ORION Biotech Catalyst Calendar
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Each date comes with the SEC sentence it came from. Open a line to see the sentence and how its wording has changed.Each date comes with its SEC sentence.

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Dates the companies stated

  1. IONSIonis Pharmaceuticals · bepirovirsen · chronic hepatitis BPDUFA target date (company stated) MatchedSEC ↗Watch

    7 days left

    PDUFA target action date of October 26, 2026Details

    IONIS PHARMACEUTICALS INC (IONS) · bepirovirsen · chronic hepatitis B

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $5.2B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    PDUFA target action date of October 26, 2026

    SEC Form filing · Filed: · Accession: 0001140361-26-029960 · Last checked: · Matched

    Earlier SEC statements (3)
    1. · “PDUFA action date of October 26, 2026” · SEC filing
    2. · “PDUFA action date of October 26, 2026” · SEC filing
    3. · “PDUFA date of October 26, 2026” · SEC filing
  2. INOInovio Pharmaceuticals · INO-3107PDUFA target date (company stated) MatchedSEC ↗Watch

    11 days left

    (PDUFA) target date for October 30, 2026.Details

    INOVIO PHARMACEUTICALS, INC. (INO) · INO-3107

    Stage: PDUFASEC filing · “PDUFA) target date”

    Public float (as of ): $74M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026.

    SEC Form 10-Q · Filed: · Accession: 0001055726-26-000023 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “In December 2025, the FDA accepted for review the company’s BLA for INO-3107 under the accelerated approval program and set a target PDUFA date for October 30, 2026.” · SEC filing
    2. · “In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026.” · SEC filing
  3. AGIOAgios Pharmaceuticals · mitapivatPDUFA target date (company stated) MatchedSEC ↗Watch

    13 days left

    approval pathway, is November 1, 2026.Details

    AGIOS PHARMACEUTICALS, INC. (AGIO) · mitapivat

    Stage: PDUFASEC filing · “PDUFA) goal date”

    Public float (as of ): $1.9B (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026.

    SEC Form 8-K · Filed: · Accession: 0001439222-26-000115 · Last checked: · Matched

  4. ICCCImmuCell · Unaudited financial results for the quarter and nine months ended September 30, 2026Financial results MatchedSEC ↗Watch

    25 days left

    conference call on Friday, November 13, 2026, at 9:00 AM ET to discuss the unaudited financialDetails

    IMMUCELL CORP /DE/ (ICCC) · Unaudited financial results for the quarter and nine months ended September 30, 2026

    Stage: Not stated

    Public float (as of ): $50M (SEC filing) · Under $500M

    Date the company stated:

    The Company is planning to host a conference call on Friday, November 13, 2026, at 9:00 AM ET to discuss the unaudited financial results for the quarter and nine months ended September 30, 2026.

    SEC Form 8-K · Filed: · Accession: 0001437749-26-032465 · Last checked: · Matched

  5. CYTKCytokinetics · aficamtenPDUFA target date (company stated) MatchedSEC ↗Watch

    26 days left

    sNDA with a PDUFA date of November 14, 2026.Details

    CYTOKINETICS INC (CYTK) · aficamten

    Stage: PDUFASEC filing · “PDUFA date”

    Public float (as of ): $2.5B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-338217 · Last checked: · Matched

  6. NTHINeOnc Technologies Holdings · NEO212FDA meeting Meeting date, not a results announcement MatchedSEC ↗Watch

    29 days left

    and Drug Administration on November 17, 2026, for an in-person End-of-Phase 1 Type B meetingDetails

    NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI) · NEO212

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $67M (SEC filing) · Under $500M

    Date the company stated:

    On September 28, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that it is scheduled to meet with the U.S. Food and Drug Administration on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212.

    SEC Form 8-K · Filed: · Accession: 0001829126-26-010493 · Last checked: · Matched

  7. SVRASavara · molgramostimPDUFA target date (company stated) MatchedSEC ↗Watch

    34 days left

    target action date to November 22, 2026.Details

    Savara Inc (SVRA) · molgramostim

    Stage: PDUFASEC filing · “PDUFA") target action date”

    Public float (as of ): $544M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-344585 · Last checked: · Matched

  8. COGTCogent Biosciences · bezuclastinib and sunitinib · GIST after prior imatinibPDUFA target date (company stated) MatchedSEC ↗Watch

    42 days left

    PDUFA target action date of November 30, 2026Details

    Cogent Biosciences, Inc. (COGT) · bezuclastinib and sunitinib · GIST after prior imatinib

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $772M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    PDUFA target action date of November 30, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-342393 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “PDUFA date of November 30, 2026” · SEC filing
  9. VRTXVertex Pharmaceuticals · povetacicept · IgA nephropathy in adultsPDUFA target date (company stated) MatchedSEC ↗Watch

    42 days left

    PDUFA target action date of November 30, 2026Details

    VERTEX PHARMACEUTICALS INC / MA (VRTX) · povetacicept · IgA nephropathy in adults

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $113.4B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    PDUFA target action date of November 30, 2026

    SEC Form filing · Filed: · Accession: 0000875320-26-000259 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “PDUFA target action date of November 30, 2026” · SEC filing
  10. EXELExelixis · zanzalintinib and atezolizumab · previously treated metastatic colorectal cancerPDUFA target date (company stated) MatchedSEC ↗Watch

    45 days left

    target action date of December 3, 2026Details

    EXELIXIS, INC. (EXEL) · zanzalintinib and atezolizumab · previously treated metastatic colorectal cancer

    Stage: PDUFASEC filing · “PDUFA) target action date”

    Public float (as of ): $9.4B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026

    SEC Form filing · Filed: · Accession: 0000939767-26-000098 · Last checked: · Matched

    Earlier SEC statements (6)
    1. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
    2. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
    3. · “PDUFA target action date of December 3, 2026” · SEC filing
    4. · “target action date of December 3, 2026” · SEC filing
    5. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
    6. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
  11. ANABAnaptysBio · imsidolimab · generalized pustular psoriasisPDUFA target date (company stated) MatchedSEC ↗Watch

    54 days left

    target action date of December 12, 2026Details

    ANAPTYSBIO, INC (ANAB) · imsidolimab · generalized pustular psoriasis

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $432M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    target action date of December 12, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-219515 · Last checked: · Matched

    Earlier SEC statements (3)
    1. · “target action date (PDUFA) of Dec. 12, 2026” · SEC filing
    2. · “target action date of December 12, 2026” · SEC filing
    3. · “target action date of Dec. 12, 2026” · SEC filing
  12. MLYSMineralys Therapeutics · lorundrostatPDUFA target date (company stated) MatchedSEC ↗Watch

    64 days left

    Act (PDUFA) target date of December 22, 2026 for lorundrostat.Details

    Mineralys Therapeutics, Inc. (MLYS) · lorundrostat

    Stage: PDUFASEC filing · “PDUFA) target date”

    Public float (as of ): $676M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.

    SEC Form 10-Q · Filed: · Accession: 0001933414-26-000114 · Last checked: · Matched

    Earlier SEC statements (6)
    1. · “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.” · SEC filing
    2. · “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target date of December 22, 2026 for lorundrostat.” · SEC filing
    3. · “Food and Drug Administration (FDA) accepted the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.” · SEC filing
    4. · “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.” · SEC filing
    5. · “The FDA accepted the NDA submission and provided us with a PDUFA target action date of December 22, 2026.” · SEC filing
    6. · “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target action date of December 22, 2026.” · SEC filing
  13. GILDGilead Sciences · anito-cel · relapsed or refractory multiple myeloma after at least three prior therapiesPDUFA target date (company stated) MatchedSEC ↗Watch

    65 days left

    PDUFA target action date of December 23, 2026Details

    GILEAD SCIENCES, INC. (GILD) · anito-cel · relapsed or refractory multiple myeloma after at least three prior therapies

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $103.2B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    PDUFA target action date of December 23, 2026

    SEC Form filing · Filed: · Accession: 0000882095-26-000031 · Last checked: · Matched

    Earlier SEC statements (3)
    1. · “PDUFA target action date of December 23, 2026” · SEC filing
    2. · “PDUFA target action date of December 23, 2026” · SEC filing
    3. · “Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026” · SEC filing
  14. PRAXPraxis Precision Medicines · relutrigine · SCN2A and SCN8A developmental and epileptic encephalopathiesPDUFA target date (company stated) MatchedSEC ↗Watch

    69 days left

    PDUFA target action date of December 27, 2026Details

    Praxis Precision Medicines, Inc. (PRAX) · relutrigine · SCN2A and SCN8A developmental and epileptic encephalopathies

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $883M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    PDUFA target action date of December 27, 2026

    SEC Form filing · Filed: · Accession: 0001689548-26-000082 · Last checked: · Matched

    Earlier SEC statements (7)
    1. · “PDUFA action date of September 27, 2026” · SEC filing
    2. · “PDUFA action date of December 27, 2026” · SEC filing
    3. · “PDUFA date of December 27, 2026” · SEC filing
    4. · “PDUFA target action date from September 27, 2026” · SEC filing
    5. · “PDUFA target action date of September 27, 2026” · SEC filing
    6. · “PDUFA action date of September 27, 2026” · SEC filing
    7. · “target action date under the Prescription Drug User Fee Act of September 27, 2026” · SEC filing
  15. COGTCogent Biosciences · bezuclastinib · nonadvanced systemic mastocytosisPDUFA target date (company stated) MatchedSEC ↗Watch

    72 days left

    target action date of December 30, 2026Details

    Cogent Biosciences, Inc. (COGT) · bezuclastinib · nonadvanced systemic mastocytosis

    Stage: PDUFASEC filing · “PDUFA") target action date”

    Public float (as of ): $772M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-342393 · Last checked: · Matched

    Earlier SEC statements (3)
    1. · “PDUFA date of December 30, 2026” · SEC filing
    2. · “Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026” · SEC filing
    3. · “Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026” · SEC filing
  16. NUVBNuvation Bio · taletrectinib / IBTROZIPDUFA target date (company stated) MatchedSEC ↗Watch

    77 days left

    a target action date of January 4, 2027.Details

    Nuvation Bio Inc. (NUVB) · taletrectinib / IBTROZI

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $496M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027.

    ClinicalTrials.gov NCT04395677 · NCT stated in SEC filing

    ClinicalTrials.gov NCT04919811 · NCT stated in SEC filing

    SEC Form 8-K · Filed: · Accession: 0001193125-26-336751 · Last checked: · Matched

  17. DYNDyne Therapeutics · zeleciment rostudirsen (DYNE-251) · Duchenne muscular dystrophy amenable to exon 51 skippingPDUFA target date (company stated) MatchedSEC ↗Watch

    94 days left

    target action date set for January 21, 2027Details

    Dyne Therapeutics, Inc. (DYN) · zeleciment rostudirsen (DYNE-251) · Duchenne muscular dystrophy amenable to exon 51 skipping

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $948M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    PDUFA target action date set for January 21, 2027

    SEC Form filing · Filed: · Accession: 0001193125-26-323940 · Last checked: · Matched

    Earlier SEC statements (3)
    1. · “Prescription Drug User Fee Act (PDUFA) target action date set for January 21, 2027” · SEC filing
    2. · “Prescription Drug User Fee Act, or PDUFA, target action date of January 21, 2027” · SEC filing
    3. · “Prescription Drug User Fee Act target action date of January 21, 2027” · SEC filing
  18. PRAXPraxis Precision Medicines · ulixacaltamide · essential tremorPDUFA target date (company stated) MatchedSEC ↗Watch

    102 days left

    User Fee Act, or PDUFA, of January 29, 2027Details

    Praxis Precision Medicines, Inc. (PRAX) · ulixacaltamide · essential tremor

    Stage: PDUFASEC filing · “target action date under the Prescription Drug User Fee Act, or PDUFA”

    Public float (as of ): $883M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027

    SEC Form filing · Filed: · Accession: 0001689548-26-000083 · Last checked: · Matched

    Earlier SEC statements (5)
    1. · “PDUFA date of January 29, 2027” · SEC filing
    2. · “target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027” · SEC filing
    3. · “PDUFA target action date of January 29, 2027” · SEC filing
    4. · “target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027” · SEC filing
    5. · “target action date under the Prescription Drug User Fee Act of January 29, 2027” · SEC filing
  19. GILDGilead Sciences · lenacapavir oral 300-mg · HIV pre-exposure prophylaxisPDUFA target date (company stated) MatchedSEC ↗Watch

    106 days left

    target action date of February 2, 2027Details

    GILEAD SCIENCES, INC. (GILD) · lenacapavir oral 300-mg · HIV pre-exposure prophylaxis

    Stage: PDUFASEC filing · “PDUFA”) target action date”

    Public float (as of ): $103.2B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (“PDUFA”) target action date of February 2, 2027

    SEC Form filing · Filed: · Accession: 0000882095-26-000031 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “Prescription Drug User Fee Act target action date of February 2, 2027” · SEC filing
  20. ARQTArcutis Biotherapeutics · roflumilast cream 0.05%PDUFA target date (company stated) MatchedSEC ↗Watch

    127 days left

    set target action date of February 23, 2027Details

    Arcutis Biotherapeutics, Inc. (ARQT) · roflumilast cream 0.05%

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $1.5B (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    FDA accepted sNDA for ZORYVE cream 0.05% to expand indication to include infants with mild to moderate atopic dermatitis aged 3 to 24 months and set target action date of February 23, 2027

    SEC Form 8-K · Filed: · Accession: 0001787306-26-000049 · Last checked: · Matched

  21. CGEMCullinan Therapeutics · zipalertinibPDUFA target date (company stated) MatchedSEC ↗Watch

    131 days left

    target action date of February 27, 2027.Details

    Cullinan Therapeutics, Inc. (CGEM) · zipalertinib

    Stage: PDUFASEC filing · “PDUFA) target action date”

    Public float (as of ): $442M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.

    SEC Form 8-K · Filed: · Accession: 0001193125-26-411011 · Last checked: · Matched

    Earlier SEC statements (4)
    1. · “FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027.” · SEC filing
    2. · “The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.” · SEC filing
    3. · “The Prescription Drug User Fee Act target action date is February 27, 2027.” · SEC filing
    4. · “The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.” · SEC filing
  22. BMRNBiomarin Pharmaceutical · vosoritide · children with achondroplasia; full approval applicationPDUFA target date (company stated) MatchedSEC ↗Watch

    132 days left

    target action date of February 28, 2027Details

    BIOMARIN PHARMACEUTICAL INC (BMRN) · vosoritide · children with achondroplasia; full approval application

    Stage: PDUFASEC filing · “PDUFA) target action date”

    Public float (as of ): $6.7B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027

    SEC Form filing · Filed: · Accession: 0001048477-26-000016 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027” · SEC filing
  23. NTLAIntellia Therapeutics · lonvoguran ziclumeran · hereditary angioedemaPDUFA target date (company stated) MatchedSEC ↗Watch

    142 days left

    PDUFA target action date of March 10, 2027Details

    Intellia Therapeutics, Inc. (NTLA) · lonvoguran ziclumeran · hereditary angioedema

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $869M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    PDUFA target action date of March 10, 2027

    SEC Form filing · Filed: · Accession: 0001193125-26-385194 · Last checked: · Matched

    Earlier SEC statements (4)
    1. · “Prescription Drug User Fee Act (PDUFA) date of March 10, 2027” · SEC filing
    2. · “Prescription Drug User Fee Act ("PDUFA") target action date of March 10, 2027” · SEC filing
    3. · “Prescription Drug User Fee Act (“PDUFA”) target action date of March 10, 2027” · SEC filing
    4. · “PDUFA target action date of March 10, 2027” · SEC filing
  24. INBXInhibrx Biosciences · ozekibartPDUFA target date (company stated) MatchedSEC ↗Watch

    177 days left

    Act (PDUFA) goal date of April 14, 2027.Details

    Inhibrx Biosciences, Inc. (INBX) · ozekibart

    Stage: PDUFASEC filing · “PDUFA) goal date”

    Public float (as of ): $174M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    biologics license application (BLA) for the potential approval of ozekibart in conventional chondrosarcoma and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027.

    SEC Form 8-K · Filed: · Accession: 0002007919-26-000044 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “The FDA has not identified any filing review issues at this time and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027.” · SEC filing
    2. · “The FDA has not identified any filing review issues at this time and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027.” · SEC filing
  25. IMNMImmunome · varegacestat · desmoid tumors in adultsPDUFA target date (company stated) MatchedSEC ↗Watch

    191 days left

    target action date of April 28, 2027Details

    Immunome Inc. (IMNM) · varegacestat · desmoid tumors in adults

    Stage: PDUFASEC filing · “PDUFA, target action date”

    Public float (as of ): $728M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act, or PDUFA, target action date of April 28, 2027

    SEC Form filing · Filed: · Accession: 0001193125-26-344636 · Last checked: · Matched

    Earlier SEC statements (4)
    1. · “PDUFA target action date of April 28, 2027” · SEC filing
    2. · “PDUFA date of April 28, 2027” · SEC filing
    3. · “PDUFA target action date set for April 28, 2027” · SEC filing
    4. · “PDUFA target action date of April 28, 2027” · SEC filing
  26. AXSMAxsome Therapeutics · AXS-12 (reboxetine) · cataplexy in narcolepsyPDUFA target date (company stated) MatchedSEC ↗Watch

    194 days left

    target action date of May 1, 2027Details

    Axsome Therapeutics, Inc. (AXSM) · AXS-12 (reboxetine) · cataplexy in narcolepsy

    Stage: PDUFASEC filing · “PDUFA) target action date”

    Public float (as of ): $4.4B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027

    SEC Form filing · Filed: · Accession: 0001193125-26-342360 · Last checked: · Matched

    Earlier SEC statements (4)
    1. · “PDUFA target action date of May 1, 2027” · SEC filing
    2. · “PDUFA target action (May 1, 2027” · SEC filing
    3. · “Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027” · SEC filing
    4. · “PDUFA target action date of May 1, 2027” · SEC filing
  27. ZBIOZenas BioPharma · obexelimabPDUFA target date (company stated) MatchedSEC ↗Watch

    220 days left

    target action date of May 27, 2027.Details

    Zenas BioPharma, Inc. (ZBIO) · obexelimab

    Stage: PDUFASEC filing · “PDUFA) target action date”

    Public float (as of ): $259M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027.

    ClinicalTrials.gov NCT05662241 · NCT stated in SEC filing

    SEC Form 8-K · Filed: · Accession: 0001104659-26-095437 · Last checked: · Matched

Months the companies stated

  1. STTKShattuck Labs · SL-846Topline/data readout MatchedSEC ↗Watch

    1 day left

    at UEG Week, to be held October 17-20, 2026.Details

    Shattuck Labs, Inc. (STTK) · SL-846

    Stage: OtherSEC filing · “Preclinical”

    Public float (as of ): $22M (SEC filing) · Under $500M

    Month the company stated:

    Preclinical data for SL-846, including safety, pharmacokinetics, and receptor occupancy from the ongoing GLP toxicology study are expected to be presented in a poster at UEG Week, to be held October 17-20, 2026.

    SEC Form 8-K · Filed: · Accession: 0001628280-26-055484 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “Safety and immunogenicity data are expected in the second half of 2026.” · SEC filing
  2. IOVAIovance Biotherapeutics · lifileucelTopline/data readout MatchedSEC ↗Watch

    8 days left

    in Madrid, Spain, from October 23–27, 2026.Details

    IOVANCE BIOTHERAPEUTICS, INC. (IOVA) · lifileucel

    Stage: Not stated

    Public float (as of ): $534M (SEC filing) · $500M–$2B

    Month the company stated:

    Results will be highlighted in an oral presentation (abstract #3725RO) at the European Society for Medical Oncology (ESMO) meeting in Madrid, Spain, from October 23–27, 2026.

    SEC Form 8-K · Filed: · Accession: 0001104659-26-091619 · Last checked: · Matched

  3. TNGXTango Therapeutics · vopimetostat + RAS(ON) inhibitorsTopline/data readout MatchedSEC ↗Watch

    8 days left

    in Madrid, Spain from October 23-27, 2026.Details

    Tango Therapeutics, Inc. (TNGX) · vopimetostat + RAS(ON) inhibitors

    Stage: OtherSEC filing · “Phase 1/2”

    Public float (as of ): $528M (SEC filing) · $500M–$2B

    Month the company stated:

    We plan to share data from the Phase 1/2 trial of the combination of vopimetostat plus RAS(ON) inhibitors at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain from October 23-27, 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-343424 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “Present 2/3L PDAC vopimetostat + RAS(ON) inhibitors combination data at a scientific conference 2H 2026” · SEC filing
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FDA dates and trial readouts as each company stated them, with SEC original links. 250 programs as of . Free, with no sign-in. No forecasts, prices or signals.

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A PDUFA date is the target date by which the FDA aims to decide on a drug or biologic application.A Form 10-K is a company’s annual report to the SEC, with audited financial statements.