FreeBioList

Catalyst tracker

Upcoming FDA decisions & trial readouts

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.

Tracking — 227 catalysts Verified against filings — 222 Data checked — 14 Sep 2026
227Upcoming catalysts
3Exact dates within 30 days
180Clinical readouts tracked
10 Oct 2026Next dated decision — MRK
Click a row for the source · sort by any column — Phase orders 1 → 2 → 3 → 4 → PDUFA

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

Decided — the outcomes archive

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

Guides: what these events mean

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 →

How to read this tracker

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.