| 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 |