● Live Biotech Catalyst Calendar — Updated Regularly

Biotech Catalyst Calendar 2026

PDUFA dates, FDA AdCom meetings, Phase 3 trial readouts, and conference schedules. Curated by Dan Sfera — 20+ years in clinical trials, 10K+ biotech subscribers.

💊 PDUFA 17

🏛️ AdCom 2

🔬 Trial Readout 8

📋 Conference 6

📊 Earnings 6

39

Upcoming Catalysts

17

PDUFA Dates

18

Priority Review

92%

NDA/BLA Base PoA

Upcoming Catalysts

Sorted by date · All dates are target / expected dates

This Week: 2

This Month: 5

Upcoming: 32

KRESLADI (marnetegragene autotemcel (R...)

$RCKT Rocket Pharma · BLA

Leukocyte adhesion deficiency-I (LAD-I)

Priority Review BT Therapy Orphan

📋 Conference

ACC Scientific Sessions 2026

American College of Cardiology

Cardiology — Chicago, IL

Orca Bio · BLA

AML, ALL, MDS — allogeneic cell therapy for hematologic malignancies

Priority Review BT Therapy

$LLY Eli Lilly · NDA

Obesity / overweight (oral GLP-1 receptor agonist — once-daily pill)

Priority Review Fast Track BT Therapy

Filspari (sparsentan)

$TVTX Travere Therapeutics · sNDA

Focal segmental glomerulosclerosis (FSGS)

Priority Review BT Therapy Orphan

Rytelo (imetelstat)

$GERN Geron Corporation · sBLA

Myelodysplastic syndromes (MDS) — low to intermediate risk

Priority Review Fast Track Orphan

Lazcluze + Rybrevant (lazertinib + amivantamab-vmj...)

$JNJ Johnson & Johnson · sNDA

EGFR-mutated NSCLC — first-line treatment

Priority Review BT Therapy

📋 Conference

AACR Annual Meeting 2026

American Association for Cancer Research

Oncology / Cancer Research — Chicago, IL

🔬 Trial Readout

$GPCR Structure Therapeutics

Obesity / overweight (oral GLP-1 receptor agonist)

Cogent Biosciences Q1 2026 Earnings

$COGT Cogent Biosciences

Q1 2026 earnings + bezuclastinib APEX data timeline

Cytokinetics Q1 2026 Earnings

$CYTK Cytokinetics

Q1 2026 earnings + MYQORZO launch metrics + ACACIA-HCM update

Relay Therapeutics Q1 2026 Earnings

$RLAY Relay Therapeutics

Q1 2026 earnings + zovegalisib SERENA-PI3K data update

Geron Corporation Q1 2026 Earnings

$GERN Geron Corporation

Q1 2026 earnings + RYTELO commercial + sBLA update

Rhythm Pharmaceuticals Q1 2026 Earnings

$RYTM Rhythm Pharmaceuticals

Q1 2026 earnings + acquired HO commercial launch update

Protagonist Therapeutics Q1 2026 Earnings

$PTGX Protagonist Therapeutics

Q1 2026 earnings + rusfertide REVIVE Phase 3 data update

🔬 Trial Readout

(zovegalisib (RLY-2608))

$RLAY Relay Therapeutics

PIK3CA-mutant HR+/HER2- metastatic breast cancer

Phase 2 Fast Track BT Therapy

📋 Conference

ASCO Annual Meeting 2026

American Society of Clinical Oncology

Clinical Oncology — Chicago, IL

🔬 Trial Readout

(ifinatamab deruxtecan)

Daiichi Sankyo / Merck

Small cell lung cancer (SCLC) — B7-H3 ADC

Phase 2 BT Therapy

🔬 Trial Readout

(zenocutuzumab)

NRG1 fusion-positive NSCLC and pancreatic cancer

Phase 2 BT Therapy

MYQORZO (aficamten)

$CYTK Cytokinetics

Obstructive hypertrophic cardiomyopathy (oHCM)

Standard Review AdCom

$ABBV AbbVie / Arena Pharma · NDA

Eosinophilic esophagitis (EoE)

Priority Review BT Therapy

📋 Conference

EHA Congress 2026

European Hematology Association

Hematology / Blood Cancers — Barcelona, Spain

🔬 Trial Readout

(bezuclastinib)

$COGT Cogent Biosciences

Advanced systemic mastocytosis (AdvSM)

Phase 2 BT Therapy Orphan

$VRDN Viridian Therapeutics · BLA

Thyroid eye disease (TED) — chronic, active

Priority Review BT Therapy

$VERA Vera Therapeutics · BLA

IgA nephropathy (IgAN)

Priority Review BT Therapy

$SWTX SpringWorks Therapeutics · NDA

NF1-associated plexiform neurofibromas (NF1-PN)

Priority Review Orphan Rare Ped

🔬 Trial Readout

$PTGX Protagonist Therapeutics

Polycythemia vera (PV) — phlebotomy-dependent

Phase 3 Fast Track BT Therapy

Leqembi (lecanemab)

$BIIB Eisai / Biogen · sNDA

Subcutaneous formulation — early Alzheimer's disease

Standard Review Accelerated

🔬 Trial Readout

$IMVT Immunovant

Thyroid eye disease (TED)

Phase 3 BT Therapy

Landos Biopharma / Ji Xing · NDA

Ulcerative colitis (UC)

Standard Review Fast Track

$KALV KalVista Pharmaceuticals

Hereditary angioedema (HAE) — on-demand oral treatment

Standard Review AdCom

🔬 Trial Readout

$BCYC Bicycle Therapeutics

Metastatic urothelial carcinoma (Nectin-4 targeted)

Phase 2 Fast Track

📋 Conference

ESMO Annual Congress 2026

European Society for Medical Oncology

Oncology / Cancer — Berlin, Germany

$ALNY Alnylam Pharmaceuticals · NDA

Hypertension (RNA interference — twice-yearly injection)

Priority Review Fast Track BT Therapy

$REGN Regeneron · BLA

VEXAS syndrome (complement C5 inhibitor)

Priority Review BT Therapy Orphan

$KALV KalVista Pharmaceuticals · NDA

Hereditary angioedema (HAE) — on-demand oral treatment

Priority Review Orphan Fast Track

$ALNY Alnylam / Roche · NDA

Hepatitis B virus (HBV) — functional cure combination therapy

Priority Review BT Therapy

📋 Conference

ASH Annual Meeting 2026

American Society of Hematology

Hematology — New Orleans, LA

Journavx (suzetrigine)

$VRTX Vertex Pharmaceuticals · sNDA

Moderate-to-severe chronic lower back pain (NaV1.8 blocker)

Standard Review Fast Track BT Therapy

Past Catalyst Dates

$CYTK Cytokinetics

Obstructive hypertrophic cardiomyopathy (oHCM)

Date Past ✓ Approved

$ATRA Atara Biotherapeutics

Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD)

Date Past ✗ CRL

Enhertu + Perjeta

$AZN AstraZeneca / Roche

First-line HER2-positive metastatic breast cancer (combination)

Date Past upcoming

$JNJ Johnson & Johnson

Hemolytic disease of the fetus and newborn (HDFN)

Date Past upcoming

Geron Corporation Q4 2025 Earnings

$GERN Geron Corporation

Q4 2025 earnings + RYTELO Rytelo commercial update

Date Past reported

Cogent Biosciences Q4 2025 Earnings

$COGT Cogent Biosciences

Q4 2025 earnings + bezuclastinib APEX trial update

Date Past reported

Protagonist Therapeutics Q4 2025 Earnings

$PTGX Protagonist Therapeutics

Q4 2025 earnings + rusfertide REVIVE Phase 3 update

Date Past reported

Rhythm Pharmaceuticals Q4 2025 Earnings

$RYTM Rhythm Pharmaceuticals

Q4 2025 earnings + IMCIVREE acquired HO PDUFA update

Date Past reported

Relay Therapeutics Q4 2025 Earnings

$RLAY Relay Therapeutics

Q4 2025 earnings + zovegalisib SERENA-PI3K update

Date Past reported

Travere Therapeutics Q4 2025 Earnings

$TVTX Travere Therapeutics

Q4 2025 earnings + FILSPARI commercial + FSGS PDUFA update

Date Past reported

Cytokinetics Q4 2025 Earnings

$CYTK Cytokinetics

Q4 2025 earnings + MYQORZO commercial launch update

Date Past reported

$REGN Sanofi / Regeneron

Allergic fungal rhinosinusitis (AFRS) — adults and children 6+

Date Past ✓ Approved

Rocket Pharma Q4 2025 Earnings

$RCKT Rocket Pharma

Q4 2025 earnings + KRESLADI PDUFA preparation update

Date Past reported

$LNTH Lantheus Holdings

PSMA PET imaging — new formulation for prostate cancer

Date Past upcoming

Bicycle Therapeutics Q4 2025 Earnings

$BCYC Bicycle Therapeutics

Q4 2025 earnings + BT8009 DUET-2 update

Date Past reported

$ALDX Aldeyra Therapeutics

Dry eye disease (DED)

Date Past ✗ CRL

$RYTM Rhythm Pharmaceuticals

Acquired hypothalamic obesity

Date Past upcoming

💊

PDUFA

FDA target action date
🏛️

AdCom

FDA advisory committee vote
🔬

Trial Readout

Phase 2/3 data release
📋

Conference

ASCO, AACR, ASH, ESMO
📊

Earnings

Quarterly earnings calls