic macular oedema — both pivotal trials | Q4 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| 4D Molecular Therapeutics FDMT · Nasdaq | 4D-150 | Wet age-related macular degeneration | H2 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Absci ABSI · Nasdaq | ABS-201 | Endometriosis | H2 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Altimmune ALT · Nasdaq | Pemvidutide | Alcohol-associated liver disease | H2 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Aura Biosciences AURA · Nasdaq | Belzupacap sarotalocan (bel-sar) | Early-stage choroidal melanoma | H2 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| C4 Therapeutics CCCC · Nasdaq | Cemsidomide + dexamethasone | Relapsed/refractory multiple myeloma | H2 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Context Therapeutics CNTX · Nasdaq | CT-202 | Urothelial, colorectal and triple-negative breast cancer (Nectin-4 x CD3) | H2 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Jade Biosciences JBIO · Nasdaq | JADE301 | Dermatomyositis | H2 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Lexeo Therapeutics LXEO · Nasdaq | LX2006 | Friedreich ataxia cardiomyopathy (gene therapy) | H2 2027 company guidance |
Phase 1/2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| MapLight Therapeutics MPLT · Nasdaq | ML-007C-MA | Alzheimer’s disease psychosis (hallucinations and delusions) | H2 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Minerva Neurosciences NERV · Nasdaq | Roluperidone | Negative symptoms of schizophrenia | H2 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Palvella Therapeutics PVLA · Nasdaq | QTORIN rapamycin | Clinically significant angiokeratomas | H2 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Trevi Therapeutics TRVI · Nasdaq | Haduvio (nalbuphine ER) | Chronic cough in idiopathic pulmonary fibrosis | H2 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Trevi Therapeutics TRVI · Nasdaq | Haduvio (nalbuphine ER) | Refractory chronic cough | H2 2027 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Xencor XNCR · Nasdaq | XmAb942 | Ulcerative colitis (12-week induction) | H2 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Xilio Therapeutics XLO · Nasdaq | XTX501 | Metastatic NSCLC (masked PD-1/IL-2 bispecific) | H2 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Aktis Oncology AKTS · Nasdaq | AKY-2519 | Metastatic castration-resistant prostate cancer (B7-H3 radiopharmaceutical) | 2027 company guidance |
Phase 1B readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Alumis ALMS · Nasdaq | Envudeucitinib | Plaque psoriasis | 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Celldex Therapeutics CLDX · Nasdaq | Barzolvolimab | Chronic spontaneous urticaria | 2027 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Definium Therapeutics DFTX · Nasdaq | DT120 ODT | Major depressive disorder | 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Enanta Pharmaceuticals ENTA · Nasdaq | Zelicapavir | RSV in high-risk adults | 2027 company guidance |
Phase 2/3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Faeth Therapeutics FTH · Nasdaq | PIK-101 (PIKTOR) | HR-positive breast cancer | 2027 company guidance |
Phase 1B/2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Jade Biosciences JBIO · Nasdaq | JADE101 | IgA nephropathy (APRIL antibody) | 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Jade Biosciences JBIO · Nasdaq | JADE201 | Rheumatoid arthritis | 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Kailera Therapeutics KLRA · Nasdaq | KAI-7535 | Obesity | 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Kailera Therapeutics KLRA · Nasdaq | KAI-4729 | Obesity | 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Maze Therapeutics MAZE · Nasdaq | MZE782 | Phenylketonuria (PKU) | 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Rapport Therapeutics RAPP · Nasdaq | RAP-219 long-acting injectable | Neurological disorders (LAI formulation) | 2027 company guidance |
Phase 1 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Roivant Sciences ROIV · Nasdaq | IMVT-1402 | Graves’ disease and myasthenia gravis | 2027 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Annovis Bio ANVS · Nasdaq | Buntanetap | Alzheimer’s disease — disease-modifying data | Q1 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| LB Pharmaceuticals LBRX · Nasdaq | LB-102 | Bipolar depression | Q1 2028 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ocular Therapeutix OCUL · Nasdaq | AXPAXLI (OTX-TKI) | Wet age-related macular degeneration | Q1 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Seaport Therapeutics SPTX · Nasdaq | GlyphAgo | Generalised anxiety disorder with sleep disturbance | Early 2028 company guidance |
Phase 2A readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Inhibikase Therapeutics IKT · Nasdaq | IKT-001 (imatinib prodrug) | Pulmonary arterial hypertension — PVR reduction (n=120) | Mid 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Lexeo Therapeutics LXEO · Nasdaq | LX2006 | Friedreich ataxia cardiomyopathy | H1 2028 company guidance |
Regulatory submission | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Trevi Therapeutics TRVI · Nasdaq | Haduvio (nalbuphine ER) | Chronic cough in IPF — 52-week fixed dosing | H1 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| X4 Pharmaceuticals XFOR · Nasdaq | Mavorixafor | Chronic neutropenia | H1 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Minerva Neurosciences NERV · Nasdaq | Roluperidone | Negative symptoms of schizophrenia | H2 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Seaport Therapeutics SPTX · Nasdaq | GlyphAgo | Generalised anxiety disorder | Late 2028 company guidance |
Phase 2B readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Skye Bioscience SKYE · Nasdaq | RXC008 | Fibrostenotic Crohn’s disease (GI-restricted pan-ROCK inhibitor) | H2 2028 timing unconfirmed |
Phase 2 readout | Needs check | 8-K exhibit 99.1 ↗ | No |
| Structure Therapeutics GPCR · Nasdaq | Aleniglipron | Obesity and overweight | H2 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Kailera Therapeutics KLRA · Nasdaq | Ribupatide (KAI-9531) | Obesity (global Phase 3) | 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | No |
| Roivant Sciences ROIV · Nasdaq | Brepocitinib | Cutaneous sarcoidosis | 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Roivant Sciences ROIV · Nasdaq | IMVT-1402 | CIDP and Sjögren’s disease | 2028 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
What actually happened at past decision dates and readouts, each linked to the filing or notice that reported it.
| Company ▾ | Drug ▾ | Effect / indication | Next catalyst ▾ | Phase / type ▾ | Status ▾ | Source | Options |
|---|---|---|---|---|---|---|---|
| Seaport Therapeutics SPTX · Nasdaq | GlyphAllo | Healthy volunteers (neuropsychiatric safety) | H2 2026 secondary source |
Phase 1 readout | Reported | Press release ↗ | No |
| Roivant Sciences ROIV · Nasdaq | Mosliciguat | Pulmonary hypertension with interstitial lung disease | H2 2026 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Palvella Therapeutics PVLA · Nasdaq | QTORIN rapamycin | Microcystic lymphatic malformations | H2 2026 secondary source |
Regulatory submission | Reported | Press release ↗ | Yes |
| Insmed INSM · Nasdaq | Brensocatib (BRINSUPRI) | Non-cystic fibrosis bronchiectasis (Japan) | H2 2026 secondary source |
Regulatory milestone | Reported | Press release ↗ | Yes |
| Ocugen OCGN · Nasdaq | OCU410ST | Stargardt disease (modifier gene therapy) | Q3 2026 company guidance |
Phase 2/3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Spyre Therapeutics SYRE · Nasdaq | SPY003 | Ulcerative colitis | Sep 2026 company guidance |
Phase 2 readout | Verified | 8-K ↗ | Yes |
| Spyre Therapeutics SYRE · Nasdaq | SPY072 | Rheumatoid arthritis | Sep 2026 company guidance |
Phase 2 readout | Verified | 8-K ↗ | Yes |
| Definium Therapeutics DFTX · Nasdaq | DT120 ODT | Generalised anxiety disorder | Sep 2026 company guidance |
Phase 3 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Ionis Pharmaceuticals IONS · Nasdaq | Zilganersen | Alexander disease | 22 Sep 2026 15d ago |
PDUFA date | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Nuvalent, Inc. NUVL · Nasdaq | Zidesamtinib | ROS1-positive non-small cell lung cancer (TKI pre-treated) | 18 Sep 2026 19d ago |
PDUFA date | Verified | FDA approval notice ↗ | Yes |
| Jazz Pharmaceuticals JAZZ · Nasdaq | Zanidatamab (Ziihera) | HER2-positive first-line gastroesophageal adenocarcinoma | 25 Aug 2026 43d ago |
PDUFA date | Verified | 8-K ↗ | Yes |
| Outlook Therapeutics OTLK · Nasdaq | ONS-5010 / LYTENAVA (bevacizumab-vikg) | Wet age-related macular degeneration | 29 Jul 2026 70d ago |
PDUFA date | Verified | 8-K ↗ | Yes |
| Vera Therapeutics VERA · Nasdaq | Atacicept | IgA nephropathy | 07 Jul 2026 92d ago |
PDUFA date | Verified | 8-K ↗ | Yes |
| Spero Therapeutics SPRO · Nasdaq | Utebzi (tebipenem pivoxil) | Complicated urinary tract infections including pyelonephritis | 18 Jun 2026 111d ago |
PDUFA date | Verified | 8-K ↗ | Yes |
Plain-English explainers for every kind of catalyst in the table, each built on the primary rules and real rows from the tracker. All 11 guides →
The PDUFA target action date is the FDA's own deadline for deciding on a drug application. Here is where it comes from, how it moves, and why you only hear about it from the company.
Who sits on an FDA advisory committee, how the day runs, what the vote means and doesn't mean, and where to find the documents beforehand.
A Complete Response Letter is the FDA's "not yet" on a drug application. What it contains, the company's options, how resubmission clocks work, and how to read the announcement.
Endpoints, p-values, effect sizes, safety tables and the phrase "met its primary endpoint": a practical guide to reading the press release a company puts out when pivotal trial results land.
What each phase of clinical development is for, roughly how big the trials are, what the in-between labels like 1b, 2a and 2/3 mean, and what a readout at each stage can and can't tell you.
Why some products are filed as a New Drug Application and others as a Biologics License Application, who reviews each, what supplements and rolling submissions are, and why the difference matters after approval.
Each row is one future event for one drug: either a regulatory step, such as an FDA decision, or a clinical readout, where a company reports trial results. The Next catalyst column shows the timing at the precision the company gave it. An exact date, usually a PDUFA target action date, gets a countdown. A window such as “H1 2027” is labelled as company guidance, because that is all anyone outside the company knows; here is why windows are vague and how they narrow.
Phase / type sorts by stage of development, from Phase 1 through to FDA decisions. Click a type label for a plain-English explainer of that kind of event. Status tells you how far to trust the row: Verified means a person read the linked filing, Reported means it came from a secondary source and is waiting for that check, and Needs check means something in the source is ambiguous and the row's note says what. Click any row to see the note and the exact filing date.
The Source link goes straight to the document that announced the date, usually an 8-K or 6-K filed with the SEC. If you would rather check a date yourself than take our word for it, this walkthrough shows how to find and read the filing. Options shows whether the stock has listed options, from the OCC's directory of listed products. The full method is on the methodology page.