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Upcoming FDA Catalyst Calendar

  • Aug 4

    Adaptimmune Therapeutics (NASDAQ: ADAP) PDUFA Date

    Sunday, August 4, 2024
    CompanyAdaptimmune Therapeutics
    Stock QuoteNASDAQ: ADAP
    Study NameAfami-cel
    Treatmentadvanced synovial sarcoma
    StatusBiologics License Application (BLA)
    Catalyst DateAugust 4, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 10

    Humacyte (NASDAQ: HUMA) PDUFA Date

    Saturday, August 10, 2024
    CompanyHumacyte
    Stock QuoteNASDAQ: HUMA
    Study NameHuman Acellular Vessel
    TreatmentCoronary Artery Bypass Grafting
    StatusBiologics License Applications (BLA) Priority Review
    Catalyst DateAugust 10, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 13

    Citius Pharmaceuticals (NASDAQ: CTXR) PDUFA Date

    Tuesday, August 13, 2024
    CompanyCitius Pharmaceuticals
    Stock QuoteNASDAQ: CTXR
    Study NameLYMPHIR
    TreatmentTreatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
    StatusBiologics License Application (BLA)
    Catalyst DateAugust 13, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 14

    CymaBay Therapeutics (NASDAQ: CBAY) PDUFA Date

    Wednesday, August 14, 2024
    CompanyCymaBay Therapeutics
    Stock QuoteNASDAQ: CBAY
    Study Nameseladelpar
    Treatmentfor the Treatment of Primary Biliary Cholangitis Including Pruritus
    StatusNew Drug Application (NDA)
    Catalyst DateAugust 14, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 14

    Ascendis Pharma (NASDAQ: ASND) PDUFA Date

    Wednesday, August 14, 2024
    CompanyAscendis Pharma
    Stock QuoteNASDAQ: ASND
    Study NameTransCon PTH
    TreatmentAdult Hypoparathyroidism
    StatusNew Drug Application (NDA)
    Catalyst DateAugust 14, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 28

    Applied Therapeutics (NASDAQ: APLT) PDUFA Date

    Wednesday, August 28, 2024
    CompanyApplied Therapeutics
    Stock QuoteNASDAQ: APLT
    Study NameAT-007
    TreatmentGalactosemia
    StatusNew Drug Application (NDA)
    Catalyst DateAugust 28, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Aug 28

    Syndax Pharmaceuticals (NASDAQ: SNDX) PDUFA Date

    Wednesday, August 28, 2024
    CompanySyndax Pharmaceuticals
    Stock QuoteNASDAQ: SNDX
    Study NameAxatilimab
    TreatmentChronic Graft Versus Host Disease (cGVHD)
    StatusBiologics License Applications (BLA) Priority Review
    Catalyst DateAugust 28, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 5

    Travere Therapeutics (NASDAQ: TVTX) PDUFA Date

    Thursday, September 5, 2024
    CompanyTravere Therapeutics
    Stock QuoteNASDAQ: TVTX
    Study NameFILSPARI
    Treatmentendothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateSeptember 5, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 7

    Avadel Pharmaceuticals (NASDAQ: AVDL) PDUFA Date

    Saturday, September 7, 2024
    CompanyAvadel Pharmaceuticals
    Stock QuoteNASDAQ: AVDL
    Study NameLUMRYZ (sodium oxybate)
    Treatmentextended-release sodium oxybate medication
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateSeptember 7, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 9

    Iterum Therapeutics (NASDAQ: ITRM) FDA Meeting

    Monday, September 9, 2024
    CompanyIterum Therapeutics
    Stock QuoteNASDAQ: ITRM
    Study Namesulopenem etzadroxil/probenecid
    TreatmentUncomplicated urinary tract infections (uUTIs)
    StatusPhase 3
    Catalyst DateSeptember 9, 2024
    CatalystFDA Meeting
    AnnouncementRead More
    WebsiteClick Here
  • Sep 23

    Heron Therapeutics (NASDAQ: HRTX) PDUFA Date

    Monday, September 23, 2024
    CompanyHeron Therapeutics
    Stock QuoteNASDAQ: HRTX
    Study NameZYNRELEF (bupivacaine and meloxicam HTX-011)
    TreatmentPostoperative pain
    StatusPhase 3
    Catalyst DateSeptember 23, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 25

    Merck (NYSE: MRK) PDUFA Date

    Wednesday, September 25, 2024
    CompanyMerck
    Stock QuoteNYSE: MRK
    Study NameKEYNOTE-483
    Treatmentfor the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
    Statussupplemental Biologics License Applications (sBLA) Priority Review
    Catalyst DateSeptember 25, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 26

    Karuna Therapeutics (NASDAQ: KRTX) PDUFA Date

    Thursday, September 26, 2024
    CompanyKaruna Therapeutics
    Stock QuoteNASDAQ: KRTX
    Study NameKarXT (xanomeline-trospium)
    TreatmentHealthy Elderly Volunteers
    StatusNew Drug Application (NDA)
    Catalyst DateSeptember 26, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 27

    Sanofi (NASDAQ: SNY) PDUFA Date

    Friday, September 27, 2024
    CompanySanofi
    Stock QuoteNASDAQ: SNY
    Study NameDupixent (dupilumab)
    Treatmentmoderate-to-severe asthma
    Statussupplemental Biologics License Applications (sBLA)
    Catalyst DateSeptember 27, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Sep 27

    Sanofi (NASDAQ: SNY) PDUFA Date

    Friday, September 27, 2024
    CompanySanofi
    Stock QuoteNASDAQ: SNY
    Study Nameisatuximab
    TreatmentTransplant-ineligible newly diagnosed multiple myeloma (NDMM).
    Statussupplemental Biologics License Applications (sBLA) Priority Review
    Catalyst DateSeptember 27, 2024
    CatalystPDUFA Date
    AnnouncementN/A
    WebsiteClick Here
  • Oct 1

    NeuroOne Medical Technologies (NASDAQ: NMTC) Data Presentation

    Tuesday, October 1, 2024
    CompanyNeuroOne Medical Technologies
    Stock QuoteNASDAQ: NMTC
    Study NameICD-10
    TreatmentsEEG RF Ablation
    StatusN/A
    Catalyst DateOctober 1, 2024
    CatalystData Presentation
    AnnouncementRead More
    WebsiteClick Here
  • Nov 13

    PTC Therapeutics (NASDAQ: PTCT) PDUFA Date

    Wednesday, November 13, 2024
    CompanyPTC Therapeutics
    Stock QuoteNASDAQ: PTCT
    Study NameUpstaza
    TreatmentAromatic L-amino acid decarboxylase (AADC) deficiency
    StatusBiologics License Applications (BLA)
    Catalyst DateNovember 13, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Nov 16

    Autolus Therapeutics (NASDAQ: AUTL) PDUFA Date

    Saturday, November 16, 2024
    CompanyAutolus Therapeutics
    Stock QuoteNASDAQ: AUTL
    Study NameObe-cel (AUTO1 - ALLCAR19) ALL
    TreatmentAdult Acute lymphoblastic leukemia (ALL)
    Status N/A
    Catalyst DateNovember 16, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Nov 28

    Applied Therapeutics (NASDAQ: APLT) PDUFA Date

    Thursday, November 28, 2024
    CompanyApplied Therapeutics
    Stock QuoteNASDAQ: APLT
    Study NameAT-007
    TreatmentGalactosemia
    StatusNew Drug Application (NDA)
    Catalyst DateNovember 28, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Nov 29

    BridgeBio Pharma (NASDAQ: BBIO) PDUFA Date

    Friday, November 29, 2024
    CompanyBridgeBio Pharma
    Stock QuoteNASDAQ: BBIO
    Study NameAcoramidis (ATTRibute-CM)
    TreatmentSymptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM)
    StatusNew Drug Application (NDA)
    Catalyst DateNovember 29, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Nov 29

    Jazz Pharmaceuticals (NASDAQ: JAZZ) PDUFA Date

    Friday, November 29, 2024
    CompanyJazz Pharmaceuticals
    Stock QuoteNASDAQ: JAZZ
    Study NameZanidatamab
    TreatmentIn HER2+/HR+ Metastatic Breast Cancer
    StatusBiologics License Applications (BLA) Priority Review
    Catalyst DateNovember 29, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Dec 20

    AstraZeneca (NASDAQ: AZN) PDUFA Date

    Friday, December 20, 2024
    CompanyAstraZeneca
    Stock QuoteNASDAQ: AZN
    Study NameDatopotamab deruxtecan (Dato-DXd)
    TreatmentHormone Receptor Positive
    StatusBiologics License Applications (BLA)
    Catalyst DateDecember 20, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Dec 28

    Checkpoint Therapeutics (NASDAQ: CKPT) PDUFA Date

    Saturday, December 28, 2024
    CompanyCheckpoint Therapeutics
    Stock QuoteNASDAQ: CKPT
    Study NameCosibelimab (cSCC)
    TreatmentLocally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
    StatusBiologics License Applications (BLA)
    Catalyst DateDecember 28, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Dec 30

    Neurocrine Biosciences (NASDAQ: NBIX) PDUFA Date

    Monday, December 30, 2024
    CompanyNeurocrine Biosciences
    Stock QuoteNASDAQ: NBIX
    Study Namecrinecerfont
    TreatmentFor the Treatment of Congenital Adrenal Hyperplasia (CAH)
    StatusNew Drug Application (NDA)
    Catalyst DateDecember 30, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Feb 28

    Bristol-Myers Squibb (NYSE: BMY) PDUFA Date

    Friday, February 28, 2025
    CompanyBristol-Myers Squibb
    Stock QuoteNYSE: BMY
    Study NameOpdivo (nivolumab)
    Treatmentresected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
    StatusPhase 3
    Catalyst DateFebruary 28, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Feb 28

    Eton Pharmaceuticals (NASDAQ: ETON) PDUFA Date

    Friday, February 28, 2025
    CompanyEton Pharmaceuticals
    Stock QuoteNASDAQ: ETON
    Study NameET-400
    TreatmentHydrocortisone Oral Solution
    StatusNew Drug Application (NDA)
    Catalyst DateFebruary 28, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Mar 6

    scPharmaceuticals (NASDAQ: SCPH) PDUFA Date

    Thursday, March 6, 2025
    CompanyscPharmaceuticals
    Stock QuoteNASDAQ: SCPH
    Study NameFUROSCIX
    TreatmentDecompensated heart failure
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateMarch 6, 2025
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here

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