● 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 29

🏛️ AdCom 4

🔬 Trial Readout 12

📋 Conference 8

📊 Earnings 11

64

Upcoming Catalysts

29

PDUFA Dates

24

Priority Review

85–93%

NDA/BLA Approval Range

Upcoming Catalysts

Sorted by date · All dates are target / expected dates

This Week: 3

This Month: 8

Upcoming: 53

AVLAYAH (tividenofusp alfa-eknm)

$DNLI Denali Therapeutics · BLA

Hunter syndrome (MPS II) — neurologic manifestations

Priority Review BT Therapy Rare Ped

📋 Conference

AAN Annual Meeting 2026

American Academy of Neurology

Neurology — Los Angeles, CA

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

(camizestrant (NDA 220359))

$AZN AstraZeneca

HR+/HER2- advanced breast cancer — first-line with emergent ESR1 mutation

Standard Review AdCom ODAC

Truqap (capivasertib (Truqap) + abir...)

$AZN AstraZeneca

PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC)

Standard Review AdCom ODAC

Auvelity (supplemental) (dextromethorphan HBr / bupro...)

$AXSM Axsome Therapeutics · sNDA

Alzheimer's disease agitation

Priority Review BT Therapy

Cogent Biosciences Q1 2026 Earnings

$COGT Cogent Biosciences

Q1 2026 earnings + bezuclastinib APEX data timeline

SpringWorks Therapeutics Q1 2026 Earnings

$SWTX SpringWorks Therapeutics

Q1 2026 earnings + mirdametinib PDUFA July 10 preparation update

Cytokinetics Q1 2026 Earnings

$CYTK Cytokinetics

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

Viridian Therapeutics Q1 2026 Earnings

$VRDN Viridian Therapeutics

Q1 2026 earnings + veligrotug PDUFA preparation + VRDN-003 Phase 3 update

Geron Corporation Q1 2026 Earnings

$GERN Geron Corporation

Q1 2026 earnings + RYTELO commercial + sBLA update

Arvinas Q1 2026 Earnings

$ARVN Arvinas / Pfizer

Q1 2026 earnings + vepdegestrant PDUFA June 5 preparation update

Relay Therapeutics Q1 2026 Earnings

$RLAY Relay Therapeutics

Q1 2026 earnings + zovegalisib SERENA-PI3K data update

Praxis Precision Medicines Q1 2026 Earnings

$PRAX Praxis Precision Medicines

Q1 2026 earnings + ulixacaltamide + relutrigine PDUFA updates

Rhythm Pharmaceuticals Q1 2026 Earnings

$RYTM Rhythm Pharmaceuticals

Q1 2026 earnings + acquired HO commercial launch update

Vera Therapeutics Q1 2026 Earnings

$VERA Vera Therapeutics

Q1 2026 earnings + atacicept PDUFA July 7 commercial preparation update

Protagonist Therapeutics Q1 2026 Earnings

$PTGX Protagonist Therapeutics

Q1 2026 earnings + rusfertide REVIVE Phase 3 data update

📋 Conference

ESMO Breast Cancer Congress 2026

European Society for Medical Oncology

Breast Oncology — Berlin, Germany

🔬 Trial Readout

(zovegalisib (RLY-2608))

$RLAY Relay Therapeutics

PIK3CA-mutant HR+/HER2- metastatic breast cancer

Phase 2 Fast Track BT Therapy

🔬 Trial Readout

(VRDN-003 (subcutaneous formu...)

$VRDN Viridian Therapeutics

Active thyroid eye disease (TED) — subcutaneous anti-FcRn antibody

Phase 3 Fast Track

📋 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

(giredestrant + everolimus — ...)

$RHHBY Roche / Genentech

ER+/HER2- first-line advanced breast cancer (1L)

🔬 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

(vepdegestrant (ARV-471))

$ARVN Arvinas / Pfizer · NDA

ESR1-mutated ER+/HER2- advanced or metastatic breast cancer (2L+)

Standard Review Fast Track

$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

MYQORZO (aficamten — ACACIA-HCM)

$CYTK Cytokinetics

Non-obstructive hypertrophic cardiomyopathy (nHCM)

Phase 3 BT Therapy

🔬 Trial Readout

(bezuclastinib)

$COGT Cogent Biosciences

Advanced systemic mastocytosis (AdvSM)

Phase 2 BT Therapy Orphan

📋 Conference

ISTH Congress 2026

International Society on Thrombosis and Haemostasis

Hematology / Hemostasis — Singapore

(camizestrant (AZD9833))

$AZN AstraZeneca · NDA

HR+/HER2- advanced breast cancer — 1L with emergent ESR1 mutation (with CDK4/6 inhibitor)

Standard Review BT Therapy

Truqap (supplemental) (capivasertib (Truqap) + abir...)

$AZN AstraZeneca · sNDA

PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) — with abiraterone + ADT

Standard Review BT Therapy

$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

$CELC Celcuity · NDA

HR+/HER2-/PIK3CA wild-type advanced breast cancer (2nd-line post CDK4/6i)

Priority Review BT Therapy Fast Track

🔬 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

(denecimig (Mim8))

$NVO Novo Nordisk · BLA

Hemophilia A (with or without inhibitors) — monthly/biweekly/weekly subcutaneous prophylaxis

Standard Review Fast Track

🔬 Trial Readout

$IMVT Immunovant

Thyroid eye disease (TED)

Phase 3 BT Therapy

(ulixacaltamide (PRAX-944))

$PRAX Praxis Precision Medicines · NDA

Essential tremor (ET) — first therapy specifically designed for ET

Priority Review BT Therapy Fast Track

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

$CAPR Capricor Therapeutics · BLA

Duchenne muscular dystrophy (DMD) cardiomyopathy

Standard Review Orphan Rare Ped Fast Track

BESREMi (supplemental) (ropeginterferon alfa-2b-njft)

PharmaEssentia · sBLA

Essential thrombocythemia (ET) — label expansion from polycythemia vera

Standard Review Orphan

🔬 Trial Readout

$BCYC Bicycle Therapeutics

Metastatic urothelial carcinoma (Nectin-4 targeted)

Phase 2 Fast Track

🔬 Trial Readout

(camizestrant — SERENA-4)

$AZN AstraZeneca

HR+/HER2- advanced breast cancer — first-line (frontline, traditional design)

📋 Conference

ESMO Annual Congress 2026

European Society for Medical Oncology

Oncology / Cancer — Berlin, Germany

🔬 Trial Readout

Rytelo (imetelstat (Rytelo) — IMpact...)

$GERN Geron Corporation

Myelofibrosis (MF) — overall survival analysis

$ALNY Alnylam Pharmaceuticals · NDA

Hypertension (RNA interference — twice-yearly injection)

Priority Review Fast Track BT Therapy

$PRAX Praxis Precision Medicines · NDA

SCN2A- and SCN8A-related developmental and epileptic encephalopathies (DEEs)

Priority Review BT Therapy Orphan

$ROIV Priovant Therapeutics / Roivant Sciences · NDA

Dermatomyositis (DM) — inflammatory myopathy

Priority Review Orphan 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

MYQORZO (supplemental) (aficamten (MAPLE-HCM sNDA))

$CYTK Cytokinetics · sNDA

Obstructive HCM — aficamten vs standard of care beta-blocker as monotherapy alternative

Standard Review Fast Track

$ALNY Alnylam / Roche · NDA

Hepatitis B virus (HBV) — functional cure combination therapy

Priority Review BT Therapy

Journavx (suzetrigine)

$VRTX Vertex Pharmaceuticals · sNDA

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

Standard Review Fast Track BT Therapy

📋 Conference

ASH Annual Meeting 2026

American Society of Hematology

Hematology — New Orleans, LA

📋 Past Catalyst Dates — FDA decisions shown

$CYTK Cytokinetics

Obstructive hypertrophic cardiomyopathy (oHCM)

✓ FDA Approved

$ATRA Atara Biotherapeutics

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

✗ Complete Response Letter (CRL)

Enhertu + Perjeta

$AZN AstraZeneca / Roche

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

✓ FDA Approved

FDA Approved on 2025-12-15 (BLA761139). Source: FDA Drugs@FDA database.

Decision: December 15, 2025

$JNJ Johnson & Johnson

Hemolytic disease of the fetus and newborn (HDFN)

⏳ Outcome Not Yet Recorded

Protagonist Therapeutics Q4 2025 Earnings

$PTGX Protagonist Therapeutics

Q4 2025 earnings + rusfertide REVIVE Phase 3 update

Geron Corporation Q4 2025 Earnings

$GERN Geron Corporation

Q4 2025 earnings + RYTELO Rytelo commercial update

Cogent Biosciences Q4 2025 Earnings

$COGT Cogent Biosciences

Q4 2025 earnings + bezuclastinib APEX trial update

Rhythm Pharmaceuticals Q4 2025 Earnings

$RYTM Rhythm Pharmaceuticals

Q4 2025 earnings + IMCIVREE acquired HO PDUFA update

Relay Therapeutics Q4 2025 Earnings

$RLAY Relay Therapeutics

Q4 2025 earnings + zovegalisib SERENA-PI3K update

📋 Conference

ASCO Genitourinary Cancers Symposium 2026

American Society of Clinical Oncology GU

Genitourinary Oncology — San Francisco, CA

Travere Therapeutics Q4 2025 Earnings

$TVTX Travere Therapeutics

Q4 2025 earnings + FILSPARI commercial + FSGS PDUFA update

Cytokinetics Q4 2025 Earnings

$CYTK Cytokinetics

Q4 2025 earnings + MYQORZO commercial launch update

$REGN Sanofi / Regeneron

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

✓ FDA Approved

Rocket Pharma Q4 2025 Earnings

$RCKT Rocket Pharma

Q4 2025 earnings + KRESLADI PDUFA preparation update

$LNTH Lantheus Holdings

PSMA PET imaging — new higher-concentration formulation for prostate cancer

✓ FDA Approved

FDA APPROVED March 6, 2026 — on PDUFA target date. Approved as PYLARIFY TruVu, a new higher-radioactivity-concentration formulation of piflufolastat F-18 enabling larger batches (~50% bigger) and broader geographic distribution. 505(b)(2) pathway using OSPREY and CONDOR data. Commercial launch planned Q4 2026 with phased geographic rollout.

Decision: March 6, 2026

Bicycle Therapeutics Q4 2025 Earnings

$BCYC Bicycle Therapeutics

Q4 2025 earnings + BT8009 DUET-2 update

$ALDX Aldeyra Therapeutics

Dry eye disease (DED)

✗ Complete Response Letter (CRL)

🔬 Trial Readout

aleniglipron (GSBR-1290)

$GPCR Structure Therapeutics

Obesity / overweight (oral GLP-1 receptor agonist)

$RYTM Rhythm Pharmaceuticals

Acquired hypothalamic obesity

✓ FDA Approved

FDA APPROVED March 19, 2026 — 1 day before PDUFA target date of March 20. First and only FDA-approved therapy for acquired hypothalamic obesity (HO) in adults and pediatric patients 4+. Broad label not limited to tumor-related HO. Supported by Phase 3 TRANSCEND trial (18.4% placebo-adjusted BMI reduction at 52 weeks, n=142). EMA CHMP positive opinion also received March 26, 2026.

Decision: March 19, 2026

$RCKT Rocket Pharma

Leukocyte adhesion deficiency-I (LAD-I)

✓ FDA Approved

FDA APPROVED March 26, 2026 — accelerated approval, 2 days before PDUFA target date of March 28. First FDA-approved gene therapy for severe LAD-I. Also received Rare Pediatric Disease Priority Review Voucher.

Decision: March 26, 2026

📋 Conference

ACC Scientific Sessions 2026

American College of Cardiology

Cardiology — Chicago, IL

💊

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

PoA scores apply to PDUFA and AdCom entries only.

NDA (standard)	85%
NDA (priority)	90%
BLA (standard)	80%
BLA (priority)	88%
sNDA / sBLA	92%
Orphan / Rare disease	93%
Phase III readout	58%
Phase II	33%
Phase I	70%
CRL resubmission	−28%

Based on FDA historical approval rates by submission type (2015–2025). Source: FDA CDER Annual Reports. Sentiment-adjusted PoA coming soon (powered by xAI).