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Upcoming PDUFA Dates

FDA approval decision deadlines for biotech drugs

50 Active Signals
MRUSMerus NVBispecific Antibodies
zenocutuzumab — NRG1 fusion+ NSCLC/PDAC
A
90/100
RCKTRocket PharmaceuticalsGene Therapy
beremagene geperpavec — dystrophic epidermolysis bullosa
C
65/100
CLDXCelldex TherapeuticsImmuno-Oncology
barzolvolimab — chronic spontaneous urticaria
B
70/100
EXELExelixis IncOncology
zanzalintinib — renal cell carcinoma
B
68/100
NTLAIntellia TherapeuticsGene Editing
NTLA-2001 — ATTR cardiomyopathy
B
73/100
ASNDAscendis PharmaRare Endocrine
tolebrutinib — relapsing MS
B
71/100
SRPTSarepta TherapeuticsGene Therapy
elevidys (delandistrogene moxeparvovec) — DMD expanded sNDA
A
86/100
SAGESage TherapeuticsNeuroscience
SAGE-718 — Huntington's disease cognitive impairment
C
62/100
ARDXArdelyx IncNephrology
tenapanor — hyperphosphatemia in dialysis
B
69/100
AXSMAxsome TherapeuticsNeuroscience
AXS-05 — major depressive disorder adjunctive
C
62/100
MDGLMadrigal PharmaceuticalsLiver Disease
resmetirom — NASH/MASH pediatric sNDA
B
69/100
BMRNBioMarin PharmaceuticalRare Disease
BMN 307 — phenylketonuria
B
75/100
PTGXProtagonist TherapeuticsPeptide Therapeutics
setanaxib — idiopathic pulmonary fibrosis
C
52/100
AGENAgenus IncImmuno-Oncology
botensilimab + balstilimab — recurrent/metastatic cervical cancer
C
55/100
CYTKCytokinetics IncCardiovascular
aficamten — obstructive HCM sNDA
B
70/100
RAREUltragenyx PharmaceuticalRare Disease
setrusumab — osteogenesis imperfecta
C
57/100
DNLIDenali TherapeuticsNeuroscience
DNL343 — ALS
B
70/100
IOVAIovance BiotherapeuticsCell Therapy
lifileucel — melanoma sNDA broader indication
C
63/100
ARQTArcus BiosciencesImmuno-Oncology
roflumilast foam — seborrheic dermatitis
C
59/100
IMVTImmunovant IncAutoimmune
batoclimab — myasthenia gravis
C
64/100
SNDXSyndax PharmaceuticalsOncology
entinostat + exemestane — HR+ HER2- breast cancer
C
58/100
CRSPCRISPR TherapeuticsGene Editing
exagamglogene autotemcel — transfusion-dependent beta-thal
C
62/100
FOLDAmicus TherapeuticsRare Disease
pegunigalsidase alfa — Fabry disease pediatric
C
57/100
ITCIIntra-Cellular TherapiesNeuroscience
lumateperone — bipolar I maintenance
B
68/100
BNTXBioNTech SEmRNA Therapeutics
mRNA-4157 + pembrolizumab — adjuvant melanoma
C
53/100
REGNRegeneron PharmaceuticalsAntibody Therapeutics
dupixent (dupilumab) — chronic rhinosinusitis w/o polyps sNDA
D
39/100
BIIBBiogen IncNeuroscience
lecanemab (Leqembi) — early AD subcutaneous sNDA
C
53/100
TAKTakeda PharmaceuticalGI/Neuroscience
mezagitamab — IgA nephropathy
D
37/100
BLUEbluebird bioGene Therapy
lovo-cel — sickle cell disease sNDA
D
38/100
VERAVera TherapeuticsNephrology
atacicept — IgA nephropathy Phase 3
D
40/100
EDITEditas MedicineGene Editing
EDIT-301 — sickle cell disease
D
37/100
BMYBristol-Myers SquibbOncology
milvexian — stroke prevention/AF
D
41/100
FATEFate TherapeuticsCell Therapy
FT576 — multiple myeloma
F
34/100
APLSApellis PharmaceuticalsComplement Inhibitors
pegcetacoplan — geographic atrophy expanded
C
50/100
MIRMMirum PharmaceuticalsLiver Disease
maralixibat — biliary atresia pediatric
C
51/100
LLYEli Lilly and CompanyDiabetes/Oncology
orforglipron — obesity oral GLP-1
D
43/100
LLYEli Lilly and CompanyDiabetes/Oncology
retatrutide — obesity GLP-1/GIP/glucagon
D
43/100
JNJJohnson & JohnsonDiversified Pharma
nipocalimab — fetal/neonatal alloimmune thrombocytopenia
D
38/100
CGEMCullinan OncologyOncology
REC-994 — spinocerebellar ataxia type 3
F
31/100
PCVXVaxcyte IncVaccines
VAX-31 — pneumococcal 31-valent vaccine
D
50/100
NVSNovartis AGDiversified Pharma
remibrutinib — chronic spontaneous urticaria
C
52/100
JNJJohnson & JohnsonDiversified Pharma
talquetamab — multiple myeloma sNDA
D
38/100
REGNRegeneron PharmaceuticalsAntibody Therapeutics
dupixent — CSU additional indication
D
39/100
ALNYAlnylam PharmaceuticalsRNAi Therapeutics
ALN-AGT — resistant hypertension
C
53/100
MRNAModerna IncmRNA Therapeutics
mResvia (mRNA-1345) — RSV older adults sNDA
D
41/100
GILDGilead SciencesAntiviral
lenacapavir — HIV treatment once-weekly oral
D
43/100
BMYBristol-Myers SquibbOncology
relatlimab + nivolumab — adjuvant gastric cancer
D
41/100
PFEPfizer IncDiversified Pharma
danuglipron — obesity oral GLP-1
D
44/100
BMYBristol-Myers SquibbOncology
nivolumab (Opdivo) — neoadjuvant NSCLC sNDA
D
41/100
ALNYAlnylam PharmaceuticalsRNAi Therapeutics
inclisiran (LEQVIO) — cardiovascular sNDA
C
53/100
Not financial advice. BiotechSign 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.