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Upcoming PDUFA Dates

FDA approval decision deadlines for biotech drugs

50 Active Signals
REGNRegeneron PharmaceuticalsAntibody Therapeutics
fianlimab — adjuvant melanoma
F
34/100
BEAMBeam TherapeuticsBase Editing
BEAM-101 — sickle cell disease
B
71/100
INCYIncyte CorporationOncology
povorcitinib — hidradenitis suppurativa
C
60/100
VRTXVertex PharmaceuticalsGene Therapy
suzetrigine (VX-548) — moderate-to-severe acute pain sNDA
C
55/100
IONSIonis PharmaceuticalsAntisense Therapeutics
donidalorsen — hereditary angioedema
B
68/100
NUVLNuvalent IncOncology
zidesamtinib — ROS1+ NSCLC
C
57/100
IMVTImmunovant IncAutoimmune
batoclimab — thyroid eye disease
C
58/100
MRUSMerus NVBispecific Antibodies
zenocutuzumab — NRG1 fusion+ NSCLC/PDAC
C
55/100
MRNAModerna IncmRNA Therapeutics
mRNA-1283 — RSV vaccine adult
C
53/100
NBIXNeurocrine BiosciencesNeuroscience
ingrezza (valbenazine) — Huntington's disease chorea sNDA
D
50/100
CLDXCelldex TherapeuticsImmuno-Oncology
barzolvolimab — chronic spontaneous urticaria
C
50/100
RCKTRocket PharmaceuticalsGene Therapy
beremagene geperpavec — dystrophic epidermolysis bullosa
C
51/100
VKTXViking TherapeuticsMetabolic Disease
VK2735 — obesity subcutaneous
C
53/100
EXELExelixis IncOncology
zanzalintinib — renal cell carcinoma
C
55/100
SAGESage TherapeuticsNeuroscience
SAGE-718 — Huntington's disease cognitive impairment
C
50/100
AXSMAxsome TherapeuticsNeuroscience
AXS-05 — major depressive disorder adjunctive
D
42/100
MDGLMadrigal PharmaceuticalsLiver Disease
resmetirom — NASH/MASH pediatric sNDA
D
45/100
SRPTSarepta TherapeuticsGene Therapy
elevidys (delandistrogene moxeparvovec) — DMD expanded sNDA
D
44/100
ASNDAscendis PharmaRare Endocrine
tolebrutinib — relapsing MS
F
32/100
NTLAIntellia TherapeuticsGene Editing
NTLA-2001 — ATTR cardiomyopathy
D
44/100
LLYEli Lilly and CompanyDiabetes/Oncology
retatrutide — obesity GLP-1/GIP/glucagon
C
53/100
BMRNBioMarin PharmaceuticalRare Disease
BMN 307 — phenylketonuria
D
36/100
PTGXProtagonist TherapeuticsPeptide Therapeutics
setanaxib — idiopathic pulmonary fibrosis
D
37/100
CYTKCytokinetics IncCardiovascular
aficamten — obstructive HCM sNDA
D
37/100
IOVAIovance BiotherapeuticsCell Therapy
lifileucel — melanoma sNDA broader indication
C
64/100
AGENAgenus IncImmuno-Oncology
botensilimab + balstilimab — recurrent/metastatic cervical cancer
C
63/100
ARDXArdelyx IncNephrology
tenapanor — hyperphosphatemia in dialysis
D
37/100
FOLDAmicus TherapeuticsRare Disease
pegunigalsidase alfa — Fabry disease pediatric
C
62/100
DNLIDenali TherapeuticsNeuroscience
DNL343 — ALS
C
62/100
RAREUltragenyx PharmaceuticalRare Disease
setrusumab — osteogenesis imperfecta
C
63/100
CRSPCRISPR TherapeuticsGene Editing
exagamglogene autotemcel — transfusion-dependent beta-thal
D
43/100
EDITEditas MedicineGene Editing
EDIT-301 — sickle cell disease
C
62/100
SNDXSyndax PharmaceuticalsOncology
entinostat + exemestane — HR+ HER2- breast cancer
C
63/100
BMYBristol-Myers SquibbOncology
milvexian — stroke prevention/AF
F
35/100
IMVTImmunovant IncAutoimmune
batoclimab — myasthenia gravis
C
58/100
ARQTArcus BiosciencesImmuno-Oncology
roflumilast foam — seborrheic dermatitis
F
29/100
FATEFate TherapeuticsCell Therapy
FT576 — multiple myeloma
C
62/100
APLSApellis PharmaceuticalsComplement Inhibitors
pegcetacoplan — geographic atrophy expanded
D
36/100
MIRMMirum PharmaceuticalsLiver Disease
maralixibat — biliary atresia pediatric
D
37/100
LLYEli Lilly and CompanyDiabetes/Oncology
orforglipron — obesity oral GLP-1
C
53/100
JNJJohnson & JohnsonDiversified Pharma
nipocalimab — fetal/neonatal alloimmune thrombocytopenia
C
60/100
CGEMCullinan OncologyOncology
REC-994 — spinocerebellar ataxia type 3
D
37/100
ALNYAlnylam PharmaceuticalsRNAi Therapeutics
ALN-AGT — resistant hypertension
F
28/100
GILDGilead SciencesAntiviral
lenacapavir — HIV treatment once-weekly oral
F
24/100
BMYBristol-Myers SquibbOncology
relatlimab + nivolumab — adjuvant gastric cancer
F
35/100
IMVTImmunovant IncAutoimmune
batoclimab — chronic inflammatory demyelinating polyneuropathy
C
58/100
NUVLNuvalent IncOncology
zidesamtinib — pediatric NSCLC
C
57/100
LLYEli Lilly and CompanyDiabetes/Oncology
lebrikizumab (Ebglyss) — atopic dermatitis sNDA
C
53/100
JNJJohnson & JohnsonDiversified Pharma
talquetamab — multiple myeloma sNDA
C
60/100
REGNRegeneron PharmaceuticalsAntibody Therapeutics
dupixent — CSU additional indication
F
34/100
Not financial advice. BiotechSigns data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.