LOGIN  |  REGISTER
Astria Therapeutics

Upcoming FDA Catalyst Calendar

  • May 25

    Abeona Therapeutics (NASDAQ: ABEO) PDUFA Date

    Saturday, May 25, 2024
    CompanyAbeona Therapeutics
    Stock QuoteNASDAQ: ABEO
    Study Namepz-cel
    Treatmentfor the treatment of patients with recessive dystrophic epidermolysis bullosa
    StatusBiologics License Applications (BLA)
    Catalyst DateMay 25, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • May 25

    Abeona Therapeutics (NASDAQ: ABEO) PDUFA Date

    Saturday, May 25, 2024
    CompanyAbeona Therapeutics
    Stock QuoteNASDAQ: ABEO
    Study Namepz-cel
    TreatmentPatients with recessive dystrophic epidermolysis bullosa
    StatusPhase 3
    Catalyst DateMay 25, 2024
    CatalystBiologics License Application (BLA)
    AnnouncementRead More
    WebsiteClick Here
  • Jun 4

    Catalyst Pharmaceuticals (NASDAQ: CPRX) PDUFA Date

    Tuesday, June 4, 2024
    CompanyCatalyst Pharmaceuticals
    Stock QuoteNASDAQ: CPRX
    Study NameFIRDAPSE®
    Treatmentfor the treatment of LEMS
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateJune 4, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jun 10

    Genfit (NASDAQ: GNFT) PDUFA Date

    Monday, June 10, 2024
    CompanyGenfit
    Stock QuoteNASDAQ: GNFT
    Study Nameelafibranor
    Treatmentfor the treatment of patients with the rare cholestatic liver disease
    StatusNew Drug Application (NDA)
    Catalyst DateJune 10, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jun 12

    Amgen (NASDAQ: AMGN) PDUFA Date

    Wednesday, June 12, 2024
    CompanyAmgen
    Stock QuoteNASDAQ: AMGN
    Study NameTarlatamab
    TreatmentSmall cell lung cancer (SCLC)
    StatusBiologics License Applications (BLA) Priority Review
    Catalyst DateJune 12, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jun 15

    Bristol-Myers Squibb (NYSE: BMY) PDUFA Date

    Saturday, June 15, 2024
    CompanyBristol-Myers Squibb
    Stock QuoteNYSE: BMY
    Study NameRepotrectinib
    TreatmentNTRK Fusion-Positive Advanced Solid Tumors
    StatusPhase 1/2
    Catalyst DateJune 15, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jun 17

    Merck (NYSE: MRK) PDUFA Date

    Monday, June 17, 2024
    CompanyMerck
    Stock QuoteNYSE: MRK
    Study NameKEYTRUDA®(pembrolizumab)
    Treatmentfor the treatment of patients with locally advanced or metastatic urothelial carcinoma
    Statussupplemental Biologics License Applications (sBLA)
    Catalyst DateJune 17, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jun 21

    Sarepta Therapeutics (NASDAQ: SRPT) PDUFA Date

    Friday, June 21, 2024
    CompanySarepta Therapeutics
    Stock QuoteNASDAQ: SRPT
    Study NameELEVIDYS (delandistrogene moxeparvovec-rokl)
    Treatmentdesigned to address the underlying cause of Duchenne muscular dystrophy through the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle.
    Statussupplemental Biologics License Applications (sBLA)
    Catalyst DateJune 21, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jun 26

    Verona Pharma (NASDAQ: VRNA) PDUFA Date

    Wednesday, June 26, 2024
    CompanyVerona Pharma
    Stock QuoteNASDAQ: VRNA
    Study NameEnsifentrine
    TreatmentChronic obstructive pulmonary disease (COPD)
    StatusNew Drug Application (NDA)
    Catalyst DateJune 26, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jul 7

    Arcutis Biotherapeutics (NASDAQ: ARQT) PDUFA Date

    Sunday, July 7, 2024
    CompanyArcutis Biotherapeutics
    Stock QuoteNASDAQ: ARQT
    Study NameRoflumilast Cream (ARQ-151 AD)
    TreatmentAtopic Dermatitis (AD)
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateJuly 7, 2024
    CatalystPDUFA Date
    AnnouncementRead More
    WebsiteClick Here
  • Jul 19

    Phathom Pharmaceuticals (NASDAQ: PHAT) PDUFA Date

    Friday, July 19, 2024
    CompanyPhathom Pharmaceuticals
    Stock QuoteNASDAQ: PHAT
    Study Namevonoprazan
    Treatmentfor the Treatment of Heartburn Associated with Non-Erosive GERD
    StatusNew Drug Application (NDA)
    Catalyst DateJuly 19, 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 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
  • 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
  • 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
  • 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

Sign Up To Get Daily Life Science Stock News

Please review our Disclaimer and Privacy Policy before subscribing.

Featured Stock

Compass Therapeutics

Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...

CLICK TO LEARN MORE

COPYRIGHT ©2023 HEALTH STOCKS HUB