ORION Biotech Catalyst Calendar
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Free biotech catalyst calendar

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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250 programs as of

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

Window ends in: 2027

Grouped by the period end. The company's wording is retained in each row; no countdown is shown.

  1. ROIVRoivant Sciences · IMVT-1402Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2027

    trial in myasthenia gravis 2027Details

    Roivant Sciences Ltd. (ROIV) · IMVT-1402

    Stage: Not stated

    Public float (as of ): $9.8B (SEC filing) · Over $2B

    Period the company stated: 2027

    Topline data from potentially registrational trial in myasthenia gravis 2027

    SEC Form 10-Q · Filed: · Accession: 0001635088-26-000090 · Last checked: · Matched

    Earlier SEC statements (5)
    1. · “Topline data from potentially registrational trial in myasthenia gravis 2027” · SEC filing
    2. · “Topline data from potentially registrational trial in myasthenia gravis 2027” · SEC filing
    3. · “Topline data from potentially registrational trial in myasthenia gravis 2027” · SEC filing
    4. · “Topline data from potentially registrational trial in myasthenia gravis 2027” · SEC filing
    5. · “Topline data from potentially registrational trial in myasthenia gravis 2027” · SEC filing
  2. RVMDRevolution Medicines · RMC-5127Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2027

    initial clinical data in 2027.Details

    Revolution Medicines, Inc. (RVMD) · RMC-5127

    Stage: Not stated

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

    Period the company stated: 2027

    share initial clinical data in 2027.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-335104 · Last checked: · Matched

  3. RVMDRevolution Medicines · daraxonrasibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2027

    initial readout in 2027.Details

    Revolution Medicines, Inc. (RVMD) · daraxonrasib

    Stage: Phase 3SEC filing · “Phase 3”

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

    Period the company stated: 2027

    Enrollment in the global Phase 3 RASolve 301 trial evaluating daraxonrasib in patients with previously treated RAS mutant NSCLC is expected to be completed this year, supporting an anticipated initial readout in 2027.

    ClinicalTrials.gov NCT06881784 · matched by ORION (not stated in the filing)

    Matching evidence
    Sponsor
    Filing issuer: Revolution Medicines, Inc. · Registry: Revolution Medicines, Inc.
    Medicine
    Filing: daraxonrasib · Registry: daraxonrasib
    Phase
    Filing: Phase 3 · Registry: Phase 3

    Registration title: Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

    Registry observed:

    ClinicalTrials.gov: “Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)”

    SEC Form 8-K · Filed: · Accession: 0001193125-26-335039 · Last checked: · Matched

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

    Period the company stated: 2027

    and report initial data in 2027.Details

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

    Stage: Not stated

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

    Period the company stated: 2027

    Shattuck expects to initiate a Phase 1 healthy volunteer clinical trial of SL-846 and report initial data in 2027.

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

  5. SYRESpyre Therapeutics · SPY001 / SPY002 / SPY003 and pairwise combinationsTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2027

    Part B are expected in 2027.Details

    Spyre Therapeutics, Inc. (SYRE) · SPY001 / SPY002 / SPY003 and pairwise combinations

    Stage: Not stated

    Public float (as of ): $1.1B (SEC filing) · $500M–$2B

    Period the company stated: 2027

    Topline induction data from Part B are expected in 2027.

    SEC Form 8-K · Filed: · Accession: 0001636282-26-000113 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “Part B induction data (all cohorts) remain on track for 2027.” · SEC filing
    2. · “Part B induction data (all cohorts) remain on track for 2027.” · SEC filing
  6. XENEXenon Pharmaceuticals · NBI-921355Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2027

    1b study are expected in 2027.Details

    Xenon Pharmaceuticals Inc. (XENE) · NBI-921355

    Stage: Phase 1SEC filing · “Phase 1b; Phase 1b”

    Public float (as of ): $2.4B (SEC filing) · Over $2B

    Period the company stated: 2027

    a Phase 1b study is ongoing for NBI-921355, an investigational, selective inhibitor of voltage-gated sodium channels Nav1.2 and Nav1.6 in development for the potential treatment of certain types of epilepsy. Data from the Phase 1b study are expected in 2027.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-338244 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “Data from the Phase 1b study are expected in 2027.” · SEC filing
    2. · “Data from the Phase 1b study are expected in 2027.” · SEC filing
  7. ZBIOZenas BioPharma · ZB021Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2027

    results anticipated in 2027.Details

    Zenas BioPharma, Inc. (ZBIO) · ZB021

    Stage: Not stated

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

    Period the company stated: 2027

    Upon completion and evaluation of the SAD and MAD study, Zenas plans to initiate a proof-of-concept (POC) trial in North America to evaluate clinical activity and safety in psoriasis patients with results anticipated in 2027.

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

    Earlier SEC statements (1)
    1. · “Upon completion and evaluation of the SAD and MAD study, Zenas plans to initiate a proof-of-concept (POC) trial in North America to evaluate clinical activity and safety in psoriasis patients with results anticipated in 2027.” · SEC filing

Window ends in: 2028

Grouped by the period end. The company's wording is retained in each row; no countdown is shown.

  1. ANABAnaptysBio · dostarlimabTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2028

    Data expected in 2028Details

    ANAPTYSBIO, INC (ANAB) · dostarlimab

    Stage: Not stated

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

    Period the company stated: 2028

    Data expected in 2028

    SEC Form EX-99.1 · Filed: · Accession: 0001193125-26-219500 · Last checked: · Matched

  2. BCTXBriaCell Therapeutics · BriaPro TILsRxOther MatchedSEC ↗Watch

    Period the company stated: 2028

    to be initiated in 2028, pending funding.Details

    BriaCell Therapeutics Corp. (BCTX) · BriaPro TILsRx

    Stage: Not stated

    Public float (as of ): $94M (SEC filing) · Under $500M

    Period the company stated: 2028

    Human clinical studies are expected to be initiated in 2028, pending funding.

    SEC timing context:

    BriaPro also expects to select at least one TILsRx candidate to advance into IND enabling studies.

    SEC Form 8-K · Filed: · Accession: 0001493152-26-030286 · Last checked: · Matched

  3. KURAKura Oncology · ziftomenibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2028

    chemotherapy setting in 2028Details

    Kura Oncology, Inc. (KURA) · ziftomenib

    Stage: Not stated

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

    Period the company stated: 2028

    topline results from the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting in 2028

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-346884 · Last checked: · Matched

    Earlier SEC statements (4)
    1. · “topline results from the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting in 2028” · SEC filing
    2. · “topline results from KOMET-017, anticipated in 2028” · SEC filing
    3. · “topline results from the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting in 2028” · SEC filing
    4. · “topline results from KOMET-017, anticipated in 2028” · SEC filing
About this calendar
Calendar

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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How this calendar is made
  • Entries are grouped by their retained period length: a date (with its count of days), a month (counted to its last day), then a quarter, half or year with no count. 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.

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Window ended

The company-stated period has ended. These records retain their wording and filing links.

1 programs as of

Window ends in: Q1 2026

Grouped by the period end. The company's wording is retained in each row; no countdown is shown.

  1. ICCCImmuCell · Re-TainOther Study and data analysis completion target MatchedSEC ↗Watch

    Period the company stated: first quarter of 2026

    data analysis during the first quarter of 2026.Details

    IMMUCELL CORP /DE/ (ICCC) · Re-Tain

    Stage: Not stated

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

    Period the company stated: first quarter of 2026

    It is our objective to complete the study and data analysis during the first quarter of 2026.

    SEC timing context:

    During the second half of 2025, we are testing market acceptance of Re-Tain ® in collaboration with Michigan State University through Investigational Product use with inventory on hand that now has a relatively short shelf life.

    SEC Form 10-Q · Filed: · Accession: 0001437749-25-034817 · Last checked: · Matched

    Window ended . No resolution filing is held in this record as of .

Timing without a stated calendar date

These SEC statements retain an ambiguous period or an event trigger. No date or countdown is assigned.

3 records as of

no date stated

  1. ICCCImmuCell · Audited annual financial statementsFinancial results MatchedSEC ↗Watch

    Period the company stated: Not stated

    We have audited the accompanying balance sheets of ImmuCell Corporation (the “Company”) as ofDetails

    IMMUCELL CORP /DE/ (ICCC) · Audited annual financial statements

    Stage: Not stated

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

    Period the company stated: Not stated

    We have audited the accompanying balance sheets of ImmuCell Corporation (the “Company”) as of December 31, 2025 and 2024, and the related statements of operations, stockholders’ equity, and cash flows for the years ended December 31, 2025 and 2024, and the related notes (collectively referred to as the “financial statements”).

    SEC Form 10-K · Filed: · Accession: 0001437749-26-010339 · Last checked: · Matched

  2. ICCCImmuCell · Re-TainOther MatchedSEC ↗Watch

    Period the company stated: Not stated

    On December 23, 2025, we made the decision to cease our efforts to obtain FDA approval ofDetails

    IMMUCELL CORP /DE/ (ICCC) · Re-Tain

    Stage: Not stated

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

    Period the company stated: Not stated

    On December 23, 2025, we made the decision to cease our efforts to obtain FDA approval of Re-Tain ® while continuing the stability testing and investigational studies to evaluate Re-Tain ® performance.

    SEC Form 10-Q · Filed: · Accession: 0001437749-26-027668 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “ImmuCell will complete ongoing investigational studies with Re-Tain ® to assess opportunities for an improved set of claims for preventing and treating mastitis in dairy cows.” · SEC filing
    2. · ““On the topic of Re-Tain ®,” Mr. Fiori further commented, “our Investigational Product use of Re-Tain ® is under way, in partnership with Michigan State University. We will continue to collect market feedback about product performance in the field over the remainder of 2025 and into 2026.”” · SEC filing

Ambiguous periods as stated

  1. RZLTRezolute · ersodetugTopline/data readout MatchedSEC ↗Watch

    Period the company stated: mid-December 2026

    topline data are expected mid-December 2026.Details

    Rezolute, Inc. (RZLT) · ersodetug

    Stage: Phase 3SEC filing · “Phase 3”

    Public float (as of ): $203M (SEC filing) · Under $500M

    Period the company stated: mid-December 2026

    REDWOOD CITY, Calif., October 14, 2026 – Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or Company), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today announced that the open-label Phase 3 study of ersodetug in tumor HI (upLIFT) is now fully enrolled and topline data are expected mid-December 2026.

    SEC Form 8-K · Filed: · Accession: 0001104659-26-115874 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “We anticipate completing enrollment and announcing topline results from the study before the end of 2026.” · SEC filing
    2. · “The Company anticipates completing enrollment and announcing topline results from the study in the second half of calendar 2026.” · SEC filing

Results disclosed

An SEC resolution filing is held in these records. The original schedule, quote and source remain available.

47 programs as of

Dates the companies stated

  1. EXELExelixis · cabozantinib · previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumorsPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of April 3, 2025Details

    EXELIXIS, INC. (EXEL) · cabozantinib · previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumors

    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 April 3, 2025

    SEC Form filing · Filed: · Accession: 0000939767-25-000019 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (8)
    1. · “PDUFA target action date of April 3, 2025” · SEC filing
    2. · “Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” · SEC filing
    3. · “PDUFA action date of April 3, 2025” · SEC filing
    4. · “Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” · SEC filing
    5. · “PDUFA target action date of April 3, 2025” · SEC filing
    6. · “Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” · SEC filing
    7. · “PDUFA target action date of April 3, 2025” · SEC filing
    8. · “Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025” · SEC filing
  2. REGNRegeneron Pharmaceuticals · dupilumab · chronic spontaneous urticaria in adults and adolescentsPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of April 18, 2025Details

    REGENERON PHARMACEUTICALS, INC. (REGN) · dupilumab · chronic spontaneous urticaria in adults and adolescents

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $54.8B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    target action date of April 18, 2025

    SEC Form filing · Filed: · Accession: 0001804220-25-000011 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (2)
    1. · “target action date of April 18, 2025” · SEC filing
    2. · “Food and Drug Administration (FDA) decision by April 18, 2025” · SEC filing
  3. REGNRegeneron Pharmaceuticals · aflibercept 8 mg · wet age-related macular degeneration and diabetic macular edema; two-year data labelPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of April 20, 2025Details

    REGENERON PHARMACEUTICALS, INC. (REGN) · aflibercept 8 mg · wet age-related macular degeneration and diabetic macular edema; two-year data label

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $54.8B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    target action date of April 20, 2025

    SEC Form filing · Filed: · Accession: 0001804220-25-000011 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (2)
    1. · “target action date of April 20, 2025” · SEC filing
    2. · “PDUFA date of April 20, 2025” · SEC filing
  4. REGNRegeneron Pharmaceuticals · dupilumab · bullous pemphigoidPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of June 20, 2025Details

    REGENERON PHARMACEUTICALS, INC. (REGN) · dupilumab · bullous pemphigoid

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $54.8B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    target action date of June 20, 2025

    SEC Form filing · Filed: · Accession: 0001804220-25-000022 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “target action date of June 20, 2025” · SEC filing
  5. REGNRegeneron Pharmaceuticals · linvoseltamab · relapsed or refractory multiple myelomaPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of July 10, 2025Details

    REGENERON PHARMACEUTICALS, INC. (REGN) · linvoseltamab · relapsed or refractory multiple myeloma

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $54.8B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    target action date of July 10, 2025

    SEC Form filing · Filed: · Accession: 0001804220-25-000022 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “target action date of July 10, 2025” · SEC filing
  6. REGNRegeneron Pharmaceuticals · odronextamab · relapsed or refractory follicular lymphomaPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of July 30, 2025Details

    REGENERON PHARMACEUTICALS, INC. (REGN) · odronextamab · relapsed or refractory follicular lymphoma

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $54.8B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    target action date of July 30, 2025

    SEC Form filing · Filed: · Accession: 0001804220-25-000022 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “target action date of July 30, 2025” · SEC filing
  7. BCTXBriaCell Therapeutics · BriaCell public offering 2026-01-15Other MatchedSEC ↗Watch

    is expected to close on January 15, 2026, subject to satisfaction of customary closingDetails

    BriaCell Therapeutics Corp. (BCTX) · BriaCell public offering 2026-01-15

    Stage: Not stated

    Public float (as of ): $94M (SEC filing) · Under $500M

    Date the company stated:

    The offering is expected to close on January 15, 2026, subject to satisfaction of customary closing conditions.

    SEC Form 8-K · Filed: · Accession: 0001493152-26-002430 · Last checked: · Matched

    Resolution filing (SEC filing)

  8. ICCCImmuCell · unaudited financial results for the quarter and year ended December 31, 2025Financial results MatchedSEC ↗Watch

    On March 4, 2026 ImmuCell Corporation (the "Company") issued a press release announcing itsDetails

    IMMUCELL CORP /DE/ (ICCC) · unaudited financial results for the quarter and year ended December 31, 2025

    Stage: Not stated

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

    Date the company stated:

    On March 4, 2026 ImmuCell Corporation (the "Company") issued a press release announcing its unaudited financial results for the quarter and year ended December 31, 2025.

    SEC Form 8-K · Filed: · Accession: 0001437749-26-006912 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “The Company is planning to release its full, unaudited financial results for the quarter and year ended December 31, 2025 after the market closes on Wednesday, February 25, 2026 and is planning to host a conference call on Thursday, February 26, 2026 at 9:00 AM ET to discuss these results.” · SEC filing
  9. NTHINeOnc Technologies Holdings · NEO212-01Topline/data readout MatchedSEC ↗Watch

    call and webcast on Wednesday, March 4, 2026, at 9:00 a.m. Eastern Time to presentDetails

    NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI) · NEO212-01

    Stage: OtherSEC filing · “Phase 1; Phase 1/2”

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

    Date the company stated:

    On February 27, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that it will host an investor conference call and webcast on Wednesday, March 4, 2026, at 9:00 a.m. Eastern Time to present initial data from the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial.

    SEC Form 8-K · Filed: · Accession: 0001829126-26-001755 · Last checked: · Matched

    Resolution filing (SEC filing)

  10. RCKTRocket Pharmaceuticals · marnetegragene autotemcel (KRESLADI) · severe leukocyte adhesion deficiency-IPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date for March 28, 2026Details

    ROCKET PHARMACEUTICALS, INC. (RCKT) · marnetegragene autotemcel (KRESLADI) · severe leukocyte adhesion deficiency-I

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

    Public float (as of ): $212M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date for March 28, 2026

    SEC Form filing · Filed: · Accession: 0001140361-26-006981 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (4)
    1. · “PDUFA date of March 28, 2026” · SEC filing
    2. · “PDUFA date of March 28, 2026” · SEC filing
    3. · “PDUFA date set by the FDA is March 28, 2026” · SEC filing
    4. · “PDUFA date set by the FDA is March 28, 2026” · SEC filing
  11. DNLIDenali Therapeutics · tividenofusp alfa (DNL310) · Hunter syndromePDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of April 5, 2026Details

    Denali Therapeutics Inc. (DNLI) · tividenofusp alfa (DNL310) · Hunter syndrome

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

    Public float (as of ): $1.1B (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date of April 5, 2026

    SEC Form filing · Filed: · Accession: 0001714899-26-000020 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (6)
    1. · “PDUFA date for our lead asset, tividenofusp alfa, is currently April 5, 2026” · SEC filing
    2. · “Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026” · SEC filing
    3. · “PDUFA target date has been extended from January 5, 2026, to April 5, 2026” · SEC filing
    4. · “Prescription Drug User Fee Act (PDUFA) target date was extended from January 5, 2026, to April 5, 2026” · SEC filing
    5. · “Prescription Drug User Fee Act (PDUFA) target date has been extended from January 5, 2026, to April 5, 2026” · SEC filing
    6. · “PDUFA action date from January 5, 2026 to April 5, 2026” · SEC filing
  12. AXSMAxsome Therapeutics · AXS-05 · agitation associated with Alzheimer disease dementiaPDUFA target date (company stated) MatchedSEC ↗Watch

    PDUFA target action date of April 30, 2026Details

    Axsome Therapeutics, Inc. (AXSM) · AXS-05 · agitation associated with Alzheimer disease dementia

    Stage: PDUFASEC filing · “PDUFA target action date”

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

    PDUFA target date (company stated):

    PDUFA target action date of April 30, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-062421 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (5)
    1. · “Prescription Drug User Fee Act (PDUFA) date of April 30, 2026” · SEC filing
    2. · “Prescription Drug User Fee Act (PDUFA) action goal date of April 30, 2026” · SEC filing
    3. · “Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026” · SEC filing
    4. · “PDUFA target action (April 30, 2026” · SEC filing
    5. · “PDUFA action goal date of April 30, 2026” · SEC filing
  13. ARGXargenx · efgartigimod · anti-AChR-antibody-negative generalized myasthenia gravisPDUFA target date (company stated) MatchedSEC ↗Watch

    triple seronegative) is May 10, 2026Details

    ARGENX SE (ARGX) · efgartigimod · anti-AChR-antibody-negative generalized myasthenia gravis

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

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

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG (MuSK+, LRP4+ and triple seronegative) is May 10, 2026

    SEC Form filing · Filed: · Accession: 0001628280-26-031739 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (7)
    1. · “Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026” · SEC filing
    2. · “target action date of May 10, 2026” · SEC filing
    3. · “PDUFA target action date of May 10, 2026” · SEC filing
    4. · “PDUFA date of May 10, 2026” · SEC filing
    5. · “Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG (MuSK+, LRP4+ and triple seronegative) is May 10, 2026” · SEC filing
    6. · “PDUFA target action date of May 10, 2026” · SEC filing
    7. · “Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026” · SEC filing
  14. BCTXBriaCell Therapeutics · BriaCell public offering 2026-06-02Other MatchedSEC ↗Watch

    is expected to close on June 2, 2026, subject to satisfaction of customary closingDetails

    BriaCell Therapeutics Corp. (BCTX) · BriaCell public offering 2026-06-02

    Stage: Not stated

    Public float (as of ): $94M (SEC filing) · Under $500M

    Date the company stated:

    The offering is expected to close on June 2, 2026, subject to satisfaction of customary closing conditions.

    SEC Form 8-K · Filed: · Accession: 0001493152-26-026953 · Last checked: · Matched

    Resolution filing (SEC filing)

  15. IONSIonis Pharmaceuticals · olezarsen · severe hypertriglyceridemiaPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of June 30, 2026Details

    IONIS PHARMACEUTICALS INC (IONS) · olezarsen · severe hypertriglyceridemia

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

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

    PDUFA target date (company stated):

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

    SEC Form filing · Filed: · Accession: 0001140361-26-017637 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (4)
    1. · “Prescription Drug User Fee Act, or PDUFA, action date of June 30, 2026” · SEC filing
    2. · “action date of June 30, 2026” · SEC filing
    3. · “PDUFA action date of June 30, 2026” · SEC filing
    4. · “expect a Prescription Drug User Fee Act (“PDUFA”) target action date in 2026” · SEC filing
  16. VERAVera Therapeutics · atacicept · IgA nephropathy in adultsPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date of July 7, 2026Details

    Vera Therapeutics, Inc. (VERA) · atacicept · IgA nephropathy in adults

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

    Public float (as of ): $1.3B (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-212143 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (7)
    1. · “Prescription Drug User Fee Act (PDUFA) date of July 7, 2026” · SEC filing
    2. · “PDUFA target action date of July 7, 2026” · SEC filing
    3. · “PDUFA date of July 7, 2026” · SEC filing
    4. · “PDUFA date of July 7, 2026” · SEC filing
    5. · “Prescription Drug User Fee Act (PDUFA) date of July 7, 2026” · SEC filing
    6. · “PDUFA target action date of July 7, 2026” · SEC filing
    7. · “PDUFA date of July 7, 2026” · SEC filing

All companies A–Z

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.