Pipeline Watchlist
Company Pipelines
Companies
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- CAN-2409CAN-2409 / Adenovirus platform viral immunotherapy / OncologyBorderline resectable pancreatic adenocarcinomaPhase IIFast Track Designation (FDA); enrollment paused subject to additional fundingUSNSCLC + PD-1/PD-(L)1Phase IIFast Track Designation (FDA)USLocalized intermediate/high-risk prostate cancerBLA ReadinessFast Track Designation (FDA); Special Protocol Assessment (FDA)US
- CAN-3110CAN-3110 / HSV platform viral immunotherapy / OncologyRecurrent high-grade glioma / recurrent GBMPhase IFast Track Designation (FDA)US
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- BarzolvolimabCDX-0159 / KIT / KIT antagonist mAb / Immunology/inflammationChronic spontaneous urticariaPhase 3ongoingCold urticariaPhase 3ongoingSymptomatic dermographismPhase 3ongoing
- CDX-622CDX-622 / TSLP; SCF / Bispecific antibody / Immunology/inflammationHealthy volunteersPhase 1ongoingAsthma proof of mechanismPhase 1ongoing
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- COMP360COMP360 / synthetic psilocybin treatment / Mental healthTreatment-resistant depressionPhase 3NDA rolling submission underwayUSUKPost-traumatic stress disorderPhase 2b/3IND accepted; trial initiation enabledUSAnorexia nervosaPhase 2
- Prodrug programmeprodrug programme
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- CRB-701CRB-701 / Nectin-4 / antibody-drug conjugate / OncologyNectin-4 expressing solid tumorsPhase 3 pendingCSPC China: Phase 3 in cervical cancer milestoneChinaHNSCCPhase 1 in progressDose optimization; FDA Fast Track DesignationUSEuropeCervical cancerPhase 1 in progressDose optimization; FDA Fast Track DesignationUSEurope
- CRB-913CRB-913 / CB1R / peripherally restricted oral CB1 inverse agonist / Obesity/metabolic diseaseObesity and related conditionsPhase 1 in progress12-week dose-range study in obesity planned mid-2026
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- Vispacabtagene regedleucelCB-010 / vispa-cel / CD19 / Allogeneic anti-CD19 CAR-T cell therapy; PD-1 knockout / Hematologic malignanciesRelapsed or refractory B cell non-Hodgkin lymphomaPhase 1Ongoing
- CB-011CB-011 / BCMA / Allogeneic anti-BCMA CAR-T cell therapy; B2M knockout and B2M–HLA-E insertion / Hematologic malignanciesRelapsed or refractory multiple myelomaPhase 1Ongoing
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- VIASKIN® Peanut PatchDBV712 / Peanut allergen extract / Epicutaneous immunotherapy patch; drug-device combination / Food allergyPeanut allergy; children 4–7 years oldPhase 3 completed; BLA submission anticipated 1H 2026Primary endpoint met in VITESSE Phase 3USPeanut allergy; toddlers 1–3 years oldPhase 3 / BLA submission anticipated 2H 2026Accelerated Approval pathway; COMFORT Toddlers safety trial ongoingUSPeanut allergy; children 1–7 years oldMAA planningEMA guidance received for circular patchEU
- VIASKIN® Milk PatchDBV135 / Milk allergen / Epicutaneous immunotherapy patch; drug-device combination / Food allergy / immunologyCow’s milk allergy; ages 2–17 yearsPhase 2MILES study referencedMilk-induced eosinophilic esophagitis; ages 4–17 yearsPhase 2SMILEE study referenced
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- DT120 ODTDT120 / serotonin receptors / Orally disintegrating tablet formulation of lysergide (LSD) D-tartrate / Psychiatry / brain healthGeneralized anxiety disorderPhase 3Two Phase 3 registrational trials ongoing/evaluating efficacy and safetyU.S.EuropeMajor depressive disorderPhase 3Emerge Phase 3 ongoing; Ascend Phase 3 expected to initiate mid-2026U.S.
- DT402DT402 / serotonergic system / R-enantiomer of MDMA (R(-)-MDMA) / Neurodevelopmental disordersAutism spectrum disorderPhase 2aPhase 2a study initiated after completion of Phase 1 single-ascending dose study
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- DM199 (rinvecalinase alfa)DM199 / KLK1 / Recombinant human tissue kallikrein-1 protein (rhKLK1) / NeurologicalAcute Ischemic StrokePhase 2/3ReMEDy2 Study; in progress
- DM199 (rinvecalinase alfa)DM199 / KLK1 / Recombinant human tissue kallikrein-1 protein (rhKLK1) / Pregnancy ComplicationsPreeclampsiaPhase 2Part 1A Dose-Selection / Part 1B Expansion Cohort; in progressPreeclampsiaPhase 2Parts 2 & 3 Expected Management Study; in progressFetal Growth RestrictionPhase 2Part 3 Fetal Growth Restriction; in progress
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- ClaseprubartDNTH103 / active C1s / long-acting monoclonal antibody / autoimmune / neuromuscular disordersGeneralized Myasthenia Gravis (gMG)Phase IIPhase 2 data reported; Phase 3 trial planned mid-2026Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Phase IIICAPTIVATE; interim responder analysis completed and GO decision announced Q1 2026Multifocal Motor Neuropathy (MMN)Phase IITop-line Phase 2 data expected 2H 2026
- DNTH212DNTH212 / LBL-047 / BDCA2 and BAFF/APRIL / extended half-life bifunctional fusion protein / autoimmune disordersSystemic lupus erythematosus (SLE)Phase ITwo-part Phase 1 study in China ongoing; healthy-volunteer results expected 2H 2026China
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- PBGENE-HBVPBGENE-HBV / HBV cccDNA and integrated HBV DNA / in vivo ARCUS gene editing therapy / Infectious diseaseChronic hepatitis BPhase 1/2aELIMINATE-B trial ongoingGlobalUnited States
- PBGENE-DMDPBGENE-DMD / Dystrophin gene exons 45-55 region / in vivo ARCUS gene editing therapy / gene excision / Neuromuscular diseaseDuchenne muscular dystrophyPhase 1/2FUNCTION-DMD study; first clinical trial site activated and enrollment begun per company IR overviewUnited States
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- CDC Category A AgentCDC Category A agent / Medical countermeasuresUndisclosed Disease Area
- CDC Category B AgentCDC Category B agent / Medical countermeasuresUndisclosed Disease Area
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- EP-104GIEP-104GI / long-acting controlled-release fluticasone propionate formulation; intra-esophageal injection / Gastrointestinal / inflammatory diseaseEosinophilic esophagitis (EoE)Phase 1b/2Ongoing
- EP-104IAREP-104IAR / long-acting controlled-release fluticasone propionate formulation; intra-articular injection / Pain / osteoarthritisPain due to knee osteoarthritisPhase 2Completed
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- EVO756EVO756 / MRGPRX2 / Oral small-molecule antagonist / Chronic inflammatory diseasesChronic Spontaneous UrticariaPhase 2Atopic DermatitisPhase 2MigrainePhase 1
- EVO301EVO301 / IL-18 / Long-acting injectable SAFA-IL-18BP fusion protein / Chronic inflammatory diseasesAtopic DermatitisPhase 2Ulcerative ColitisPhase 1
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- DURAVYUEYP-1901 / DURAVYU / VEGF receptors; JAK1; PDGFR / vorolanib intravitreal insert; tyrosine kinase inhibitor in Durasert E bioerodible sustained-release insert / Retinal diseasesWet age-related macular degenerationPhase 3Trial underway; LUGANO and LUCIA fully enrolled; LUGANO topline data expected mid-2026, LUCIA to closely followGlobalDiabetic macular edemaPhase 3COMO and CAPRI pivotal trials underway; enrollment completion expected 3Q 2026Global
- Undisclosed candidatesDurasert E programs / Retinal diseasesRetinal diseasesPre-clinicalIn progress
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- FID-007FID-007 / Cytotoxic / Nanoencapsulated paclitaxel / OncologyHead and Neck (H&N) cancer, 2nd linePhase 2Ongoing; interim findings expected June 2026Ampullary or ICI resistant cancerGo/no-go based on H&N study
- FID-022FID-022 / Cytotoxic / OncologyColon cancerPhase 1Ongoing; dosing for 3rd dose level ongoingPancreatic cancerPhase 1Ongoing; dosing for 3rd dose level ongoingOvarian cancerPhase 1Ongoing; dosing for 3rd dose level ongoing
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- RevitaDuodenal mucosa / Endoscopic hydrothermal ablation / ObesityWeight maintenance post-GLP-1 in obesityPivotalREMAIN-1 randomization completed; 6-mo topline expected early Q4 2026US
- RejuvaRJVA-001 / Pancreatic beta cells / AAV9 gene therapy / Type 2 DiabetesType 2 diabetesPhase 1/2CTA submitted; FIH dosing & preliminary data expected H2 2026 pending approvalEUAustralia
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- BatoclimabIMVT-1401
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- FG-3246FOR46 / CD46 / Antibody-Drug Conjugate (ADC) / OncologyMetastatic Castration-Resistant Prostate Cancer (mCRPC)Phase 2OngoingUnited States
- roxadustatFG-4592 / HIF-PH / Small Molecule / Rare DiseaseAnemia associated with lower-risk myelodysplastic syndromes (LR-MDS)Phase 3PlannedUnited States
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- rondecabtagene autoleucelLYL314 / Ronde-cel / CD19 / CD20 / CAR T-cell therapy / OncologyRelapsed/Refractory Large B-cell Lymphoma (LBCL) - 2LPhase 3ActiveUSRelapsed/Refractory Large B-cell Lymphoma (LBCL) - 3L+PivotalActiveUS
- LYL273LYL273 / GCC (Guanylyl Cyclase-C) / CD19 / CAR T-cell therapy / OncologyRefractory Metastatic Colorectal Cancer (mCRC)Phase 1ActiveUS
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- MT-601neldaleucel / Survivin, PRAME, NY-ESO-1, MAGE-A4, SSX2, WT-1 / T Cell Therapy (MAR-T cell) / OncologyLymphomaPancreatic Cancer
- MT-401-OTSzelenoleucel / Multi-Tumor Associated Antigens / Allogeneic T Cell Therapy / OncologyAcute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)
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- ObicetrapibAMG-899 / CETP / Small Molecule / CardiometabolicPrimary hypercholesterolemia (HeFH and non-familial or mixed dyslipidemia)RegistrationOngoingGlobalEuropeAtherosclerotic Cardiovascular Disease (ASCVD)Phase 3OngoingGlobal
- Obicetrapib / Ezetimibe FDCCETP / NPC1L1 / Small Molecule / CardiometabolicPrimary hypercholesterolemia (HeFH and non-familial or mixed dyslipidemia)RegistrationOngoingGlobalEurope
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- NRX-101NMDA and 5-HT2A receptors / Small molecule / Central Nervous SystemBipolar Depression with Acute Suicidal Ideation and Behavior (ASIB)Phase 3ActiveUnited StatesBipolar Depression with Subacute Suicidal Ideation and Behavior (SSIB)Phase 2/Phase 3ActiveUnited StatesDepression and Suicidality (in association with Transcranial Magnetic Stimulation)Phase 3ActiveUnited States
- NRX-100KETAFREE / NMDA receptor / Small molecule / Central Nervous SystemAcute Suicidal Depression / Suicidal Ideation in DepressionRegistrationActiveUnited States
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- RinzimetostatORIC-944 / PRC2 (EED subunit) / Small molecule / OncologyMetastatic Castration-Resistant Prostate Cancer (mCRPC)Phase 1bActiveGlobal
- EnozertinibORIC-114 / EGFR / HER2 (exon 20 and PACC/atypical mutations) / Small molecule / OncologyNon-Small Cell Lung Cancer (NSCLC)Phase 1bActiveUnited StatesAustraliaCanadaHong KongMalaysiaPolandSouth KoreaSpainTaiwanUnited Kingdom
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- rhenium Re186 obisbemeda186RNL / REYOBIQ / Radiotherapeutic / OncologyRecurrent GlioblastomaLeptomeningeal MetastasesPediatric Brain Cancer
- Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere188RNL-BAM / Radiotherapeutic / OncologyHepatocellular CarcinomaMetastatic Colorectal Cancer
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- Micvotabart pelidotinMICVO, PYX-201 / EDB+FN / Antibody-Drug Conjugate (ADC) / OncologySolid TumorsRecurrent and Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
- PYX-106PYX-106 / Siglec-15 / Monoclonal Antibody (mAb) / OncologySolid Tumors
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- BempikibartADX-914
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- vusolimogene oderparepvecRP1 / HSV-1 oncolytic virus encoding GALV-GP R-protein and GM-CSF / Oncolytic Virus / OncologyAdvanced MelanomaPhase 3Complete Response LetterUSNon-melanoma Skin Cancers (CSCC, MCC, BCC, Angiosarcoma)Phase 2ActiveUS
- RP2RP2 / Oncolytic virus / Oncolytic Virus / OncologyMetastatic Uveal MelanomaPhase 2ActiveUSHepatocellular CarcinomaPhase 2ActiveUS
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- BIM-IOL SystemBimatoprost Drug Pad-IOL System
- BIM-DRSBimatoprost Drug Ring System
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- SLS009tambiciclib
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- RevumenibSNDX-5613 / Revuforj / Menin / Small Molecule / OncologyR/R acute leukemia with KMT2A translocation (AUGMENT-101-2A)ApprovedApprovedUSR/R NPM1m AML (AUGMENT-101-2C)ApprovedApprovedUSFrontline unfit NPM1m and KMT2Ar acute leukemias (EVOLVE-2)Phase 3ActiveUS
- AxatilimabSNDX-6352 / Niktimvo / CSF-1R / Monoclonal Antibody / Oncology / ImmunologyRefractory Chronic GVHD (AGAVE-201)ApprovedApprovedUSFrontline Chronic GVHD (corticosteroids combination)Phase 3ActiveUSFrontline Chronic GVHD (ruxolitinib combination)Phase 2ActiveUS
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- Tralesinidase AlfaTA-ERT / Alpha-N-acetylglucosaminidase (NAGLU) / Enzyme Replacement Therapy / Neurology / Rare DiseaseMucopolysaccharidosis Type IIIB (MPS IIIB) / Sanfilippo Syndrome Type BPhase 3ActiveGlobal
- TildacerfontCorticotropin-releasing factor type-1 (CRF1) receptor / Small Molecule / Neurology / PsychiatryMajor Depressive Disorder (MDD)Phase 2ActiveEurope
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- SL-325SL-325 / DR3 (Death Receptor 3) / Monoclonal Antibody / Inflammatory and Immune-Mediated DiseasesInflammatory Bowel Disease (IBD)Crohn's DiseaseUlcerative Colitis
- SL-425SL-425 / DR3 (Death Receptor 3) / Monoclonal Antibody / Inflammatory and Immune-Mediated DiseasesInflammatory Bowel Disease (IBD)
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- TARA-002TARA-002 / Broad immunopotentiator / Cell therapy / Oncology / Rare DiseasesNon-Muscle Invasive Bladder Cancer (NMIBC)Phase 2ActiveUnited StatesLymphatic Malformations (LMs)Phase 2ActiveUnited States
- IV Choline ChloridePhospholipid substrate replacement / Small molecule / Intravenous replacement therapy / Rare DiseasesPatients dependent on long-term parenteral support (PS) / Choline deficiencyPhase 3ActiveUnited States