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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. INOInovio Pharmaceuticals · INO-3107PDUFA target date (company stated) Quote matches the filingSEC ↗

    0 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: · Quote matches the filing

    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
  2. AGIOAgios Pharmaceuticals · mitapivatPDUFA target date (company stated) Quote matches the filingSEC ↗

    2 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: · Quote matches the filing

  3. NRXPNRX Pharmaceuticals · KETAFREE (preservative-free ketamine) · not stated in the cited filingGDUFA goal date (company stated) Quote matches the filingSEC ↗

    11 days left

    the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will notDetails

    NRX Pharmaceuticals, Inc. (NRXP) · KETAFREE (preservative-free ketamine) · not stated in the cited filing

    Stage: Not stated

    Public float: Unknown (no public float found in SEC filings)

    GDUFA goal date (company stated):

    The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.

    SEC Form 8-K · Filed: · Accession: 0001437749-26-030492 · Last checked: · Quote matches the filing

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “The KETAFREE™ ANDA was refiled in September 2025, and the Company received a letter in November 2025 with a notice that FDA had received the file and assigning a summer 2026 decision date under the Generic Drug User Fee Act (GDUFA).” · SEC filing
  4. ICCCImmuCell · Unaudited financial results for the quarter and nine months ended September 30, 2026Financial results Quote matches the filingSEC ↗

    14 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: · Quote matches the filing

  5. CYTKCytokinetics · aficamtenPDUFA target date (company stated) Quote matches the filingSEC ↗

    15 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: · Quote matches the filing

  6. NTHINeOnc Technologies Holdings · NEO212FDA meeting Meeting date, not a results announcement Quote matches the filingSEC ↗

    18 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: · Quote matches the filing

  7. SVRASavara · molgramostimPDUFA target date (company stated) Quote matches the filingSEC ↗

    23 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: · Quote matches the filing

  8. SNYSanofi · venglustat · type 3 Gaucher disease (GD3)FDA goal date (company stated) Quote matches the filingSEC ↗

    26 days left

    for the FDA decision is November 25, 2026.Details

    Sanofi (SNY) · venglustat · type 3 Gaucher disease (GD3)

    Stage: PDUFASEC filing · “target action date”

    Public float: Unknown (no public float found in SEC filings)

    FDA goal date (company stated):

    The target action date for the FDA decision is November 25, 2026.

    SEC Form 6-K · Filed: · Accession: 0001121404-26-000008 · Last checked: · Quote matches the filing

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “The target action date for the FDA decision is November 25, 2026.” · SEC filing
  9. PYPDPolyPid · D-PLEX100 · Prevention of surgical site infections in patients undergoing abdominal colorectal surgeryPDUFA target date (company stated) Quote matches the filingSEC ↗

    29 days left

    with a PDUFA goal date of November 28, 2026, including potential label expansion beyondDetails

    PolyPid Ltd. (PYPD) · D-PLEX100 · Prevention of surgical site infections in patients undergoing abdominal colorectal surgery

    Stage: PDUFASEC filing · “PDUFA goal date”

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    PolyPid’s management will also review the Company’s plans to maximize the value of D-PLEX₁₀₀, for which a New Drug Application (“NDA”) is under FDA Priority Review with a PDUFA goal date of November 28, 2026, including potential label expansion beyond colorectal surgery and potential geographic expansion.

    SEC Form 6-K · Filed: · Accession: 0001213900-26-113107 · Last checked: · Quote matches the filing

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “The Company anticipates a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act (“PDUFA”) review timeline.” · SEC filing
  10. COGTCogent Biosciences · bezuclastinib and sunitinib · GIST after prior imatinibPDUFA target date (company stated) Quote matches the filingSEC ↗

    31 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: · Quote matches the filing

    Earlier SEC statements (1)
    1. · “PDUFA date of November 30, 2026” · SEC filing
  11. VRTXVertex Pharmaceuticals · povetacicept · IgA nephropathy in adultsPDUFA target date (company stated) Quote matches the filingSEC ↗

    31 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: · Quote matches the filing

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

    34 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: · Quote matches the filing

    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
  13. ANABAnaptysBio · imsidolimab · generalized pustular psoriasisPDUFA target date (company stated) Quote matches the filingSEC ↗

    43 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: · Quote matches the filing

    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
  14. CORTCorcept Therapeutics · relacorilant · Cushing’s syndromePDUFA target date (company stated) Quote matches the filingSEC ↗

    48 days left

    Fee Act (PDUFA) date of December 17, 2026Details

    CORCEPT THERAPEUTICS INC (CORT) · relacorilant · Cushing’s syndrome

    Stage: PDUFASEC filing · “PDUFA) date”

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026

    SEC Form 8-K · Filed: · Accession: 0001628280-26-050607 · Last checked: · Quote matches the filing

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “Corcept expects the resubmission to receive a six-month review.” · SEC filing
  15. MLYSMineralys Therapeutics · lorundrostatPDUFA target date (company stated) Quote matches the filingSEC ↗

    53 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: · Quote matches the filing

    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
  16. GILDGilead Sciences · anito-cel · relapsed or refractory multiple myeloma after at least three prior therapiesPDUFA target date (company stated) Quote matches the filingSEC ↗

    54 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: · Quote matches the filing

    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
  17. PRAXPraxis Precision Medicines · relutrigine · SCN2A and SCN8A developmental and epileptic encephalopathiesPDUFA target date (company stated) Quote matches the filingSEC ↗

    58 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: · Quote matches the filing

    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
  18. VTRSViatris · MR-107A-02 (fast-acting meloxicam) · moderate-to-severe acute painPDUFA target date (company stated) Quote matches the filingSEC ↗

    58 days left

    a PDUFA goal date of December 27, 2026.Details

    Viatris Inc (VTRS) · MR-107A-02 (fast-acting meloxicam) · moderate-to-severe acute pain

    Stage: PDUFASEC filing · “PDUFA goal date”

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    The FDA has assigned a PDUFA goal date of December 27, 2026.

    SEC Form 8-K · Filed: · Accession: 0001792044-26-000037 · Last checked: · Quote matches the filing

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

  19. COGTCogent Biosciences · bezuclastinib · nonadvanced systemic mastocytosisPDUFA target date (company stated) Quote matches the filingSEC ↗

    61 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: · Quote matches the filing

    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
  20. NUVBNuvation Bio · taletrectinib / IBTROZIPDUFA target date (company stated) Quote matches the filingSEC ↗

    66 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: · Quote matches the filing

  21. DYNDyne Therapeutics · zeleciment rostudirsen (DYNE-251) · Duchenne muscular dystrophy amenable to exon 51 skippingPDUFA target date (company stated) Quote matches the filingSEC ↗

    83 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: · Quote matches the filing

    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
  22. INSMInsmed · ARIKAYCE (amikacin liposome inhalation suspension) · Mycobacterium avium complex lung disease, as part of a combination antibacterial drug regimenFDA goal date (company stated) Quote matches the filingSEC ↗

    90 days left

    a target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA).Details

    INSMED Inc (INSM) · ARIKAYCE (amikacin liposome inhalation suspension) · Mycobacterium avium complex lung disease, as part of a combination antibacterial drug regimen

    Stage: PDUFASEC filing · “target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA”

    Public float: Unknown (no public float found in SEC filings)

    FDA goal date (company stated):

    In September 2026, the U.S. Food and Drug Administration (FDA) accepted Insmed’s Supplemental New Drug Application (sNDA) for review of ARIKAYCE for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen. The FDA granted Priority Review to the sNDA and set a target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA).

    SEC Form 8-K · Filed: · Accession: 0001140361-26-041097 · Last checked: · Quote matches the filing

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

  23. PRAXPraxis Precision Medicines · ulixacaltamide · essential tremorPDUFA target date (company stated) Quote matches the filingSEC ↗

    91 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: · Quote matches the filing

    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
  24. PHARPharming Group · Joenja (leniolisib), lower-dose formulation · Activated phosphoinositide 3-kinase delta syndrome (APDS), pediatric patients aged 4–11 years weighing 13–27 kgPDUFA target date (company stated) Quote matches the filingSEC ↗

    92 days left

    target action date of January 30, 2027.Details

    Pharming Group N.V. (PHAR) · Joenja (leniolisib), lower-dose formulation · Activated phosphoinositide 3-kinase delta syndrome (APDS), pediatric patients aged 4–11 years weighing 13–27 kg

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

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    On September 28, 2026, we announced that the FDA had accepted this sNDA and granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027.

    SEC Form 6-K · Filed: · Accession: 0001828316-26-000049 · Last checked: · Quote matches the filing

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027.” · SEC filing
  25. GILDGilead Sciences · lenacapavir oral 300-mg · HIV pre-exposure prophylaxisPDUFA target date (company stated) Quote matches the filingSEC ↗

    95 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: · Quote matches the filing

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

    116 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: · Quote matches the filing

  27. CGEMCullinan Therapeutics · zipalertinibPDUFA target date (company stated) Quote matches the filingSEC ↗

    120 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: · Quote matches the filing

    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
  28. BMRNBiomarin Pharmaceutical · vosoritide · children with achondroplasia; full approval applicationPDUFA target date (company stated) Quote matches the filingSEC ↗

    121 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: · Quote matches the filing

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

    131 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: · Quote matches the filing

    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
  30. ETONEton · LIBERVANT (diazepam buccal film) · seizure clusters, ages 6–11PDUFA target date (company stated) Quote matches the filingSEC ↗

    150 days left

    target action date of March 29, 2027.Details

    ETON (ETON) · LIBERVANT (diazepam buccal film) · seizure clusters, ages 6–11

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

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.

    SEC Form 8-K · Filed: · Accession: 0001437749-26-032600 · Last checked: · Quote matches the filing

About this calendar
Calendar

FDA dates and trial readouts as each company stated them, with SEC original links. 260 programs as of . Free, with no sign-in. No forecasts, prices or signals.

Add to Google Calendar Apple Calendar The subscription follows the filters chosen here. Calendar exports use exact company-stated dates. Period wording remains in the records. No sign-up; ORION stores nothing about subscribers.

How this calendar is made
  • Entries are grouped by their retained period length: an exact date (with its count of days), then a month, quarter, half or year with no count. Calendar subscriptions include exact dates. Period headings describe the window end; each row retains the company's exact wording. A date is the target action date the company stated.
  • Company size is the public float (market value of shares held by non-affiliates) on the company’s latest cover, with its reference date and SEC link. It does not decide which programs are listed.
  • Stage repeats the SEC filing or ClinicalTrials.gov registration wording. Without supporting wording, it is Not stated. Mixed phases retain their exact wording beside the source link.
  • Medicine research links use an NCT number stated in the SEC filing or company announcement, or a ClinicalTrials.gov match with sponsor, medicine and phase evidence. A registry match is labelled “matched by ORION (not stated in the filing)”.
  • Rows link to the program or company page. For a stated date, month, quarter, half or year, the period ends on its calendar end. Ambiguous qualifiers retain their wording without inferred endpoints.
  • Ambiguous periods and events without a date retain the literal wording in a separate section. No calendar date or countdown is created; these records are excluded from calendar subscriptions.
  • Active windows have no resolution filing held and end on or after today (UTC). A row with resolution evidence is shown in Results disclosed. Other rows move to Window ended after the stated period ends. Earlier wording and filing links remain available.
  • Event types distinguish trial data, enrollment completion, site activation and event-based analysis. Financial results and FDA meetings have their own filters. Audit status remains in the SEC wording. The type follows the SEC wording.
  • Displayed items need a true public-display field and a matching SEC quote and timing proof. Machine extraction does not add a founder review.
  • “Wording changed” opens the earlier sentences, each with its date and filing.
  • No forecast, price, score or signal. The calendar repeats what companies wrote.
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.