Tuesday - July 8, 2025

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Upcoming FDA Catalyst Calendar

  • Jul 10

    Regeneron Pharmaceuticals (NASDAQ: REGN) PDUFA Date

    Thursday, July 10, 2025
    CompanyRegeneron Pharmaceuticals
    Stock QuoteNASDAQ: REGN
    Study NameLinvoseltamab (BCMAxCD3)
    TreatmentRelapsed/Refractory (R/R) Multiple Myeloma (MM)
    Statussupplemental Biologics License Applications (sBLA)
    Catalyst DateJuly 10, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jul 27

    Ascendis Pharma (NASDAQ: ASND) PDUFA Date

    Sunday, July 27, 2025
    CompanyAscendis Pharma
    Stock QuoteNASDAQ: ASND
    Study NameTransCon hGH (Lonapegsomatropin)
    TreatmentPediatric Growth Hormone Deficiency (GHD)
    Statussupplemental Biologics License Applications (sBLA)
    Catalyst DateJuly 27, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jul 28

    Apellis Pharmaceuticals (NASDAQ: APLS) PDUFA Date

    Monday, July 28, 2025
    CompanyApellis Pharmaceuticals
    Stock QuoteNASDAQ: APLS
    Study Namepegcetacoplan
    TreatmentParoxysmal nocturnal hemoglobinuria (PNH)
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateJuly 28, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jul 30

    Regeneron Pharmaceuticals (NASDAQ: REGN) PDUFA Date

    Wednesday, July 30, 2025
    CompanyRegeneron Pharmaceuticals
    Stock QuoteNASDAQ: REGN
    Study NameOdronextamab
    TreatmentTo treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL)
    StatusBiologics License Applications (BLA)
    Catalyst DateJuly 30, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 15

    Tonix Pharmaceuticals (NASDAQ: TNXP) PDUFA Date

    Friday, August 15, 2025
    CompanyTonix Pharmaceuticals
    Stock QuoteNASDAQ: TNXP
    Study NameTNX-102 SL
    TreatmentFibromyalgia
    StatusNew Drug Application (NDA)
    Catalyst DateAugust 15, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 18

    Ultragenyx Pharmaceutical (NASDAQ: RARE) PDUFA Date

    Monday, August 18, 2025
    CompanyUltragenyx Pharmaceutical
    Stock QuoteNASDAQ: RARE
    Study NameUX111
    TreatmentFor Sanfilippo syndrome type A (MPS IIIA)
    StatusBiologics License Applications (BLA)
    Catalyst DateAugust 18, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 19

    PTC Therapeutics (NASDAQ: PTCT) PDUFA Date

    Tuesday, August 19, 2025
    CompanyPTC Therapeutics
    Stock QuoteNASDAQ: PTCT
    Study NameVatiquinone (MOVE-FA)
    TreatmentFriedreich ataxia
    StatusNew Drug Application (NDA)
    Catalyst DateAugust 19, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 19

    Regeneron Pharmaceuticals (NASDAQ: REGN) PDUFA Date

    Tuesday, August 19, 2025
    CompanyRegeneron Pharmaceuticals
    Stock QuoteNASDAQ: REGN
    Study NameAflibercept
    TreatmentFor the treatment of patients with wet age-related macular degeneration (wAMD)
    Statussupplemental Biologics License Applications (sBLA) Priority Review
    Catalyst DateAugust 19, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 31

    Capricor Therapeutics (NASDAQ: CAPR) PDUFA Date

    Sunday, August 31, 2025
    CompanyCapricor Therapeutics
    Stock QuoteNASDAQ: CAPR
    Study Namederamiocel
    TreatmentFor the treatment of Duchenne muscular dystrophy (DMD)
    StatusBiologics License Applications (BLA)
    Catalyst DateAugust 31, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 31

    Capricor Therapeutics (NASDAQ: CAPR) PDUFA Date

    Sunday, August 31, 2025
    CompanyCapricor Therapeutics
    Stock QuoteNASDAQ: CAPR
    Study Namederamiocel
    TreatmentFor the treatment of Duchenne muscular dystrophy (DMD)
    StatusBiologics License Applications (BLA)
    Catalyst DateAugust 31, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 12

    BioCryst Pharmaceuticals (NASDAQ: BCRX) PDUFA Date

    Friday, September 12, 2025
    CompanyBioCryst Pharmaceuticals
    Stock QuoteNASDAQ: BCRX
    Study NameORLADEYO (berotralstat)
    TreatmentHereditary angioedema (HAE)
    StatusNew Drug Application (NDA)
    Catalyst DateSeptember 12, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 26

    Cytokinetics (NASDAQ: CYTK) PDUFA Date

    Friday, September 26, 2025
    CompanyCytokinetics
    Stock QuoteNASDAQ: CYTK
    Study NameAficamten
    TreatmentSymptomatic obstructive hypertrophic cardiomyopathy (oHCM)
    StatusPhase 3
    Catalyst DateSeptember 26, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 26

    Unicycive Therapeutics (NASDAQ: UNCY) PDUFA Date

    Friday, September 26, 2025
    CompanyUnicycive Therapeutics
    Stock QuoteNASDAQ: UNCY
    Study NameOxylanthanum Carbonate (OLC)
    TreatmentSymptomatic obstructive hypertrophic cardiomyopathy (oHCM)
    StatusPhase 1
    Catalyst DateJune 28, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Oct 7

    Jazz Pharmaceuticals (NASDAQ: JAZZ) PDUFA Date

    Tuesday, October 7, 2025
    CompanyJazz Pharmaceuticals
    Stock QuoteNASDAQ: JAZZ
    Study NameZepzelca (lurbinectedin)
    TreatmentRelapsed Small Cell Lung Cancer (SCLC)
    StatusPhase 3
    Catalyst DateOctober 7, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Oct 13

    Arcutis Biotherapeutics (NASDAQ: ARQT) PDUFA Date

    Monday, October 13, 2025
    CompanyArcutis Biotherapeutics
    Stock QuoteNASDAQ: ARQT
    Study NameZORYVE™ (roflumilast)
    TreatmentInhibitor of phosphodiesterase-4 (PDE4)
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateOctober 13, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Oct 25

    Syndax Pharmaceuticals (NASDAQ: SNDX) PDUFA Date

    Saturday, October 25, 2025
    CompanySyndax Pharmaceuticals
    Stock QuoteNASDAQ: SNDX
    Study NameRevumenib
    TreatmentRelapsed/Refractory KMT2Ar Acute Leukemia
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateOctober 25, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Oct 25

    Merck (NYSE: MRK) PDUFA Date

    Saturday, October 25, 2025
    CompanyMerck
    Stock QuoteNYSE: MRK
    Study Namesotatercept-csrk
    TreatmentIn adults with pulmonary arterial hypertension
    StatusBiologics License Applications (BLA) Priority Review
    Catalyst DateOctober 25, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Nov 9

    REGENXBIO (NASDAQ: RGNX) PDUFA Date

    Sunday, November 9, 2025
    CompanyREGENXBIO
    Stock QuoteNASDAQ: RGNX
    Study NameRGX-121
    TreatmentMPS II (Hunter Syndrome)
    StatusBiologics License Applications (BLA)
    Catalyst DateNovember 9, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Nov 30

    Ascendis Pharma (NASDAQ: ASND) PDUFA Date

    Sunday, November 30, 2025
    CompanyAscendis Pharma
    Stock QuoteNASDAQ: ASND
    Study NameTransCon CNP
    TreatmentIn Children with Achondroplasia
    StatusNew Drug Application (NDA)
    Catalyst DateNovember 30, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Nov 30

    Kura Oncology (NASDAQ: KURA) PDUFA Date

    Sunday, November 30, 2025
    CompanyKura Oncology
    Stock QuoteNASDAQ: KURA
    Study NameZiftomenib
    TreatmentTreatment of genetically defined AML patients with high unmet need
    StatusNew Drug Application (NDA)
    Catalyst DateNovember 30, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Dec 15

    Innoviva (NASDAQ: INVA) PDUFA Date

    Monday, December 15, 2025
    CompanyInnoviva
    Stock QuoteNASDAQ: INVA
    Study NameZoliflodacin
    TreatmentFor the Treatment of Uncomplicated Gonorrhea
    StatusPhase 3
    Catalyst DateDecember 15, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Dec 26

    Cytokinetics (NASDAQ: CYTK) PDUFA Date

    Friday, December 26, 2025
    CompanyCytokinetics
    Stock QuoteNASDAQ: CYTK
    Study NameAficamten
    TreatmentSymptomatic obstructive hypertrophic cardiomyopathy (oHCM)
    StatusNew Drug Application (NDA)
    Catalyst DateDecember 26, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jan 31

    Aquestive Therapeutics (NASDAQ: AQST) PDUFA Date

    Saturday, January 31, 2026
    CompanyAquestive Therapeutics
    Stock QuoteNASDAQ: AQST
    Study NameAnaphylm
    TreatmentFor epinephrine prodrug candidate product
    StatusNew Drug Application (NDA)
    Catalyst DateJanuary 31, 2026
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Feb 21

    Vanda Pharmaceuticals (NASDAQ: VNDA) PDUFA Date

    Saturday, February 21, 2026
    CompanyVanda Pharmaceuticals
    Stock QuoteNASDAQ: VNDA
    Study NameBysanti
    TreatmentFor the Treatments of Acute Bipolar I Disorder and Schizophrenia
    StatusNew Drug Application (NDA)
    Catalyst DateFebruary 21, 2026
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here

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