Cue Biopharma

Upcoming FDA Catalyst Calendar

  • Jun 5

    Merck (NYSE: MRK) PDUFA Date

    Monday, June 5, 2023
    CompanyMerck
    Stock QuoteNYSE: MRK
    Study NamePREVYMIS (letermovir)
    Treatmentnon-nucleoside CMV inhibitor
    Statussupplemental New Drug Application (sNDA) Priority Review
    Catalyst DateJune 5, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Jun 8

    4D Molecular Therapeutics (NASDAQ: FDMT) Data Presentation

    Thursday, June 8, 2023
    Company4D Molecular Therapeutics
    Stock QuoteNASDAQ: FDMT
    Study Name4D-710
    TreatmentCystic fibrosis lung disease
    StatusPhase 1/2
    Catalyst DateJune 8, 2023
    CatalystData Presentation
    Press ReleaseRead More
    WebsiteClick Here
  • Jun 15

    Albireo Pharma (NASDAQ: ALBO) PDUFA Date

    Thursday, June 15, 2023
    CompanyAlbireo Pharma
    Stock QuoteNASDAQ: ALBO
    Study NameBylvay (odevixibat)
    TreatmentProgressive Familial Intrahepatic Cholestasis (PFIC)
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateJune 15, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Jun 20

    argenx (NASDAQ: ARGX) PDUFA Date

    Tuesday, June 20, 2023
    Companyargenx
    Stock QuoteNASDAQ: ARGX
    Study NameEfgartigimod (ADAPT-SC)
    TreatmentGeneralized Myasthenia Gravis
    StatusPhase 3
    Catalyst DateJune 20, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Jun 21

    Aldeyra Therapeutics (NASDAQ: ALDX) PDUFA Date

    Wednesday, June 21, 2023
    CompanyAldeyra Therapeutics
    Stock QuoteNASDAQ: ALDX
    Study NameADX-2191
    TreatmentPrimary vitreoretinal lymphoma (PVRL)
    StatusNew Drug Application (NDA) Priority Review
    Catalyst DateJune 21, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Jun 22

    Intercept Pharmaceuticals (NASDAQ: ICPT) PDUFA Date

    Thursday, June 22, 2023
    CompanyIntercept Pharmaceuticals
    Stock QuoteNASDAQ: ICPT
    Study NameObeticholic Acid (OCA) and Bezafibrate (BZF)
    TreatmentPrimary Biliary Cholangitis (PBC)
    StatusPhase 3
    Catalyst DateJune 22, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Jun 22

    Sarepta Therapeutics (NASDAQ: SRPT) Data Presentation

    Thursday, June 22, 2023
    CompanySarepta Therapeutics
    Stock QuoteNASDAQ: SRPT
    Study NameSRP-9001
    TreatmentSRP-9001 (delandistrogene moxeparvovec)
    StatusBiologics License Applications (BLA)
    Catalyst DateJune 22, 2023
    CatalystData Presentation
    Press ReleaseRead More
    WebsiteClick Here
  • Jun 23

    Bristol-Myers Squibb (NYSE: BMY) PDUFA Date

    Friday, June 23, 2023
    CompanyBristol-Myers Squibb
    Stock QuoteNYSE: BMY
    Study NameMavacamten
    Treatmentsymptomatic obstructive hypertrophic cardiomyopathy (oHCM)
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateJune 23, 2023
    CatalystPDUFA Date
    WebsiteClick Here
  • Jun 28

    Bausch Health (NYSE: BHC) PDUFA Date

    Wednesday, June 28, 2023
    CompanyBausch Health
    Stock QuoteNYSE: BHC
    Study NameNOV03 (Perfluorohexyloctane)
    TreatmentDry Eye Disease Associated With Meibomian Gland Dysfunction PRN
    StatusPhase 3
    Catalyst DateJune 28, 2023
    CatalystPDUFA Date
    WebsiteClick Here
  • Jul 12

    BioCardia (NASDAQ: BCDA) Data Presentation

    Wednesday, July 12, 2023
    CompanyBioCardia
    Stock QuoteNASDAQ: BCDA
    Study NameCardiAMP
    TreatmentComprehensive biotherapeutic heart failure solution
    StatusData Safety and Monitoring Board (DSMB) Review
    Catalyst DateJuly 12, 2023
    CatalystData Presentation
    Press ReleaseRead More
    WebsiteClick Here
  • Jul 23

    Verrica Pharmaceuticals (NASDAQ: VRCA) PDUFA Date

    Sunday, July 23, 2023
    CompanyVerrica Pharmaceuticals
    Stock QuoteNASDAQ: VRCA
    Study NameVP-102
    Treatmentmolluscum contagiosum (molluscum)
    StatusNew Drug Application (NDA)
    Catalyst DateJuly 23, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Aug 5

    Biogen (NASDAQ: BIIB) PDUFA Date

    Saturday, August 5, 2023
    CompanyBiogen
    Stock QuoteNASDAQ: BIIB
    Study NameZuranolone
    TreatmentMajor depressive disorder (MDD) and Postpartum depression (PPD)
    StatusPhase 2
    Catalyst DateAugust 5, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Aug 20

    Neurocrine Biosciences (NASDAQ: NBIX) PDUFA Date

    Sunday, August 20, 2023
    CompanyNeurocrine Biosciences
    Stock QuoteNASDAQ: NBIX
    Study NameValbenazine (KINECT-HD)
    TreatmentChorea in Huntington Disease
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateAugust 20, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Aug 27

    SpringWorks Therapeutics (NASDAQ: SWTX) PDUFA Date

    Sunday, August 27, 2023
    CompanySpringWorks Therapeutics
    Stock QuoteNASDAQ: SWTX
    Study NameNirogacestat
    TreatmentOvarian Granulosa Cell Tumors
    StatusNew Drug Application (NDA) Priority Review
    Catalyst DateAugust 27, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Aug 27

    SpringWorks Therapeutics (NASDAQ: SWTX) PDUFA Date

    Sunday, August 27, 2023
    CompanySpringWorks Therapeutics
    Stock QuoteNASDAQ: SWTX
    Study NameNirogacestat (DeFi)
    TreatmentDesmoid tumors
    StatusNew Drug Application (NDA)
    Catalyst DateAugust 27, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Sep 28

    Ocuphire Pharma (NASDAQ: OCUP) PDUFA Date

    Thursday, September 28, 2023
    CompanyOcuphire Pharma
    Stock QuoteNASDAQ: OCUP
    Study NameNyxol
    Treatmentreversal of pharmacologically induced mydriasis (dilation of pupil for eye exams)
    StatusPhase 3
    Catalyst DateSeptember 28, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Oct 8

    Alnylam Pharmaceuticals (NASDAQ: ALNY) PDUFA Date

    Sunday, October 8, 2023
    CompanyAlnylam Pharmaceuticals
    Stock QuoteNASDAQ: ALNY
    Study NamePatisiran (APOLLO-B)
    TreatmentCardiomyopathy of both hereditary and wild-type ATTR amyloidosis
    Statussupplemental New Drug Application (sNDA)
    Catalyst DateOctober 8, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Oct 13

    Bristol-Myers Squibb (NYSE: BMY) PDUFA Date

    Friday, October 13, 2023
    CompanyBristol-Myers Squibb
    Stock QuoteNYSE: BMY
    Study NameOpdivo (nivolumab)
    Treatmentresected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
    Statussupplemental Biologics License Applications (sBLA)
    Catalyst DateOctober 13, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Oct 17

    Ardelyx (NASDAQ: ARDX) PDUFA Date

    Tuesday, October 17, 2023
    CompanyArdelyx
    Stock QuoteNASDAQ: ARDX
    Study Nametenapanor
    Treatmentcontrol of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
    StatusNew Drug Application (NDA)
    Catalyst DateOctober 17, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Oct 20

    Bausch Health (NYSE: BHC) PDUFA Date

    Friday, October 20, 2023
    CompanyBausch Health
    Stock QuoteNYSE: BHC
    Study NameIDP-126
    TreatmentAcne vulgaris in patients nine years of age and older
    StatusNew Drug Application (NDA)
    Catalyst DateOctober 20, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Oct 22

    Regeneron Pharmaceuticals (NASDAQ: REGN) PDUFA Date

    Sunday, October 22, 2023
    CompanyRegeneron Pharmaceuticals
    Stock QuoteNASDAQ: REGN
    Study NameDupixent (dupilumab)
    Treatmentmoderate-to-severe asthma
    Statussupplemental Biologics License Applications (sBLA) Priority Review
    Catalyst DateOctober 22, 2023
    CatalystPDUFA Date
    WebsiteClick Here
  • Nov 13

    Pacira BioSciences (NASDAQ: PCRX) PDUFA Date

    Monday, November 13, 2023
    CompanyPacira BioSciences
    Stock QuoteNASDAQ: PCRX
    Study NameEXPAREL (Bupivacaine Liposome Injectable Suspension)
    TreatmentPostsurgical Analgesia in Children
    StatusNew Drug Application (NDA)
    Catalyst DateNovember 13, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Nov 23

    Aldeyra Therapeutics (NASDAQ: ALDX) PDUFA Date

    Thursday, November 23, 2023
    CompanyAldeyra Therapeutics
    Stock QuoteNASDAQ: ALDX
    Study NameReproxalap
    TreatmentSmall-molecule modulator of RASP
    StatusNew Drug Application (NDA)
    Catalyst DateNovember 23, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Dec 22

    Ionis Pharmaceuticals (NASDAQ: IONS) PDUFA Date

    Friday, December 22, 2023
    CompanyIonis Pharmaceuticals
    Stock QuoteNASDAQ: IONS
    Study NameEplontersen (formerly AKCEA-TTR-L)
    TreatmentHereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN)
    StatusNew Drug Application (NDA) Priority Review
    Catalyst DateDecember 22, 2023
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Jan 3

    Checkpoint Therapeutics (NASDAQ: CKPT) PDUFA Date

    Wednesday, January 3, 2024
    CompanyCheckpoint Therapeutics
    Stock QuoteNASDAQ: CKPT
    Study NameCosibelimab (cSCC)
    TreatmentLocally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
    StatusBiologics License Applications (BLA)
    Catalyst DateJanuary 3, 2024
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here
  • Feb 26

    Minerva Neurosciences (NASDAQ: NERV) PDUFA Date

    Monday, February 26, 2024
    CompanyMinerva Neurosciences
    Stock QuoteNASDAQ: NERV
    Study NameRoluperidone (MIN-101)
    TreatmentSchizophrenia
    StatusNew Drug Application (NDA)
    Catalyst DateFebruary 26, 2024
    CatalystPDUFA Date
    Press ReleaseRead More
    WebsiteClick Here

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