Every major biotech catalyst from April through June 2026 — PDUFA dates, FDA Advisory Committee meetings, Phase 3 trial readouts, and conference schedules. All entries auto-generated from the live catalyst database and refreshed every Monday.
Q2 2026 (April–June) is one of the busiest FDA decision quarters of the year. PDUFA dates mark the FDA's self-imposed deadline to approve or reject a New Drug Application (NDA) or Biologics License Application (BLA). Missing a key catalyst date can mean missing a 40–200% move in a single session — in either direction.
This calendar aggregates every tracked catalyst across PDUFA decisions, Advisory Committee votes, Phase 3 trial data readouts, and major biotech conferences. Probability of Approval (PoA) scores use FDA historical approval rates by application type and designation. The database updates every Monday so this page reflects the latest data.
| Date | Ticker | Drug / Company | Type | PoA | Status |
|---|---|---|---|---|---|
|
April 5, 2026
9d ago
|
$DNLI |
Denali Therapeutics
Hunter syndrome (MPS II) — neurologic manifestations
Priority Review
Breakthrough Therapy
Rare Pediatric Disease
Orphan Drug
|
💊 PDUFA |
93%
hist. base rate
|
✓ FDA Approved |
|
April 5, 2026
9d ago
|
View → |
American Academy of Neurology
Neurology — Los Angeles, CA
Major Conference
|
📋 Conference | — | Pending |
|
April 10, 2026
4d ago
|
$LLY |
Eli Lilly
Obesity / overweight (oral GLP-1 receptor agonist — once-daily pill)
Priority Review
Fast Track
Breakthrough Therapy
|
💊 PDUFA |
90%
hist. base rate
|
✓ FDA Approved |
|
April 13, 2026
1d ago
|
$TVTX |
Travere Therapeutics
Focal segmental glomerulosclerosis (FSGS)
Priority Review
Breakthrough Therapy
Orphan Drug
|
💊 PDUFA |
92%
hist. base rate
|
Pending |
|
April 15, 2026
1 day
|
$GERN |
Geron Corporation
Myelodysplastic syndromes (MDS) — low to intermediate risk
Priority Review
Fast Track
Orphan Drug
|
💊 PDUFA |
92%
hist. base rate
|
Pending |
|
April 17, 2026
3 days
|
View → |
American Association for Cancer Research
Oncology / Cancer Research — San Diego, CA
Major Conference
|
📋 Conference | — | Pending |
|
April 20, 2026
6 days
|
$JNJ |
Johnson & Johnson
EGFR-mutated NSCLC — first-line treatment
Priority Review
Breakthrough Therapy
|
💊 PDUFA |
92%
hist. base rate
|
Pending |
|
April 30, 2026
16 days
|
$AXSM |
Axsome Therapeutics
Alzheimer's disease agitation
Priority Review
Breakthrough Therapy
|
💊 PDUFA |
92%
hist. base rate
|
Pending |
|
April 30, 2026
16 days
|
$AZN |
AstraZeneca
PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC)
Advisory Committee
ODAC
|
🏛️ AdCom |
92%
hist. base rate
|
Pending |
|
April 30, 2026
16 days
|
$AZN |
AstraZeneca
HR+/HER2- advanced breast cancer — first-line with emergent ESR1 mutation
Advisory Committee
ODAC
|
🏛️ AdCom |
85%
hist. base rate
|
Pending |
|
May 5, 2026
21 days
|
$COGT |
Cogent Biosciences
Q1 2026 earnings + bezuclastinib APEX data timeline
Earnings
|
📊 Earnings | — | Pending |
|
May 6, 2026
22 days
|
$SWTX |
SpringWorks Therapeutics
Q1 2026 earnings + mirdametinib PDUFA July 10 preparation update
Earnings
|
📊 Earnings | — | Pending |
|
May 6, 2026
22 days
|
$VRDN |
Viridian Therapeutics
Q1 2026 earnings + veligrotug PDUFA preparation + VRDN-003 Phase 3 update
Earnings
|
📊 Earnings | — | Pending |
|
May 6, 2026
22 days
|
$CYTK |
Cytokinetics
Q1 2026 earnings + MYQORZO launch metrics + ACACIA-HCM update
Earnings
|
📊 Earnings | — | Pending |
|
May 7, 2026
23 days
|
$ARVN |
Arvinas / Pfizer
Q1 2026 earnings + vepdegestrant PDUFA June 5 preparation update
Earnings
|
📊 Earnings | — | Pending |
|
May 7, 2026
23 days
|
$GERN |
Geron Corporation
Q1 2026 earnings + RYTELO commercial + sBLA update
Earnings
|
📊 Earnings | — | Pending |
|
May 7, 2026
23 days
|
$RLAY |
Relay Therapeutics
Q1 2026 earnings + zovegalisib SERENA-PI3K data update
Earnings
|
📊 Earnings | — | Pending |
|
May 7, 2026
23 days
|
$PRAX |
Praxis Precision Medicines
Q1 2026 earnings + ulixacaltamide + relutrigine PDUFA updates
Earnings
|
📊 Earnings | — | Pending |
|
May 8, 2026
24 days
|
$VERA |
Vera Therapeutics
Q1 2026 earnings + atacicept PDUFA July 7 commercial preparation update
Earnings
|
📊 Earnings | — | Pending |
|
May 8, 2026
24 days
|
$PTGX |
Protagonist Therapeutics
Q1 2026 earnings + rusfertide REVIVE Phase 3 data update
Earnings
|
📊 Earnings | — | Pending |
|
May 8, 2026
24 days
|
$RYTM |
Rhythm Pharmaceuticals
Q1 2026 earnings + acquired HO commercial launch update
Earnings
|
📊 Earnings | — | Pending |
|
May 14, 2026
30 days
|
View → |
European Society for Medical Oncology
Breast Oncology — Berlin, Germany
Major Conference
|
📋 Conference | — | Pending |
|
May 15, 2026
31 days
|
$VRDN |
Viridian Therapeutics
Active thyroid eye disease (TED) — subcutaneous anti-FcRn antibody
Phase 3
Fast Track
|
🔬 Trial Readout | — | Pending |
|
May 15, 2026
31 days
|
$RLAY |
Relay Therapeutics
PIK3CA-mutant HR+/HER2- metastatic breast cancer
Phase 2
Fast Track
Breakthrough Therapy
|
🔬 Trial Readout | — | Pending |
|
May 29, 2026
45 days
|
View → |
American Society of Clinical Oncology
Clinical Oncology — Chicago, IL
Major Conference
|
📋 Conference | — | Pending |
|
May 30, 2026
46 days
|
View → |
Daiichi Sankyo / Merck
Small cell lung cancer (SCLC) — B7-H3 ADC
Phase 2
Priority Review
Breakthrough Therapy
|
🔬 Trial Readout | — | Pending |
|
June 1, 2026
48 days
|
$MRUS |
Merus NV
NRG1 fusion-positive NSCLC and pancreatic cancer
Phase 2
Breakthrough Therapy
Priority Review
|
🔬 Trial Readout | — | Pending |
|
June 1, 2026
48 days
|
$RHHBY |
Roche / Genentech
ER+/HER2- first-line advanced breast cancer (1L)
Phase 3
|
🔬 Trial Readout | — | Pending |
|
June 3, 2026
50 days
|
$CYTK |
Cytokinetics
Obstructive hypertrophic cardiomyopathy (oHCM)
Advisory Committee
|
🏛️ AdCom |
85%
hist. base rate
|
✓ FDA Approved |
|
June 5, 2026
52 days
|
$ARVN |
Arvinas / Pfizer
ESR1-mutated ER+/HER2- advanced or metastatic breast cancer (2L+)
Fast Track
|
💊 PDUFA |
85%
hist. base rate
|
Pending |
|
June 8, 2026
55 days
|
$ABBV |
AbbVie / Arena Pharma
Eosinophilic esophagitis (EoE)
Priority Review
Breakthrough Therapy
|
💊 PDUFA |
90%
hist. base rate
|
Pending |
|
June 11, 2026
58 days
|
View → |
European Hematology Association
Hematology / Blood Cancers — Barcelona, Spain
Major Conference
|
📋 Conference | — | Pending |
|
June 15, 2026
62 days
|
$COGT |
Cogent Biosciences
Advanced systemic mastocytosis (AdvSM)
Phase 2
Breakthrough Therapy
Orphan Drug
|
🔬 Trial Readout | — | Pending |
|
June 15, 2026
62 days
|
$CYTK |
Cytokinetics
Non-obstructive hypertrophic cardiomyopathy (nHCM)
Phase 3
Breakthrough Therapy
|
🔬 Trial Readout | — | Pending |
|
June 22, 2026
69 days
|
View → |
International Society on Thrombosis and Haemostasis
Hematology / Hemostasis — Singapore
Major Conference
|
📋 Conference | — | Pending |
|
June 30, 2026
77 days
|
$MBRX |
Moleculin Biotech
Relapsed/refractory AML — MIRACLE Phase 2B/3 interim readout
Phase 2B/3
Orphan Drug
|
🔬 Trial Readout | — | Pending |
|
June 30, 2026
77 days
|
$VRDN |
Viridian Therapeutics
Thyroid eye disease (TED) — chronic, active
Priority Review
Breakthrough Therapy
|
💊 PDUFA |
88%
hist. base rate
|
Pending |
|
June 30, 2026
77 days
|
$AZN |
AstraZeneca
HR+/HER2- advanced breast cancer — 1L with emergent ESR1 mutation (with CDK4/6 inhibitor)
Breakthrough Therapy
|
💊 PDUFA |
85%
hist. base rate
|
Pending |
|
June 30, 2026
77 days
|
$AZN |
AstraZeneca
PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) — with abiraterone + ADT
Breakthrough Therapy
|
💊 PDUFA |
92%
hist. base rate
|
Pending |
Each row in the table represents a binary event — a date when a drug could be approved, rejected, or delayed. For biotech investors, these dates are the highest-volatility moments in a stock's lifecycle.
FDA's self-imposed target date to approve or issue a Complete Response Letter (CRL). The highest-stakes binary event for most small-cap biotechs.
Advisory Committee panel votes on whether a drug should be approved. The FDA follows AdCom recommendations the majority of the time.
Phase 3 trial data releases. Positive data can trigger NDA filing; failure can be catastrophic for single-asset biotechs. PoA scores for trials use Phase 3 historical success rates (~58%).
Historical Probability of Approval — an evidence-based base rate, not a prediction. NDA standard = 85%, NDA priority = 90%, orphan = 93%. A prior CRL reduces PoA by ~28%.
Ready to trade these catalysts?
Understanding what these dates mean is step one. Trading them profitably — position sizing for binary events, options strategies around IV crush, reading AdCom signals — is a different skill.
How to Trade PDUFA Dates: Strategy Guide →Don't Miss a Q2 Catalyst
Get ahead of PDUFA decisions and trial readouts before the market moves.
Follow on Substack →