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KeptIndex

Commitment calendars · as of 2026-10-27

Regulatory milestone calendar

Dated regulatory steps companies have announced: FDA submissions, approvals sought, licence applications and other filings, soonest first.

For biotech and healthcare investors following submission and decision timelines, and for analysts checking whether a company's regulatory dates have held before. Every entry links to its Kept ID page and the SEC filing it came from. An open commitment is a quote and a date, not a forecast: nothing here says a company will miss.

85open regulatory milestones on record
2due in the next 30 days
76%delivered on time in the past (n = 284)
39 dmedian delay when late (n = 12)

Base rate from confirmed outcomes only (checked by a person or by independent checks agreeing on primary evidence): 76% on time, 12% late or in part, 12% not delivered or withdrawn. 4% of all regulatory milestones on record had their date pushed later in a later filing. Commitments with no public record after the deadline are never counted as misses. Break it down by horizon in KeptBase.

October 2026 2

31 Oct 2026in 4 days Pg&E CorpPCG Submit the 2028-2031 Wildfire Mitigation PlanAnnounced 22 Oct 2026 · KI-C-2026-PCG-022869
31 Oct 2026in 4 days Uranium Energy Corp.UEC Submit final reports to the BLM for the Sweetwater projectAnnounced 29 Sep 2026 · KI-C-2026-UEC-001325

November 2026 1

30 Nov 2026in 34 days Prudential Financial Inc.PRU Submit business improvement plans to the FSA for PHJ, POJ and GibraltarAnnounced 9 Oct 2026 · KI-C-2026-PRU-005920

December 2026 50

31 Dec 2026in 65 days Adma Biologics, Inc.ADMA Submit pre-Investigational New Drug meeting package to the FDAAnnounced 5 Aug 2026 · KI-C-2026-ADMA-003445
31 Dec 2026in 65 days Adma Biologics, Inc.ADMA Submit FDA Pre-IND package for the SG-001 pipeline programAnnounced 12 Jan 2026 · KI-C-2026-ADMA-003440
31 Dec 2026in 65 days AEON Biopharma, Inc.AEON Submit an investigational new drug application for the CMAP pharmacodynamic studyAnnounced 30 Sep 2026 · KI-C-2026-AEON-001629
31 Dec 2026in 65 days Aldeyra Therapeutics, Inc.ALDX File an Investigational New Drug application for ADX-248Announced 28 Oct 2025 · KI-C-2025-ALDX-003570
31 Dec 2026in 65 days Aquestive Therapeutics, Inc.AQST Complete the New Drug Submission to Health Canada for AnaphylmAnnounced 15 Oct 2026 · KI-C-2026-AQST-011958
31 Dec 2026in 65 days Aquestive Therapeutics, Inc.AQST File Anaphylm in Canada for regulatory approvalAnnounced 17 Sep 2026 · KI-C-2026-AQST-000772
31 Dec 2026in 65 days Argenx SEARGX Submit sBLA for pediatric gMGAnnounced 22 Oct 2026 · KI-C-2026-ARGX-022938
31 Dec 2026in 65 days Argenx SEARGX Submit sBLA for VYVGART Hytrulo in IMNMAnnounced 22 Oct 2026 · KI-C-2026-ARGX-022932
31 Dec 2026in 65 days Beam Therapeutics Inc.BEAM Submit a BLA for risto-celAnnounced 12 Jan 2026 · KI-C-2026-BEAM-003316
31 Dec 2026in 65 days BioCardia, Inc.BCDA Submit Shonin pre-market regulatory application to Japan's PMDAAnnounced 23 Sep 2026 · KI-C-2026-BCDA-000358
31 Dec 2026in 65 days BioCardia, Inc.BCDA Submit Shonin pre-market regulatory submission to Japan's PMDA for CardiAMP Cell Therapy approvalAnnounced 10 Sep 2026 · KI-C-2026-BCDA-000633
31 Dec 2026in 65 days BridgeBio Pharma, Inc.BBIO Submit a Marketing Authorization Application for oral infigratinib to the European Medicines AgencyAnnounced 13 Oct 2026 · KI-C-2026-BBIO-009608
31 Dec 2026in 65 days Bristol Myers Squibb Co.BMY · S&P 500 Report Phase 3 data readout for Alzheimer's psychosis (KarXT/Cobenfy) in 2026Announced 31 Oct 2024 · KI-C-2024-BMY-005865
31 Dec 2026in 65 days Candel Therapeutics, Inc.CADL File BLA for aglatimagene besadenovec in prostate cancerAnnounced 9 Sep 2026 · KI-C-2026-CADL-000585
31 Dec 2026in 65 days Candel Therapeutics, Inc.CADL Submit Biologics License Application for aglatimagene besadenovecAnnounced 10 Sep 2026 · KI-C-2026-CADL-000641
31 Dec 2026in 65 days Century Therapeutics, Inc.IPSC Submit IND application for CNTY-813 iPSC-derived islet replacement therapyAnnounced 9 Sep 2026 · KI-C-2026-IPSC-000537
31 Dec 2026in 65 days Century Therapeutics, Inc.IPSC Submit the Investigational New Drug application for CNTY-813Announced 2 Oct 2026 · KI-C-2026-IPSC-004380
31 Dec 2026in 65 days CMS EnergyCMS File the next Integrated Resource PlanAnnounced 31 Oct 2024 · KI-C-2024-CMS-010721
31 Dec 2026in 65 days Cullinan Therapeutics, Inc.CGEM Complete the New Drug Application submission for zipalertinib plus chemotherapyAnnounced 2 Oct 2026 · KI-C-2026-CGEM-004382
31 Dec 2026in 65 days Disc Medicine, Inc.IRON Resubmit an NDA for bitopertin to the FDAAnnounced 19 Oct 2026 · KI-C-2026-IRON-017646
31 Dec 2026in 65 days Disc Medicine, Inc.IRON Resubmit a New Drug Application to the FDAAnnounced 19 Oct 2026 · KI-C-2026-IRON-017645
31 Dec 2026in 65 days enGene Therapeutics Inc.ENGN Initiate Biologics License Application submission for detalimogeneAnnounced 8 Sep 2026 · KI-C-2026-ENGNW-000466
31 Dec 2026in 65 days enGene Therapeutics Inc.ENGN Report data update on key regulatory endpoints and complete response rates from LEGEND pivotal cohortAnnounced 8 Sep 2026 · KI-C-2026-ENGNW-000516
31 Dec 2026in 65 days Generation Bio Co. Submit first IND application for ctLNP-siRNA therapeuticAnnounced 6 Jan 2025 · KI-C-2025-C733294-000044
31 Dec 2026in 65 days Hawaiian Electric Co. Inc. File cost deferral application for Hurricane Lala and Kona Low storm costsAnnounced 8 Sep 2026 · KI-C-2026-C046207-000454
31 Dec 2026in 65 days Hepion Pharmaceuticals, Inc.HEPA File New Drug Application for NASHAnnounced 28 Jan 2021 · KI-C-2021-HEPA-022563
31 Dec 2026in 65 days iBio, Inc.IBIO File IND equivalent for IBIO-610 Activin E antibodyAnnounced 14 Sep 2026 · KI-C-2026-IBIO-000679
31 Dec 2026in 65 days ImmunityBio, Inc.IBRX Submit BLA for ANKTIVA in BCG naïve NMIBC patientsAnnounced 14 Jan 2026 · KI-C-2026-IBRX-002827
31 Dec 2026in 65 days ImmunityBio, Inc.IBRX Submit supplemental Biologics License Application for the Phase 2B QUILT-2.005 trialAnnounced 4 Aug 2026 · KI-C-2026-IBRX-002828
31 Dec 2026in 65 days Inmune Bio, Inc.INMB Submit a marketing authorisation application for Ebstrocel to the UK MHRAAnnounced 21 Oct 2026 · KI-C-2026-INMB-019859
31 Dec 2026in 65 days Inmune Bio, Inc.INMB Submit Marketing Authorization Application to UK MHRA for CORDStrom platformAnnounced 14 Sep 2026 · KI-C-2026-INMB-000711
31 Dec 2026in 65 days Jasper Therapeutics, Inc.JSPR Report initial interim data from the IgAN basket study of vensobafusp alfaAnnounced 15 Oct 2026 · KI-C-2026-JSPR-011967
31 Dec 2026in 65 days Kodiak Sciences Inc.KOD Submit the biologics license application for ZenkudaAnnounced 28 Sep 2026 · KI-C-2026-KOD-000899
31 Dec 2026in 65 days Kyverna Therapeutics, Inc.KYTX Complete the rolling Biologics License Application submissionAnnounced 24 Sep 2026 · KI-C-2026-KYTX-000536
31 Dec 2026in 65 days Mako Mining Corp.MAKO Submit the final ESIA for the Eagle Mountain Gold ProjectAnnounced 19 Oct 2026 · KI-C-2026-MAKO-017719
31 Dec 2026in 65 days Metagenomi Therapeutics, Inc.MGX Submit IND for first-in-human Phase 1/2 studyAnnounced 22 Sep 2026 · KI-C-2026-MGX-000117
31 Dec 2026in 65 days ModernaMRNA Submit mRNA-1010 regulatory applications in additional countriesAnnounced 11 Feb 2026 · KI-C-2026-MRNA-006260
31 Dec 2026in 65 days NeuroSense Therapeutics Ltd.NRSN Submit New Drug Submission to Health Canada for PrimeC in ALSAnnounced 13 Oct 2026 · KI-C-2026-NRSN-010751
31 Dec 2026in 65 days Odyssey Therapeutics, Inc.ODTX Submit a Clinical Trial Application for OD-002Announced 20 Oct 2026 · KI-C-2026-ODTX-019197
31 Dec 2026in 65 days Odyssey Therapeutics, Inc.ODTX File CTA for OD-002Announced 9 Sep 2026 · KI-C-2026-ODTX-000548
31 Dec 2026in 65 days Oragenics Inc.OGEN Submit investigational new drug application for ONP-002Announced 16 Sep 2026 · KI-C-2026-OGEN-000762
31 Dec 2026in 65 days OS Therapies IncOSTX Submit Conditional Marketing Authorization Application to the MHRAAnnounced 5 Oct 2026 · KI-C-2026-OSTX-004912
31 Dec 2026in 65 days OS Therapies IncOSTX Submit Biologics License Application to the FDAAnnounced 5 Oct 2026 · KI-C-2026-OSTX-004913
31 Dec 2026in 65 days PMGC Holdings Inc.ELAB File IND application for EL-22Announced 7 Feb 2025 · KI-C-2025-ELAB-000390
31 Dec 2026in 65 days PPL CorporationPPL File a CPCN request with regulators to build additional generation in KentuckyAnnounced 7 Aug 2026 · KI-C-2026-PPL-011812
31 Dec 2026in 65 days PTC Therapeutics, Inc.PTCT Complete the BLA submission for ST-920Announced 21 Sep 2026 · KI-C-2026-PTCT-000088
31 Dec 2026in 65 days Rafael Holdings, Inc.RFL Submit an NDA for Trappsol® Cyclo™Announced 30 Sep 2026 · KI-C-2026-RFL-001655
31 Dec 2026in 65 days Sana Biotechnology, Inc.SANA File SC451 IND and begin Phase 1/2 trialAnnounced 8 Sep 2026 · KI-C-2026-SANA-000443
31 Dec 2026in 65 days Spyre Therapeutics, Inc.SYRE Report topline data from SKYWAY trial in psoriatic arthritis and axial spondyloarthritisAnnounced 8 Sep 2026 · KI-C-2026-SYRE-000522
31 Dec 2026in 65 days Vertex PharmaceuticalsVRTX Submit global regulatory applications for zimislecel in type 1 diabetesAnnounced 4 Aug 2025 · KI-C-2025-VRTX-006549

February 2027 1

28 Feb 2027in 124 days Inmune Bio, Inc.INMB Finalize and submit a complete Marketing Authorisation Application to the UK MHRA for EbstrocelAnnounced 21 Oct 2026 · KI-C-2026-INMB-019861

March 2027 3

31 Mar 2027in 155 days BlossomHill Therapeutics, Inc.BLSM Submit investigational new drug application for BH-501284Announced 18 Sep 2026 · KI-C-2026-BLSM-000811
31 Mar 2027in 155 days Mira Pharmaceuticals, Inc.MIRA Submit an Investigational New Drug (IND) application for MIRA-55Announced 22 Oct 2026 · KI-C-2026-MIRA-022860
31 Mar 2027in 155 days Ocugen, Inc.OCGN Report topline data from the Phase 3 liMeliGhT trial of OCU400Announced 15 Oct 2026 · KI-C-2026-OCGN-011975

June 2027 10

30 Jun 2027in 246 days 60 Degrees Pharmaceuticals, Inc.SXTP File sNDA for babesiosisAnnounced 6 Oct 2026 · KI-C-2026-SXTP-005064
30 Jun 2027in 246 days Acumen Pharmaceuticals, Inc.ABOS File an IND application for an EBD candidate to treat Alzheimer's DiseaseAnnounced 16 Sep 2026 · KI-C-2026-ABOS-000761
30 Jun 2027in 246 days Acumen Pharmaceuticals, Inc.ABOS Submit an IND filing for a lead clinical candidate in the Enhanced Brain Delivery programAnnounced 26 Oct 2026 · KI-C-2026-ABOS-025281
30 Jun 2027in 246 days Cartesian Therapeutics, Inc.RNAC Submit a biologics license application for Descartes-08Announced 29 Sep 2026 · KI-C-2026-RNAC-001292
30 Jun 2027in 246 days Definium Therapeutics, Inc.DFTX File NDA for DT120 ODT with FDAAnnounced 14 Sep 2026 · KI-C-2026-DFTX-000683
30 Jun 2027in 246 days Disc Medicine, Inc.IRON Submit CRL response for bitopertinAnnounced 30 Jul 2026 · KI-C-2026-IRON-002239
30 Jun 2027in 246 days Disc Medicine, Inc.IRON Submit a response to the FDA's Complete Response Letter for bitopertinAnnounced 26 Feb 2026 · KI-C-2026-IRON-002230
30 Jun 2027in 246 days Immix Biopharma, Inc.IMMX Complete the NEXICART-2 final readout and submit the BLAAnnounced 29 Sep 2026 · KI-C-2026-IMMX-001298
30 Jun 2027in 246 days Inmune Bio, Inc.INMB Submit a Biologics License Application to the U.S. FDA for EbstrocelAnnounced 21 Oct 2026 · KI-C-2026-INMB-019862
30 Jun 2027in 246 days Korro Bio, Inc.KRRO Submit regulatory application for KRRO-111Announced 22 Oct 2026 · KI-C-2026-KRRO-020958

September 2027 1

30 Sep 2027in 338 days Dyne Therapeutics, Inc.DYN Submit a Biologics License Application for U.S. Accelerated ApprovalAnnounced 29 Sep 2026 · KI-C-2026-DYN-001295

December 2027 12

31 Dec 2027in 430 days 60 Degrees Pharmaceuticals, Inc.SXTP Submit a supplemental New Drug Application for tafenoquineAnnounced 23 Oct 2026 · KI-C-2026-SXTP-022888
31 Dec 2027in 430 days Abeona Therapeutics Inc.ABEO File an Investigational New Drug application and commence first-in-human studies for ABO-701Announced 13 May 2026 · KI-C-2026-ABEO-003407
31 Dec 2027in 430 days Alaunos Therapeutics, Inc.TCRT Submit IND or CTA for VLR199Announced 13 Oct 2026 · KI-C-2026-TCRT-009602
31 Dec 2027in 430 days Celldex Therapeutics, Inc.CLDX Submit a Biologics License Application to the FDA for barzolvolimabAnnounced 22 Sep 2026 · KI-C-2026-CLDX-000102
31 Dec 2027in 430 days Collective Mining Ltd.CNL Submit the environmental license application for the Apollo depositAnnounced 13 Oct 2026 · KI-C-2026-CNL-010738
31 Dec 2027in 430 days Deep Fission, Inc.FISN Submit multi-reactor license applicationAnnounced 20 Oct 2026 · KI-C-2026-FISN-019174
31 Dec 2027in 430 days Inmune Bio, Inc.INMB Submit a marketing authorisation application for Ebstrocel to the EU EMAAnnounced 21 Oct 2026 · KI-C-2026-INMB-019860
31 Dec 2027in 430 days Lexeo Therapeutics, Inc.LXEO Submit an IND for the next Friedreich ataxia development candidateAnnounced 22 Sep 2026 · KI-C-2026-LXEO-000113
31 Dec 2027in 430 days Novonix LtdNVX Obtain ISO 14001 certificationAnnounced 19 Oct 2026 · KI-C-2026-NVX-017721
31 Dec 2027in 430 days Ocugen, Inc.OCGN Submit biologics license application for OCU410ST (Stargardt disease)Announced 8 Sep 2026 · KI-C-2026-OCGN-000444
31 Dec 2027in 430 days Ocugen, Inc.OCGN Submit biologics license application for OCU400 (retinitis pigmentosa)Announced 8 Sep 2026 · KI-C-2026-OCGN-000450
31 Dec 2027in 430 days Spyre Therapeutics, Inc.SYRE Report topline induction data from SKYLINE Part B trialAnnounced 8 Sep 2026 · KI-C-2026-SYRE-000451

June 2028 2

30 Jun 2028in 612 days Alaunos Therapeutics, Inc.TCRT Submit IND or CTA for VLR247Announced 13 Oct 2026 · KI-C-2026-TCRT-009604
30 Jun 2028in 612 days Vaxcyte, Inc.PCVX Submit Biologics License Application for VAX-31Announced 5 Oct 2026 · KI-C-2026-PCVX-004923

December 2028 3

31 Dec 2028in 796 days Corbus Pharmaceuticals Holdings, Inc.CRBP Submit a potential BLA for CRB-701 in second-line OPSCCAnnounced 15 Oct 2026 · KI-C-2026-CRBP-011965
31 Dec 2028in 796 days Ocugen, Inc.OCGN Submit three Biologics License Applications for Ocugen gene therapy candidatesAnnounced 15 Oct 2026 · KI-C-2026-OCGN-011976
31 Dec 2028in 796 days Ocugen, Inc.OCGN Submit biologics license application for OCU410 (geographic atrophy)Announced 8 Sep 2026 · KI-C-2026-OCGN-000468

The Deadline Report

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