ORION Biotech Catalyst Calendar
Menu

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.

All stages · All sizes · All periods

Filters

Stage
Event type
Company size (public float)
Period

Optional; keeps the company’s stated period precision.

250 programs as of

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

Window ends in: H2 2026

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

  1. CHRSCoherus Oncology · tagmokitug + toripalimabTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    initial data expected in 2H 2026.Details

    Coherus Oncology, Inc. (CHRS) · tagmokitug + toripalimab

    Stage: OtherSEC filing · “Phase 1b/2a”

    Public float (as of ): $81M (SEC filing) · Under $500M

    Period the company stated: 2H 2026

    The Phase 1b/2a study evaluating the tagmokitug and toripalimab combination in fourth-line and beyond colorectal cancer with no liver metastasis, is fully enrolled, with initial data expected in 2H 2026.

    SEC Form 8-K · Filed: · Accession: 0001104659-26-091188 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “● A Phase 1b/2a study evaluating tagmokitug/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026 .” · SEC filing
  2. CHRSCoherus Oncology · tagmokitug + toripalimab +/− chemotherapyTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    initial data expected in 2H 2026.Details

    Coherus Oncology, Inc. (CHRS) · tagmokitug + toripalimab +/− chemotherapy

    Stage: Not stated

    Public float (as of ): $81M (SEC filing) · Under $500M

    Period the company stated: 2H 2026

    esophageal squamous cell carcinoma (ESCC), continues to enroll patients, with initial data expected in 2H 2026.

    SEC Form 8-K · Filed: · Accession: 0001104659-26-091188 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “data readout expected in 2H 2026.” · SEC filing
  3. CRBUCaribou Biosciences · CB-011Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    In the second half of 2026, Caribou expects to report initial safety and efficacy from doseDetails

    Caribou Biosciences, Inc. (CRBU) · CB-011

    Stage: Phase 1SEC filing · “phase 1”

    Public float (as of ): $112M (SEC filing) · Under $500M

    Period the company stated: second half of 2026

    In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up, as well as longer follow-up data on the 12-patient, BCMA-naïve RDE cohort from dose escalation.

    ClinicalTrials.gov NCT05722418 · NCT stated in SEC filing

    SEC Form 8-K · Filed: · Accession: 0001619856-26-000053 · Last checked: · Matched

  4. CRBUCaribou Biosciences · CB-011Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    In the second half of 2026, Caribou expects to report initial safety and efficacy from doseDetails

    Caribou Biosciences, Inc. (CRBU) · CB-011

    Stage: Phase 1SEC filing · “phase 1”

    Public float (as of ): $112M (SEC filing) · Under $500M

    Period the company stated: second half of 2026

    In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up

    ClinicalTrials.gov NCT05722418 · NCT stated in SEC filing

    SEC Form 8-K · Filed: · Accession: 0001619856-26-000053 · Last checked: · Matched

  5. DBVTDBV Technologies · Viaskin Peanut patchNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    a BLA submission in the second half of 2026 for children ages one to three.Details

    DBV Technologies S.A. (DBVT) · Viaskin Peanut patch

    Stage: Not stated

    Public float (as of ): $250M (SEC filing) · Under $500M

    Period the company stated: second half of 2026

    the Company is planning for a BLA submission in the second half of 2026 for children ages one to three.

    SEC Form 10-Q · Filed: · Accession: 0001628280-26-048453 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “Conditional on successful completion of this safety study, the Company plans a BLA submission in the second half of 2026 for children ages one to three.” · SEC filing
  6. ERASErasca · ERAS-4001Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    BOREALIS-1 trial in the second half of 2026.Details

    Erasca, Inc. (ERAS) · ERAS-4001

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $316M (SEC filing) · Under $500M

    Period the company stated: second half of 2026

    We anticipate a Phase 1 monotherapy data readout from the BOREALIS-1 trial in the second half of 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-344611 · Last checked: · Matched

    Earlier SEC statements (4)
    1. · “We anticipate a Phase 1 monotherapy data readout from the BOREALIS-1 trial in the second half of 2026.” · SEC filing
    2. · “ERAS-4001 is progressing through Phase 1 dose escalation, with preliminary safety, tolerability, pharmacokinetics, and early efficacy data expected in the second half of 2026.” · SEC filing
    3. · “We anticipate a Phase 1 monotherapy data readout from the BOREALIS-1 trial in the second half of 2026.” · SEC filing
    4. · “We anticipate a Phase 1 monotherapy data readout in the second half of 2026.” · SEC filing
  7. EXELExelixis · zanzalintinibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: Second Half of 2026

    Pivotal Trial Expected in Second Half of 2026Details

    EXELIXIS, INC. (EXEL) · zanzalintinib

    Stage: Phase 3SEC filing · “Phase 3”

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

    Period the company stated: Second Half of 2026

    Topline Results for Phase 3 STELLAR-304 Pivotal Trial Expected in Second Half of 2026

    SEC Form EX-99.1 · Filed: · Accession: 0000939767-26-000096 · Last checked: · Matched

  8. HUMAHumacyte · acellular tissue engineered vessel / ATEVNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    for hemodialysis in the second half of 2026.Details

    Humacyte, Inc. (HUMA) · acellular tissue engineered vessel / ATEV

    Stage: Not stated

    Public float (as of ): $280M (SEC filing) · Under $500M

    Period the company stated: second half of 2026

    We plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-347022 · Last checked: · Matched

    Earlier SEC statements (9)
    1. · “Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026.” · SEC filing
    2. · “If the interim results from our ongoing V012 Phase 3 trial in women are positive, we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
    3. · “we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
    4. · “we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
    5. · “If the interim results from our ongoing V012 Phase 3 trial in women are positive, we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
    6. · “we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
    7. · “we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
    8. · “we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
    9. · “we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026.” · SEC filing
  9. INABIN8bio · INB-619Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    data for INB-619 in the second half of 2026.Details

    IN8BIO, INC. (INAB) · INB-619

    Stage: Not stated

    Public float (as of ): $7M (SEC filing) · Under $500M

    Period the company stated: second half of 2026

    We expect to report initial in vivo data for INB-619 in the second half of 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-338012 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “Progressing INB-619 into IND-enabling studies, with initial animal data expected in 2026.” · SEC filing
    2. · “Initial TCE preclinical animal data and additional IND-enabling data for INB-619 in 2H26.” · SEC filing
  10. INCYIncyte · INCA033989Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    are anticipated in the second half of 2026Details

    INCYTE CORP (INCY) · INCA033989

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $11.2B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026

    SEC Form EX-99.1 · Filed: · Accession: 0000879169-26-000053 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “Data from the cohort evaluating INCA033989 and INCA033989 in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026” · SEC filing
  11. INCYIncyte · INCA33890Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    is anticipated in the second half of 2026Details

    INCYTE CORP (INCY) · INCA33890

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $11.2B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    Additional data from the ongoing Phase 1 study evaluating INCA33890 in combination with bevacizumab and/or chemotherapy in patients with solid tumors is anticipated in the second half of 2026

    SEC Form 10-Q · Filed: · Accession: 0000879169-26-000056 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “Additional data from the ongoing Phase 1 study evaluating INCA33890 in combination with bevacizumab and/or chemotherapy in patients with solid tumors is expected in the second half of 2026” · SEC filing
    2. · “Additional data from the ongoing Phase 1 study evaluating INCA33890 in combination with bevacizumab and/or chemotherapy in patients with solid tumors is expected in the second half of 2026” · SEC filing
  12. INCYIncyte · INCB160058Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    are anticipated in the second half of 2026Details

    INCYTE CORP (INCY) · INCB160058

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $11.2B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    Results from the Phase 1 trial evaluating INCB160058 in MPN patients with a JAK2V617F mutation are anticipated in the second half of 2026

    SEC Form 10-Q · Filed: · Accession: 0000879169-26-000026 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “Results from the Phase 1 trial evaluating INCB160058 in MPN patients with a JAK2V617F mutation are anticipated in the second half of 2026” · SEC filing
  13. INCYIncyte · axatilimab + ruxolitinibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    results anticipated in the second half of 2026Details

    INCYTE CORP (INCY) · axatilimab + ruxolitinib

    Stage: Not stated

    Public float (as of ): $11.2B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    ruxolitinib in patients with newly diagnosed chronic GVHD is ongoing, with results anticipated in the second half of 2026

    SEC Form 10-Q · Filed: · Accession: 0000879169-26-000056 · Last checked: · Matched

    Earlier SEC statements (3)
    1. · “ruxolitinib in patients with newly diagnosed chronic GVHD is ongoing, with results anticipated in the second half of 2026” · SEC filing
    2. · “Data from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are anticipated in the second half of 2026” · SEC filing
    3. · “ruxolitinib in patients with newly diagnosed chronic GVHD is ongoing, with results anticipated in early 2027” · SEC filing
  14. INCYIncyte · povorcitinibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    are anticipated in the second half of 2026Details

    INCYTE CORP (INCY) · povorcitinib

    Stage: Phase 2SEC filing · “Phase 2”

    Public float (as of ): $11.2B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026

    SEC Form EX-99.1 · Filed: · Accession: 0000879169-26-000053 · Last checked: · Matched

    Earlier SEC statements (8)
    1. · “data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026” · SEC filing
    2. · “data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026” · SEC filing
    3. · “data from the Phase 2 proof-of-concept trial in asthma, are anticipated in 2026” · SEC filing
    4. · “data in asthma are anticipated in the second half of 2025” · SEC filing
    5. · “data in asthma are anticipated in the second half of 2025” · SEC filing
    6. · “data in asthma are anticipated in the second half of 2025” · SEC filing
    7. · “data in asthma are anticipated in the second half of 2025” · SEC filing
    8. · “data in asthma are anticipated in the second half of 2025” · SEC filing
  15. INCYIncyte · povorcitinibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    STOP-V1 and STOP-V2 in the second half of 2026Details

    INCYTE CORP (INCY) · povorcitinib

    Stage: Not stated

    Public float (as of ): $11.2B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    additional data from STOP-V1 and STOP-V2 in the second half of 2026

    SEC Form 10-Q · Filed: · Accession: 0000879169-26-000056 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “additional data from STOP-V1 and STOP-V2 in the second half of 2026” · SEC filing
  16. INCYIncyte · INCB161734 + chemotherapyTopline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    PDAC is anticipated in the second half of 2026.Details

    INCYTE CORP (INCY) · INCB161734 + chemotherapy

    Stage: Not stated

    Public float (as of ): $11.2B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    treatment in patients with metastatic PDAC is anticipated in the second half of 2026.

    SEC Form 10-Q · Filed: · Accession: 0000879169-26-000056 · Last checked: · Matched

  17. JANXJanux Therapeutics · JANX011Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    to be announced in the second half of 2026Details

    Janux Therapeutics, Inc. (JANX) · JANX011

    Stage: Phase 1SEC filing · “Phase 1”

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

    Period the company stated: second half of 2026

    Initial clinical data from the Phase 1 healthy volunteer study of JANX011 expected to be announced in the second half of 2026

    SEC Form EX-99.1 · Filed: · Accession: 0001193125-26-337977 · Last checked: · Matched

  18. KURAKura Oncology · darlifarnib + cabozantinibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    and cabozantinib in the second half of 2026Details

    Kura Oncology, Inc. (KURA) · darlifarnib + cabozantinib

    Stage: Phase 1SEC filing · “Phase 1a”

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

    Period the company stated: second half of 2026

    updated Phase 1a dose-escalation data from the combination of darlifarnib and cabozantinib in the second half of 2026

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-219481 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “updated Phase 1a dose-escalation data from the combination in the second half of 2026” · SEC filing
  19. KURAKura Oncology · ziftomenib + gilteritinibTopline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    preliminary data in the second half of 2026Details

    Kura Oncology, Inc. (KURA) · ziftomenib + gilteritinib

    Stage: Not stated

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

    Period the company stated: second half of 2026

    anticipate presenting preliminary data in the second half of 2026

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

    Earlier SEC statements (1)
    1. · “data from the KOMET-008 cohort evaluating ziftomenib in combination with gilteritinib in patients with relapsed or refractory NPM1-mutated AML in 2026” · SEC filing
  20. KURAKura Oncology · ziftomenib + quizartinib + 7+3Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    preliminary data in the second half of 2026Details

    Kura Oncology, Inc. (KURA) · ziftomenib + quizartinib + 7+3

    Stage: Not stated

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

    Period the company stated: second half of 2026

    anticipate presenting preliminary data in the second half of 2026

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

  21. KURAKura Oncology · ziftomenib + venetoclax + azacitidineTopline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    and MRD outcomes – 2H 2026Details

    Kura Oncology, Inc. (KURA) · ziftomenib + venetoclax + azacitidine

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

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

    Period the company stated: 2H 2026

    Updated long-term KOMET-007 Phase 1b data evaluating ziftomenib with venetoclax and azacitidine in newly diagnosed, intensive chemotherapy-ineligible NPM1 -m AML patients, including durability, survival, and MRD outcomes – 2H 2026

    SEC Form 8-K · Filed: · Accession: 0001193125-26-346856 · Last checked: · Matched

  22. LRMRLarimar Therapeutics · nomlabofuspNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    remaining modules in the second half of 2026Details

    Larimar Therapeutics, Inc. (LRMR) · nomlabofusp

    Stage: Not stated

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

    Period the company stated: second half of 2026

    We initiated our rolling BLA submission to the FDA for marketing approval of nomlabofusp using the accelerated approval pathway and expect to submit the remaining modules in the second half of 2026

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-331529 · Last checked: · Matched

    Earlier SEC statements (8)
    1. · “the remaining modules are expected to be submitted in the second half of 2026.” · SEC filing
    2. · “Submission of final modules for rolling BLA submission expected 2H 2026” · SEC filing
    3. · “We are continuing to focus on the completeness of our chemistry, manufacturing and controls ("CMC") module, and plan to submit the final modules, including the CMC module, in the second half of 2026.” · SEC filing
    4. · “plan to submit the CMC portion of the BLA in the second half of 2026” · SEC filing
    5. · “submission of the final modules including the CMC module expected in second half of 2026.” · SEC filing
    6. · “We are targeting nomlabofusp BLA submission in June 2026 seeking accelerated approval using tissue FXN levels as a novel surrogate endpoint.” · SEC filing
    7. · “We plan to submit a BLA seeking accelerated approval in the second quarter of 2026.” · SEC filing
    8. · “In the second quarter of 2026, we plan to submit a BLA seeking accelerated approval.” · SEC filing
  23. ORICORIC Pharmaceuticals · enozertinib / ORIC-114Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    to report data in the second half of 2026 in 1L NSCLC patients with EGFR exon 20 insertionDetails

    Oric Pharmaceuticals, Inc. (ORIC) · enozertinib / ORIC-114

    Stage: Not stated

    Public float (as of ): $862M (SEC filing) · $500M–$2B

    Period the company stated: second half of 2026

    We expect to report data in the second half of 2026 in 1L NSCLC patients with EGFR exon 20 insertion mutations as a monotherapy and in combination with SC amivantamab, as well as in 1L NSCLC patients with EGFR atypical mutations as a monotherapy.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-330631 · Last checked: · Matched

    Earlier SEC statements (1)
    1. · “We expect to report data in the second half of 2026 in 1L NSCLC patients with EGFR exon 20 insertion mutations as a monotherapy and in combination with SC amivantamab, as well as in 1L NSCLC patients with EGFR PACC mutations as a monotherapy.” · SEC filing
  24. ROIVRoivant Sciences · IMVT-1402Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    arthritis program 2H 2026Details

    Roivant Sciences Ltd. (ROIV) · IMVT-1402

    Stage: Not stated

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

    Period the company stated: 2H 2026

    Further updates from difficult-to-treat rheumatoid arthritis program 2H 2026

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

    Earlier SEC statements (2)
    1. · “Further updates from difficult-to-treat rheumatoid arthritis program 2H 2026” · SEC filing
    2. · “Immunovant will provide further updates on this program in the second half of calendar year 2026” · SEC filing
  25. ROIVRoivant Sciences · IMVT-1402Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    lupus erythematosus 2H 2026Details

    Roivant Sciences Ltd. (ROIV) · IMVT-1402

    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 cutaneous lupus erythematosus 2H 2026

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

    Earlier SEC statements (4)
    1. · “Topline data from Phase 2 trial in cutaneous lupus erythematosus 2H 2026” · SEC filing
    2. · “IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus (CLE) is fully enrolled, with topline data expected in the second half of calendar year 2026” · SEC filing
    3. · “Further updates on this program, as well as topline data from the fully enrolled proof-of-concept trial in cutaneous lupus erythematosus (CLE), are expected in the second half of calendar year 2026.” · SEC filing
    4. · “Topline data from Phase 2 trial in cutaneous lupus erythematosus 2H 2026” · SEC filing
  26. RXRXRecursion Pharmaceuticals · REC-1245Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H26

    data expected in 2H26Details

    RECURSION PHARMACEUTICALS, INC. (RXRX) · REC-1245

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $2.0B (SEC filing) · Over $2B

    Period the company stated: 2H26

    REC-1245 (RBM39): Additional Phase 1 dose escalation data expected in 2H26

    SEC Form 10-Q · Filed: · Accession: 0001601830-26-000098 · Last checked: · Matched

    Earlier SEC statements (2)
    1. · “REC-1245 (RBM39): Additional Phase 1 dose escalation data expected in 2H26” · SEC filing
    2. · “REC-1245 (RBM39): Additional Phase 1 dose escalation data expected in 2H26” · SEC filing
  27. SRPTSarepta Therapeutics · SRP-1001Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    FSHD remain on track for 2H 2026.Details

    Sarepta Therapeutics, Inc. (SRPT) · SRP-1001

    Stage: OtherSEC filing · “phase 1/2”

    Public float (as of ): $1.6B (SEC filing) · $500M–$2B

    Period the company stated: 2H 2026

    Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.

    SEC Form 8-K · Filed: · Accession: 0001193125-26-335056 · Last checked: · Matched

  28. SRPTSarepta Therapeutics · SRP-1003Topline/data readout MatchedSEC ↗Watch

    Period the company stated: 2H 2026

    FSHD remain on track for 2H 2026.Details

    Sarepta Therapeutics, Inc. (SRPT) · SRP-1003

    Stage: OtherSEC filing · “phase 1/2”

    Public float (as of ): $1.6B (SEC filing) · $500M–$2B

    Period the company stated: 2H 2026

    Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.

    SEC Form 8-K · Filed: · Accession: 0001193125-26-335056 · Last checked: · Matched

  29. SRRKScholar Rock Holding · SRK-439Topline/data readout MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    data anticipated in the second half of 2026.Details

    Scholar Rock Holding Corp (SRRK) · SRK-439

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $2.6B (SEC filing) · Over $2B

    Period the company stated: second half of 2026

    A Phase 1 study of SRK-439 in healthy volunteers is currently underway, with topline data anticipated in the second half of 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-336732 · Last checked: · Matched

    Earlier SEC statements (5)
    1. · “A Phase 1 study of SRK-439 in healthy volunteers is currently underway, with topline data anticipated in the second half of 2026.” · SEC filing
    2. · “A Phase 1 study evaluating SRK-439 in healthy volunteers is underway, with topline data expected in the second half of 2026.” · SEC filing
    3. · “A Phase 1 study of SRK-439 in healthy volunteers is currently underway, with topline data anticipated in the second half of 2026.” · SEC filing
    4. · “A Phase 1 study in healthy volunteers is underway, and topline data are expected in the second half of 2026.” · SEC filing
    5. · “A Phase 1 study evaluating SRK-439 in healthy volunteers is underway, with topline data expected in the second half of 2026.” · SEC filing
  30. TGTXTG Therapeutics · ublituximabNDA/BLA submission MatchedSEC ↗Watch

    Period the company stated: second half of 2026

    a supplemental BLA in the second half of 2026.Details

    TG THERAPEUTICS, INC. (TGTX) · ublituximab

    Stage: Not stated

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

    Period the company stated: second half of 2026

    with the goal of submitting a supplemental BLA in the second half of 2026.

    SEC Form 8-K · Filed: · Accession: 0001437749-26-018586 · Last checked: · Matched

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.

Add to Google Calendar Apple Calendar The subscription follows the filters chosen here. No sign-up; ORION stores nothing about subscribers.

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.

Want an email when one of these changes? Get a free Watch.

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.