🧬 Biotech Catalyst Calendar

Updated daily · catalystalert.io + dansfera.com Admin
46
Upcoming
2
This Month
0
Trial Readouts
46
PDUFA Dates
0
AdCom Votes
Type: All 🔬 Trial 💊 PDUFA 🏛️ AdCom 📊 Earnings
Mkt Size: All ≥$1B ≥$5B ≥$10B ≥$50B
Date Ticker Company Drug Type Phase PoA Mkt Size Notes
2026-04-28
Today 		INSM Insmed Incorporated Arikayce™ PDUFA Phase 2 — $6B For NTM lung disease. sNDA filing. Extracted from SEC filing: 8-K
2026-04-30
in 2 days 		AXSM Axsome Therapeutics · sNDA Alzheimer's disease agitation Auvelity (supplemental) (dextromethorphan HBr / bupro PDUFA — 92% $4B APR 30 2026 2 days 💊 PDUFA Auvelity (supplemental) (dextromethorphan HBr / bupro...) $AXSM
2026-06-05
in 177 days 		ARVN Arvinas / Pfizer · NDA ESR1-mutated ER+/HER2- advanced or metastatic breast cancer (2L+) vepdegestrant (ARV-471 PDUFA — 85% $10B JUN 5 2026 38 days 💊 PDUFA (vepdegestrant (ARV-471)) $ARVN Arvinas / Pfizer · NDA ESR1-mut
2026-06-08
in 180 days 		ABBV AbbVie / Arena Pharma · NDA Eosinophilic esophagitis (EoE) cendakimab PDUFA — 90% $6B JUN 8 2026 41 days 💊 PDUFA (cendakimab) $ABBV AbbVie / Arena Pharma · NDA Eosinophilic eso
2026-06-16
in 188 days 		SNY Sanofi Fitusiran PDUFA Phase 3 — $8B For hemophilia. BLA filing. Extracted from SEC filing: 6-K
2026-06-18
in 190 days 		IMCR Immunocore Holdings plc Tebentafusp PDUFA Phase 3 — $8B For unresectable or metastatic uveal melanoma. BLA filing. Extracted from SEC filing: 8-K
2026-06-28
in 200 days 		MNKD MannKind Corporation Afrezza PDUFA Phase 3 — $8B For Type 1 diabetes. NDA filing. Extracted from SEC filing: 8-K
2026-06-30
in 202 days 		AZN AstraZeneca · NDA HR+/HER2- advanced breast cancer — 1L with emergent ESR1 mutation (with CDK4/6 inh camizestrant (AZD9833 PDUFA — 85% $12B JUN 30 2026 63 days 💊 PDUFA (camizestrant (AZD9833)) $AZN AstraZeneca · NDA HR+/HER2- adva
2026-06-30
in 202 days 		AZN AstraZeneca · sNDA PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) — wit Truqap (supplemental) (capivasertib (Truqap) + abir PDUFA — 92% $8B JUN 30 2026 63 days 💊 PDUFA Truqap (supplemental) (capivasertib (Truqap) + abir...) $AZN A
2026-06-30
in 202 days 		VRDN Viridian Therapeutics · BLA Thyroid eye disease (TED) — chronic, active veligrotug PDUFA — 88% $2B JUN 30 2026 63 days 💊 PDUFA (veligrotug) $VRDN Viridian Therapeutics · BLA Thyroid eye dis
2026-07-07
in 279 days 		VERA Vera Therapeutics · BLA IgA nephropathy (IgAN) atacicept PDUFA — 88% $8B JUL 7 2026 70 days 💊 PDUFA (atacicept) $VERA Vera Therapeutics · BLA IgA nephropathy (IgAN
2026-07-10
in 282 days 		SWTX SpringWorks Therapeutics · NDA NF1-associated plexiform neurofibromas (NF1-PN) mirdametinib PDUFA — 93% $2B JUL 10 2026 73 days 💊 PDUFA (mirdametinib) $SWTX SpringWorks Therapeutics · NDA NF1-associ
2026-07-17
in 289 days 		CELC Celcuity · NDA HR+/HER2-/PIK3CA wild-type advanced breast cancer (2nd-line post CDK4/6i) gedatolisib PDUFA — 90% $1B JUL 17 2026 80 days 💊 PDUFA (gedatolisib) $CELC Celcuity · NDA HR+/HER2-/PIK3CA wild-type
2026-07-25
in 297 days 		BIIB Eisai / Biogen · sNDA Subcutaneous formulation — early Alzheimer's disease Leqembi (lecanemab PDUFA — 92% $15B JUL 25 2026 88 days 💊 PDUFA Leqembi (lecanemab) $BIIB Eisai / Biogen · sNDA Subcutaneous f
2026-07-29
in 301 days 		NVO Novo Nordisk · BLA Hemophilia A (with or without inhibitors) — monthly/biweekly/weekly subcutaneous denecimig (Mim8 PDUFA — 80% $1B JUL 29 2026 92 days 💊 PDUFA (denecimig (Mim8)) $NVO Novo Nordisk · BLA Hemophilia A (with
2026-08-01
in 373 days 		MRNA Moderna, Inc. mRNA-1010 PDUFA Phase 3 — $8B For Influenza vaccine. FDA reversed its Refusal-to-File decision on Moderna's mRNA-1010 fl
2026-08-05
in 377 days 		MRNA Moderna, Inc. Influenza Vaccine PDUFA Phase 3 — $15B For influenza. The FDA reversed its earlier Refusal-to-File decision and agreed to review
2026-08-17
in 389 days 		PRAX Praxis Precision Medicines · NDA Essential tremor (ET) — first therapy specifically designed for ET ulixacaltamide (PRAX-944 PDUFA — 90% $1B AUG 17 2026 111 days 💊 PDUFA (ulixacaltamide (PRAX-944)) $PRAX Praxis Precision Medicines
2026-08-20
in 392 days 		ARGX argenx SE Efgartigimod IV PDUFA Phase 3 — $1B For generalized myasthenia gravis. BLA filing. Extracted from SEC filing: 6-K
2026-08-22
in 394 days 		CAPR Capricor Therapeutics · BLA Duchenne muscular dystrophy (DMD) cardiomyopathy deramiocel PDUFA — 67% $1B AUG 22 2026 116 days 💊 PDUFA (deramiocel) $CAPR Capricor Therapeutics · BLA Duchenne muscu
2026-08-25
in 397 days 		RHHBY Roche Holding AG Iberdomide PDUFA Phase 2 — $15B NDA filing. AI-extracted from news: FDA Accepts Bristol Myers Squibb (BMY) NDA for Iberdom
2026-09-02
in 474 days 		CFOO China Foods Holdings Ltd. Zurletrectinib PDUFA NDA — $3B For pediatric solid tumors. NDA filing. AI-extracted from news: InnoCare’s next-generation
2026-09-02
in 474 days 		TAK TAKEDA PHARMACEUTICAL CO LTD Rusfertide PDUFA NDA — $2B For Polycythemia Vera. NDA filing. AI-extracted from news: Takeda and Protagonist Announce
2026-09-15
in 487 days 		ALNY Alnylam Pharmaceuticals · NDA Hypertension (RNA interference — twice-yearly injection) zilebesiran PDUFA — 90% $4B SEP 15 2026 140 days 💊 PDUFA (zilebesiran) $ALNY Alnylam Pharmaceuticals · NDA Hypertensio
2026-09-27
in 499 days 		PRAX Praxis Precision Medicines · NDA SCN2A- and SCN8A-related developmental and epileptic encephalopathi relutrigine PDUFA — 93% $1B SEP 27 2026 152 days 💊 PDUFA (relutrigine) $PRAX Praxis Precision Medicines · NDA SCN2A- a
2026-09-30
in 502 days 		ROIV Priovant Therapeutics / Roivant Sciences · NDA Dermatomyositis (DM) — inflammatory myopathy brepocitinib PDUFA — 93% $2B SEP 30 2026 155 days 💊 PDUFA (brepocitinib) $ROIV Priovant Therapeutics / Roivant Sciences
2026-10-01
in 573 days 		REGN Regeneron · BLA VEXAS syndrome (complement C5 inhibitor) pozelimab PDUFA — 93% $2B OCT 1 2026 156 days 💊 PDUFA (pozelimab) $REGN Regeneron · BLA VEXAS syndrome (complement C
2026-10-01
in 573 days 		GSK GSK plc Belumosudil PDUFA NDA — $2B For chronic graft-versus-host disease. NDA filing. Extracted from SEC filing: 6-K
2026-10-20
in 592 days 		KALV KalVista Pharmaceuticals · NDA Hereditary angioedema (HAE) — on-demand oral treatment donidalorsen PDUFA — 93% $2B OCT 20 2026 175 days 💊 PDUFA (donidalorsen) $KALV KalVista Pharmaceuticals · NDA Hereditar
2026-10-29
in 601 days 		MRK MERCK tildrakizumab PDUFA Phase 2 — $12B For Adults with Active Psoriatic Arthritis If the sBLA is approved. sbla filing. AI-extra
2026-10-30
in 602 days 		CYTK Cytokinetics · sNDA Obstructive HCM — aficamten vs MYQORZO (supplemental) (aficamten (MAPLE-HCM sNDA PDUFA — 92% $8B OCT 30 2026 185 days 💊 PDUFA MYQORZO (supplemental) (aficamten (MAPLE-HCM sNDA)) $CYTK Cyt
2026-11-01
in 673 days 		SMMT Summit Therapeutics Inc. Drug: Ivonescimab Injection PDUFA Phase 3 — $8B Extracted from: Summit gets November PDUFA date for its PD-1xVEGF bispecific
2026-11-10
in 682 days 		ALNY Alnylam / Roche · NDA Hepatitis B virus (HBV) — functional cure combination therapy elebsiran PDUFA — 90% $4B NOV 10 2026 196 days 💊 PDUFA (elebsiran) $ALNY Alnylam / Roche · NDA Hepatitis B virus (HB
2026-12-01
in 773 days 		MRK MERCK Zanzalintinib PDUFA Phase 3 — $8B For Renal cell carcinoma (RCC). Exelixis presented data on Zanzalintinib for renal cell ca
2026-12-05
in 777 days 		VRTX Vertex Pharmaceuticals · sNDA Moderate-to-severe chronic lower back pain (NaV1.8 blocker) Journavx (suzetrigine PDUFA — 92% $2B DEC 5 2026 221 days 💊 PDUFA Journavx (suzetrigine) $VRTX Vertex Pharmaceuticals · sNDA Mod
2026-12-27
in 799 days 		IDIA Idorsia Pharmaceuticals Ltd. BOND-003 PDUFA NDA — $1B BLA submitted. AI-extracted from: CG Oncology Conference: Credo Posts 75.5% CR in BOND-003
2026-12-27
in 799 days 		CNTA Centessa Pharmaceuticals plc epilepsy drug PDUFA NDA — $15B For epilepsy. NDA submitted. AI-extracted from: Praxis tees up another approval filing; Ge
2027-01-01
in 9673 days 		EXEL Exelixis, Inc. Cabozantinib PDUFA Phase 3 — $6B For advanced hepatocellular carcinoma. sNDA filing. Extracted from SEC filing: 8-K
2027-01-01
in 9673 days 		TAK TAKEDA PHARMACEUTICAL CO LTD Potential Polycythemia Vera Treatment PDUFA NDA — $2B For Polycythemia Vera. NDA filing. AI-extracted from news: Takeda, Protagonist Say FDA Acc
2027-01-28
in 9700 days 		VNDA Vanda Pharmaceuticals Inc. Imsidolimab PDUFA Phase 2 — $3B For Rare Skin Disease. BLA filing. AI-extracted from news: Vanda Pharmaceuticals Says US F
2027-02-12
in 9784 days 		OCUL Ocular Therapeutix, Inc. AXPAXLI PDUFA NDA — $12B For wet-AMD. NDA submitted. AI-extracted from: Ocular: 'Buy' As AXPAXLI Program For Wet-AM
2027-02-17
in 9789 days 		MLTX MoonLake Immunotherapeutics — PDUFA NDA — $8B For inflammatory arthritis. BLA submitted. AI-extracted from: MoonLake has 'confidence' ah
2027-03-01
in 9873 days 		GSK GSK plc Feladilimab PDUFA Phase 2 — $15B For multiple myeloma. BLA filing. Extracted from SEC filing: 6-K
2027-03-04
in 9876 days 		XENE Xenon Pharmaceuticals Inc. Azetukalner PDUFA Phase 3 — $15B For epilepsy. NDA submitted. AI-extracted from: Xenon gets Phase 3 win with epilepsy drug,
2027-04-04
in 9976 days 		CFOO China Foods Holdings Ltd. Trastuzumab Pamirtecan (T-Pam, DB-1303, BNT323) PDUFA NDA — $12B For Unresectable or Metastatic HER2-Positive Adult Breast Cancer. BLA accepted. AI-extract
2027-04-10
in 9982 days 		NHPAP National Healthcare Properties, Inc. MAIWEIJIAN (Denosumab) PDUFA NDA — $4B sBLA accepted. AI-extracted from: Mabwell Announces Acceptance of Supplemental Biologics L