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.

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

    1 meeting scheduled for July 9, 2026.Details

    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:

    The written feedback was provided in advance of a Type B End-of-Phase 1 meeting scheduled for July 9, 2026.

    SEC timing context:

    CALABASAS, Calif., July 15, 2026 — NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) (“NeOnc” or the “Company”), a clinical-stage life sciences company focused on the development of treatments for central nervous system cancers, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the chemistry, manufacturing and controls (“CMC”) development program for NEO212, the Company’s novel temozolomide-perillyl alcohol conjugate.

    SEC Form 8-K · Filed: · Accession: 0001829126-26-007585 · Last checked: · Matched

    Resolution filing (SEC filing)

  2. NTHINeOnc Technologies Holdings · NEO100-01Topline/data readout MatchedSEC ↗Watch

    study will be presented on August 12, 2026.Details

    NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI) · NEO100-01

    Stage: Phase 2SEC filing · “Phase 2a”

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

    Date the company stated:

    On August 10, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release reporting second quarter financial results and confirmed that topline results from its fully enrolled Phase 2a NEO100 study will be presented on August 12, 2026.

    SEC Form 8-K · Filed: · Accession: 0001829126-26-008543 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (3)
    1. · “The Company expects to report top-line data from the fully enrolled NEO100-01 Phase 2a trial by the end of July 2026, representing what NeOnc believes may be one of the most important clinical milestones in the Company’s history.” · SEC filing
    2. · “Top-line data readout anticipated in May 2026” · SEC filing
    3. · “Top-line data readout anticipated in early 2026.” · SEC filing
  3. NTHINeOnc Technologies Holdings · Registered direct offeringOther MatchedSEC ↗Watch

    is expected to close on September 10, 2026, subject to the satisfaction of customary closingDetails

    NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI) · Registered direct offering

    Stage: Not stated

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

    Date the company stated:

    The Offering is expected to close on September 10, 2026, subject to the satisfaction of customary closing conditions (the “Closing Date”).

    SEC Form 8-K · Filed: · Accession: 0001829126-26-009977 · Last checked: · Matched

    Resolution filing (SEC filing)

  4. IONSIonis Pharmaceuticals · zilganersen · Alexander diseasePDUFA target date (company stated) MatchedSEC ↗Watch

    PDUFA target action date of September 22, 2026Details

    IONIS PHARMACEUTICALS INC (IONS) · zilganersen · Alexander disease

    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 September 22, 2026

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

    Resolution filing (SEC filing)

    Earlier SEC statements (6)
    1. · “Prescription Drug User Fee Act, or PDUFA, action date of September 22, 2026” · SEC filing
    2. · “PDUFA action date of September 22, 2026” · SEC filing
    3. · “PDUFA target action date of September 22, 2026” · SEC filing
    4. · “Prescription Drug User Fee Act (PDUFA) action date of September 22, 2026” · SEC filing
    5. · “PDUFA date set for September 22, 2026” · SEC filing
    6. · “Prescription Drug User Fee Act action date of September 22, 2026” · SEC filing
  5. MIRMMirum Pharmaceuticals · zilurgisertib · fibrodysplasia ossificans progressivaPDUFA target date (company stated) MatchedSEC ↗Watch

    the zilurgisertib NDA is September 26, 2026Details

    Mirum Pharmaceuticals, Inc. (MIRM) · zilurgisertib · fibrodysplasia ossificans progressiva

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

    Public float (as of ): $2.3B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026

    SEC Form filing · Filed: · Accession: 0001759425-26-000044 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (4)
    1. · “PDUFA date of September 26, 2026” · SEC filing
    2. · “Prescription Drug User Fee Act (PDUFA) date of September 26, 2026” · SEC filing
    3. · “PDUFA date of September 26, 2026” · SEC filing
    4. · “Prescription Drug User Fee Act (PDUFA) date of September 26, 2026” · SEC filing

Months the companies stated

  1. PTCTPTC Therapeutics · vatiquinone · Friedreich ataxiaNDA/BLA submission MatchedSEC ↗Watch

    of FA in the United States in December 2024.Details

    PTC THERAPEUTICS, INC. (PTCT) · vatiquinone · Friedreich ataxia

    Stage: Not stated

    Public float (as of ): $3.3B (SEC filing) · Over $2B

    Month the company stated:

    The Company plans to submit an NDA for vatiquinone for the treatment of FA in the United States in December 2024.

    SEC Form 10-Q · Filed: · Accession: 0001070081-24-000023 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (2)
    1. · “We plan to submit an NDA for vatiquinone for the treatment of FA in the United States in December 2024.” · SEC filing
    2. · “PTC plans to submit an NDA for vatiquinone for the treatment of Friedreich ataxia in December 2024.” · SEC filing
  2. EXELExelixis · cabozantinib · previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumorsAdvisory committee MatchedSEC ↗Watch

    (ODAC) meeting in March 2025Details

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

    Stage: Not stated

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

    Month the company stated:

    In November 2024, we announced that our sNDA would be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025

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

    Resolution filing (SEC filing)

  3. NTHINeOnc Technologies Holdings · NEO100-01Other MatchedSEC ↗Watch

    2a enrollment expected by September 2025.Details

    NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI) · NEO100-01

    Stage: Phase 2SEC filing · “Phase 2a”

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

    Month the company stated:

    Full Phase 2a enrollment expected by September 2025.

    SEC timing context:

    NEO100-01 – Intranasal therapy for malignant gliomas

    SEC Form 8-K · Filed: · Accession: 0001829126-25-006673 · Last checked: · Matched

    Resolution filing (SEC filing)

  4. REGNRegeneron Pharmaceuticals · cemiplimab · adjuvant cutaneous squamous cell carcinomaPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date in October 2025Details

    REGENERON PHARMACEUTICALS, INC. (REGN) · cemiplimab · adjuvant cutaneous squamous cell carcinoma

    Stage: PDUFASEC filing · “target action date”

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

    Month the company stated:

    target action date in October 2025

    SEC Form filing · Filed: · Accession: 0000872589-25-000017 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “FDA decision on sBLA (October 2025” · SEC filing
  5. REGNRegeneron Pharmaceuticals · dupilumab · allergic fungal rhinosinusitisPDUFA target date (company stated) MatchedSEC ↗Watch

    target action date in February 2026Details

    REGENERON PHARMACEUTICALS, INC. (REGN) · dupilumab · allergic fungal rhinosinusitis

    Stage: PDUFASEC filing · “target action date”

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

    Month the company stated:

    target action date in February 2026

    SEC Form filing · Filed: · Accession: 0000872589-26-000004 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “FDA decision on sBLA for Dupixent in AFRS (February 2026” · SEC filing
  6. BCTXBriaCell Therapeutics · BriaPro sCD80 license transactionOther MatchedSEC ↗Watch

    is expected to close by the end of March 2026, subject to certain conditions includingDetails

    BriaCell Therapeutics Corp. (BCTX) · BriaPro sCD80 license transaction

    Stage: Not stated

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

    Month the company stated:

    The Transaction is expected to close by the end of March 2026, subject to certain conditions including (i) approval of the disinterested shareholders of BriaPro, and (ii) receipt of a third-party valuation confirming that the Transaction is occurring at fair market value.

    SEC timing context:

    On February 18, 2026, the Company and BriaPro, announced that they have entered into a definitive purchase agreement (the “Purchase Agreement”) pursuant to which BriaPro has agreed to purchase BriaCell’s exclusive license to develop and commercialize Soluble CD80 (“sCD80”) as a biologic agent for the treatment of cancer and other associated assets (the “Transaction”). Under the terms of the Purchase Agreement, BriaPro gains the worldwide rights to develop and commercialize sCD80 as a therapeutic agent for the treatment of cancer, while UMBC holds all rights, title and interest in the inventions and the patent, except for certain rights retained by the United States Government. BriaPro will pay 2% royalties to UMBC upon the commercialization of the product plus other development costs. As part of the Transaction, BriaCell will make available to BriaPro up to $3 million to fund research and development efforts (the “Credit Facility”). Each drawdown under the Credit Facility will be subject to BriaCell’s approval regarding the use of funds. As consideration for the transfer of the exclusive license and the Credit Facility, BriaPro will issue to BriaCell 23,972,589 Common Shares at an aggregate value of approximately C$1.18M, increasing BriaCell’s interest in BriaPro to approximately 78% post-transaction.

    SEC Form 10-Q · Filed: · Accession: 0001493152-26-009557 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “The Transaction is expected to close on or around March 12, 2026, subject to certain conditions including (i) approval of the disinterested shareholders of BriaPro, and (ii) receipt of a third-party valuation confirming that the Transaction is occurring at fair market value.” · SEC filing
  7. TRDAEntrada Therapeutics · ENTR-601-45Topline/data readout MatchedSEC ↗Watch

    dose ("MAD") data in October 2026.Details

    Entrada Therapeutics, Inc. (TRDA) · ENTR-601-45

    Stage: Not stated

    Public float (as of ): $191M (SEC filing) · Under $500M

    Month the company stated:

    We expect to report our Cohort 1 ELEVATE-45-201 multiple ascending dose ("MAD") data in October 2026.

    SEC Form 10-Q · Filed: · Accession: 0001689375-26-000054 · Last checked: · Matched

    Company reported on (SEC filing)

    Earlier SEC statements (1)
    1. · “We expect to report our Cohort 1 ELEVATE-45-201 multiple ascending dose ("MAD") data in October 2026.” · SEC filing
  8. VSTMVerastem · VS-7375Topline/data readout MatchedSEC ↗Watch

    VS-7375 clinical data in October 2026.Details

    Verastem, Inc. (VSTM) · VS-7375

    Stage: Not stated

    Public float (as of ): $253M (SEC filing) · Under $500M

    Month the company stated:

    Report updated VS-7375 clinical data in October 2026.

    SEC Form 8-K · Filed: · Accession: 0001104659-26-092058 · Last checked: · Matched

    Company reported on (SEC filing)

    Earlier SEC statements (1)
    1. · “Report updated VS-7375 clinical data in October 2026.” · SEC filing

Window ends in: Q4 2024

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

  1. EXELExelixis · cabozantinib + atezolizumab · metastatic castration-resistant prostate cancerNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: during the fourth quarter of 2024

    submit an sNDA to the FDA during the fourth quarter of 2024.Details

    EXELIXIS, INC. (EXEL) · cabozantinib + atezolizumab · metastatic castration-resistant prostate cancer

    Stage: Not stated

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

    Period the company stated: during the fourth quarter of 2024

    We intend to submit an sNDA to the FDA during the fourth quarter of 2024.

    SEC Form 10-Q · Filed: · Accession: 0000939767-24-000150 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “Exelixis intends to submit an sNDA to the FDA for cabozantinib in combination with atezolizumab for mCRPC in the fourth quarter of 2024.” · SEC filing
  2. REGNRegeneron Pharmaceuticals · Dupixent · bullous pemphigoidNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: fourth quarter 2024

    submission planned for fourth quarter 2024Details

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

    Stage: Not stated

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

    Period the company stated: fourth quarter 2024

    BP sBLA submission planned for fourth quarter 2024

    SEC Form 8-K · Filed: · Accession: 0001804220-24-000038 · Last checked: · Matched

    Resolution filing (SEC filing)

Window ends in: Q1 2025

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

  1. AXSMAxsome Therapeutics · AXS-14 · fibromyalgiaNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: 1Q 2025

    AXS-14 in fibromyalgia (1Q 2025)Details

    Axsome Therapeutics, Inc. (AXSM) · AXS-14 · fibromyalgia

    Stage: Not stated

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

    Period the company stated: 1Q 2025

    NDA submission for AXS-14 in fibromyalgia (1Q 2025)

    SEC Form 8-K · Filed: · Accession: 0000950170-25-021801 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (4)
    1. · “AXS-14 for fibromyalgia, NDA submission (1Q 2025)” · SEC filing
    2. · “NDA submission for AXS-14 for the management of fibromyalgia anticipated November 2024” · SEC filing
    3. · “Axsome is completing preparations for the submission of the NDA for AXS-14 for the management of fibromyalgia and expects to submit the NDA to the FDA in November 2024.” · SEC filing
    4. · “AXS-14 for fibromyalgia, NDA submission (November 2024)” · SEC filing

Window ends in: Q3 2025

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

  1. AXSMAxsome Therapeutics · AXS-05 · Alzheimer’s disease agitationNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: 3Q 2025

    agitation on track for 3Q 2025Details

    Axsome Therapeutics, Inc. (AXSM) · AXS-05 · Alzheimer’s disease agitation

    Stage: Not stated

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

    Period the company stated: 3Q 2025

    sNDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025

    SEC Form 8-K · Filed: · Accession: 0000950170-25-101624 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (12)
    1. · “NDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025” · SEC filing
    2. · “Axsome is on track to submit the sNDA to the FDA in the third quarter of 2025.” · SEC filing
    3. · “AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025)” · SEC filing
    4. · “The Company is on track to submit the sNDA in the third quarter of 2025.” · SEC filing
    5. · “NDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025” · SEC filing
    6. · “AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025)” · SEC filing
    7. · “Axsome anticipates submitting the planned sNDA in the third quarter of 2025.” · SEC filing
    8. · “Based on the results from these studies, Axsome plans to submit a New Drug Application (NDA) for AXS-05 for the treatment of Alzheimer’s disease agitation to the FDA in the second half of 2025.” · SEC filing
    9. · “AXS-05 for Alzheimer’s disease agitation, NDA submission (2H 2025)” · SEC filing
    10. · “planned NDA submission of AXS-05 in Alzheimer’s disease agitation, which is targeted for the second half of 2025.” · SEC filing
    11. · “Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from these studies.” · SEC filing
    12. · “Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from the above controlled and long-term studies.” · SEC filing

Window ends in: Q1 2026

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

  1. AXSMAxsome Therapeutics · AXS-12 · cataplexy in narcolepsyNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: 1Q 2026

    NDA submission (1Q 2026)Details

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

    Stage: Not stated

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

    Period the company stated: 1Q 2026

    AXS-12 for narcolepsy, NDA submission (1Q 2026)

    SEC Form 8-K · Filed: · Accession: 0001193125-26-062421 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (11)
    1. · “Axsome anticipates completing the NDA submission in January 2026.” · SEC filing
    2. · “Axsome plans to submit an NDA to the FDA for AXS-12 for the treatment of cataplexy in narcolepsy in the fourth quarter of 2025.” · SEC filing
    3. · “AXS-12 for narcolepsy, NDA submission (4Q 2025)” · SEC filing
    4. · “NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 4Q 2025” · SEC filing
    5. · “Axsome plans to submit an NDA to the FDA for AXS-12 for the treatment of cataplexy in narcolepsy in the fourth quarter of 2025.” · SEC filing
    6. · “AXS-12 for narcolepsy, NDA submission (4Q 2025)” · SEC filing
    7. · “The Company anticipates submitting an NDA to the FDA in the second half of 2025.” · SEC filing
    8. · “NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 2H 2025” · SEC filing
    9. · “AXS-12 for narcolepsy, NDA submission (2H 2025)” · SEC filing
    10. · “Based on the results from these studies, Axsome plans to submit an NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy to the FDA in the second half of 2025.” · SEC filing
    11. · “AXS-12 for narcolepsy, NDA submission (2H 2025)” · SEC filing
  2. IONSIonis Pharmaceuticals · zilganersen · Alexander diseaseNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: in Q1 2026

    Planned NDA submission in Q1 2026Details

    IONIS PHARMACEUTICALS INC (IONS) · zilganersen · Alexander disease

    Stage: Not stated

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

    Period the company stated: in Q1 2026

    Planned NDA submission in Q1 2026

    SEC Form 8-K · Filed: · Accession: 0001140361-26-000893 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “NDA submission planned in Q1 2026” · SEC filing

Window ends in: Q2 2026

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

  1. MIRMMirum Pharmaceuticals · volixibatTopline/data readout MatchedSEC ↗Watch

    Period the company stated: Q2 2026

    PSC topline data expected Q2 2026Details

    Mirum Pharmaceuticals, Inc. (MIRM) · volixibat

    Stage: Not stated

    Public float (as of ): $2.3B (SEC filing) · Over $2B

    Period the company stated: Q2 2026

    Volixibat VISTAS study in PSC topline data expected Q2 2026

    SEC Form EX-99.1 · Filed: · Accession: 0001759425-26-000010 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “VISTAS study in primary sclerosing cholangitis (PSC) topline data expected Q2 2026” · SEC filing

Window ends in: Q3 2026

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

  1. ARGXargenx · efgartigimodTopline/data readout MatchedSEC ↗Watch

    Period the company stated: third quarter of 2026

    (myositis) expected in third quarter of 2026Details

    ARGENX SE (ARGX) · efgartigimod

    Stage: Not stated

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

    Period the company stated: third quarter of 2026

    Topline results from ALKIVIA study (myositis) expected in third quarter of 2026

    SEC Form EX-99.1 · Filed: · Accession: 0001628280-26-031739 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “topline results expected in second half of 2026” · SEC filing
  2. MIRMMirum Pharmaceuticals · brelovitugTopline/data readout MatchedSEC ↗Watch

    Period the company stated: Q3 and Q4 2026

    results expected in Q3 and Q4 2026, respectively.Details

    Mirum Pharmaceuticals, Inc. (MIRM) · brelovitug

    Stage: Phase 3SEC filing · “Phase 3”

    Public float (as of ): $2.3B (SEC filing) · Over $2B

    Period the company stated: Q3 and Q4 2026

    Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.

    SEC Form EX-99.1 · Filed: · Accession: 0001759425-26-000044 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (2)
    1. · “Completed enrollment in brelovitug AZURE-1 and AZURE-4 Phase 3 studies in HDV; topline results expected in H2 2026.” · SEC filing
    2. · “AZURE-1 and AZURE-4 studies in HDV topline data expected H2 2026” · SEC filing
  3. VKTXViking Therapeutics · VK2735Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 3Q26

    Dosing Study Data Expected 3Q26Details

    Viking Therapeutics, Inc. (VKTX) · VK2735

    Stage: Not stated

    Public float (as of ): $2.9B (SEC filing) · Over $2B

    Period the company stated: 3Q26

    Maintenance Dosing Study Data Expected 3Q26

    SEC Form EX-99.1 · Filed: · Accession: 0001193125-26-323652 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (2)
    1. · “Maintenance Dosing Study Advances; Data Expected 3Q26” · SEC filing
    2. · “Phase 1 Maintenance Dosing Study Fully Enrolled; Data Expected 3Q26” · SEC filing

Window ends in: Q4 2026

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

  1. ACADAcadia Pharmaceuticals · remlifanserinTopline/data readout MatchedSEC ↗Watch

    Period the company stated: August to October 2026

    study remains on track for August to October 2026Details

    ACADIA PHARMACEUTICALS INC (ACAD) · remlifanserin

    Stage: Phase 2SEC filing · “Phase 2”

    Public float (as of ): $2.3B (SEC filing) · Over $2B

    Period the company stated: August to October 2026

    Phase 2 topline results readout from the remlifanserin Alzheimer’s disease psychosis study remains on track for August to October 2026

    SEC Form EX-99.1 · Filed: · Accession: 0001193125-26-209253 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (1)
    1. · “Phase 2 top-line results readout from the remlifanserin Alzheimer’s disease psychosis study remains on track for August to October 2026” · SEC filing
  2. RAREUltragenyx Pharmaceutical · GTX-102Topline/data readout MatchedSEC ↗Watch

    Period the company stated: September or October 2026

    study are expected in the September or October 2026Details

    Ultragenyx Pharmaceutical Inc. (RARE) · GTX-102

    Stage: Not stated

    Public float (as of ): $3.4B (SEC filing) · Over $2B

    Period the company stated: September or October 2026

    Data from this study are expected in the September or October 2026

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-333233 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (3)
    1. · “Data from the fully enrolled, pivotal, Phase 3 Aspire study in patients with a genetically confirmed diagnosis of UBE3A deletion is expected in the second half of 2026” · SEC filing
    2. · “Data from the fully enrolled, pivotal, Phase 3 Aspire study in patients with a genetically confirmed 1 diagnosis of UBE3A deletion is expected in the second half of 2026” · SEC filing
    3. · “Phase 3 Aspire study fully enrolled; Phase 3 data expected in the second half of 2026” · SEC filing
  3. MIRMMirum Pharmaceuticals · maralixibatTopline/data readout MatchedSEC ↗Watch

    Period the company stated: Q4 2026

    results expected in Q4 2026Details

    Mirum Pharmaceuticals, Inc. (MIRM) · maralixibat

    Stage: Phase 3SEC filing · “Phase 3”

    Public float (as of ): $2.3B (SEC filing) · Over $2B

    Period the company stated: Q4 2026

    EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026

    SEC Form EX-99.1 · Filed: · Accession: 0001759425-26-000044 · Last checked: · Matched

    Company reported on (SEC filing)

    Earlier SEC statements (4)
    1. · “EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026” · SEC filing
    2. · “EXPAND study in additional cholestatic pruritus settings topline data expected Q4 2026” · SEC filing
    3. · “LIVMARLI ® EXPAND study in additional cholestatic pruritus settings timing accelerated; topline data now expected Q4 2026” · SEC filing
    4. · “top-line data from the Phase 3 Livmarli EXPAND clinical trial for the treatment of other ultra-rare cholestatic pruritus indications, the Phase 2b volixibat clinical trial for the treatment of primary biliary cholangitis and the Phase 2 clinical trial of MRM-3379 for the treatment of Fragile-X Syndrome in 2027” · SEC filing

Window ends in: H2 2025

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

  1. VKTXViking Therapeutics · VK2735Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H25

    Enrolled; Data Expected in 2H25Details

    Viking Therapeutics, Inc. (VKTX) · VK2735

    Stage: Phase 2SEC filing · “Phase 2”

    Public float (as of ): $2.9B (SEC filing) · Over $2B

    Period the company stated: 2H25

    Phase 2 VENTURE-Oral Dosing Trial in Obesity Fully Enrolled; Data Expected in 2H25

    SEC Form EX-99.1 · Filed: · Accession: 0000950170-25-057337 · Last checked: · Matched

    Resolution filing (SEC filing)

Window ends in: H2 2026

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

  1. QTTBQ32 Bio · bempikibartTopline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    medical conference in the second half of 2026Details

    Q32 Bio Inc. (QTTB) · bempikibart

    Stage: Not stated

    Public float (as of ): $10M (SEC filing) · Under $500M

    Period the company stated: second half of 2026

    additional details from 36-week results and initial findings from 52-week results to be presented at a medical conference in the second half of 2026

    SEC Form 8-K · Filed: · Accession: 0001193125-26-333813 · Last checked: · Matched

    Resolution filing (SEC filing)

  2. ROIVRoivant Sciences · mosliciguatTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    interstitial lung disease 2H 2026Details

    Roivant Sciences Ltd. (ROIV) · mosliciguat

    Stage: Phase 2SEC filing · “Phase 2”

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

    Period the company stated: 2H 2026

    Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026

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

    Resolution filing (SEC filing)

    Earlier SEC statements (10)
    1. · “Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026” · SEC filing
    2. · “Phase 2 PHocus study of mosliciguat in 135 patients with pulmonary hypertension associated with interstitial lung disease ( “ PH-ILD); topline data expected in the second half of calendar year 2026.” · SEC filing
    3. · “Phase 2 PHocus study of mosliciguat in 135 patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD); topline data expected in the second half of calendar year 2026.” · SEC filing
    4. · “Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026” · SEC filing
    5. · “Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease fully enrolled, with topline data expected in the second half of calendar year 2026.” · SEC filing
    6. · “Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026” · SEC filing
    7. · “Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026” · SEC filing
    8. · “Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026” · SEC filing
    9. · “Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026” · SEC filing
    10. · “Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026” · SEC filing

Window ends in: 2025

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

  1. IONSIonis Pharmaceuticals · olezarsen · severe hypertriglyceridemiaNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: by the end of the year

    and 80 mg doses to the FDA by the end of the year.Details

    IONIS PHARMACEUTICALS INC (IONS) · olezarsen · severe hypertriglyceridemia

    Stage: Phase 3SEC filing · “Phase 3”

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

    Period the company stated: by the end of the year

    Ionis is on track to submit a supplemental new drug application for both the 50 mg and 80 mg doses to the FDA by the end of the year.

    ClinicalTrials.gov NCT05079919 · NCT stated in SEC filing

    ClinicalTrials.gov NCT05552326 · NCT stated in SEC filing

    SEC Form 8-K · Filed: · Accession: 0001140361-25-041225 · Last checked: · Matched

    Resolution filing (SEC filing)

    Earlier SEC statements (7)
    1. · “We are on track to submit a supplemental new drug application for both the 50 mg and 80 mg doses to the U.S. Food and Drug Administration (“FDA”) by the end of the year” · SEC filing
    2. · “sNDA submission on track for the end of 2025” · SEC filing
    3. · “sNDA submission on track by year-end” · SEC filing
    4. · “sNDA submission planned by end of year” · SEC filing
    5. · “Ionis plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration by end of year.” · SEC filing
    6. · “We plan to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration by end of year.” · SEC filing
    7. · “which will be the basis for our potential sNDA filing in sHTG by year-end.” · 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.