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| Clinical Trial | Certified Prospective Prediction | Prediction Validation | Prediction Result | |
|---|---|---|---|---|
Phase 3 | Prediction Index1756 NCTIDNCT04411641 Drug NameTolebrutinib Drug MoACNS-penetrant BTK inhibitor Drug Modalitysmall molecule Drug ClassFirst-In-Class Therapeutic AreaNervous System Diseases IndicationNonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Human Patients1131 SponsorSanofi TickerSNY | Prediction Date 19 Aug 2024 Technical PredictionFAILURE (statistically insignificant clinical benefit in 6-month CDP against placebo) Commercial PredictionFAILURE (commercially insufficient clinical benefit in 6-month CDP inferior to siponimod) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter Ahead Q4'24 Batch 12 | Readout Date 24 Dec 2025 Prediction To Readout492 days in advance Readout Data Interpretationtolebrutinib achieved 31% placebo-adjusted reduction in 6-month (CDP); non-superior to siponimod’s 29-33% placebo-adjusted reduction in 6-month CDP in the EXPAND trial NCT01665144 (see add'l link below); FDA issued CRL rejecting Sanofi's NDA for tolebrutinib for NR-SPMS Press ReleasePress Release Additional Readout DataAdd'l Clinical Benefit Comparison Data | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically significant and commercially insufficient Prediction ClassificationTrue Negative (TN) |
Phase 2 Phase 3 | Prediction Index1109 NCTIDNCT05031780 Drug NameMitapivat (AG-348) Drug MoApyruvate kinase activator Drug Modalitysmall molecule Drug ClassFirst-In-Class Therapeutic AreaHemic and Lymphatic Diseases IndicationSickle Cell Disease Human Patients286 SponsorAgios Pharmaceuticals TickerAGIO | Prediction Date 28 Jul 2025 Technical Predictionpartial SUCCESS (statistically maybe significant yet moderate clinical benefit in Hb response rate and SCPCs compared with placebo yet featuring a negative dose-response relationship and moderate toxicity) Commercial PredictionFAILURE (commercially insufficient clinical benefit in Hb response rate/SCPCs/SAEs slightly inferior to the SoC hydroxyurea) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ4'25 Batch 4 | Readout Date 19 Nov 2025 Prediction To Readout114 days in advance Readout Data Interpretationmitapivat failed to meet the key primary efficacy endpoint of annualized rate of SCPCs (pain crises) or the key secondary efficacy endpoint PROMIS Fatigue Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically insignificant and commercially insufficient Prediction ClassificationTrue Negative (TN) |
Phase 2 | Prediction Index1957 NCTIDNCT04945460 Drug NameSotatercept Drug MoAActRIIA/ACVR2A ligand trap Drug Modalityfusion protein biologic Drug ClassFirst-In-Class Therapeutic AreaCardiovascular Diseases Indicationcombined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF) Human Patients164 SponsorMerck & Co. TickerMRK | Prediction Date 1 Apr 2025 Technical Predictionpartial FAILURE (statistically maybe significant yet very weak additive clinical benefit in PVR/6MWD/LVEF compared with placebo as an adjunctive therapy) Commercial PredictionFAILURE (commercially insufficient additive clinical benefit in PVR/6MWD/LVEF inferior to semaglutide as an adjunctive therapy) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ2'25 Batch 14a | Readout Date 18 Nov 2025 Prediction To Readout231 days in advance Readout Data Interpretationsotatercept achieved statistical significance in PVR compared with placebo at week 24 (no detailed data and no p-value); yet sotatercept probably didn’t achieve statistical significance in 6MWD (not mentioned; no detailed data and no p-value) Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically partially significant (weak efficacy in PVR but not 6MWD) and commercially probably insufficient Prediction ClassificationTrue Negative (TN) |
Phase 3 | Prediction Index590 NCTIDNCT05152147 Drug NameZanidatamab Drug MoAbiparatopic anti-HER2 inhibitor Drug Modalitymonoclonal antibody (mAb) Drug ClassFirst-In-Class Therapeutic AreaNeoplasms Indication1L HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers Human Patients920 SponsorJazz Pharmaceuticals TickerJAZZ | Prediction Date 19 Jan 2025 Technical PredictionSUCCESS (statistically significant clinical benefit in ORR/PFS for [zanidatamab + tislelizumab + chemotherapy] at least numerically superior to [zanidatamab + chemotherapy]; both superior to [trastuzumab + chemotherapy]) Commercial PredictionSUCCESS (commercially sufficient clinical benefit in OS for [zanidatamab + tislelizumab + chemotherapy] at least numerically superior to [zanidatamab + chemotherapy]; both superior to [trastuzumab + chemotherapy]) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ2'25 Batch 3 | Readout Date 17 Nov 2025 Prediction To Readout302 days in advance Readout Data Interpretationzanidatamab + tislelizumab + chemotherapy achieved superiority in both PFS and OS compared with the control arm trastuzumab plus chemotherapy; whereas zanidatamab + chemotherapy achieved superiority in PFS only (not in OS) compared with the control arm trastuzumab plus chemotherapy Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically significant (superior PFS for both doublet and triplet combo therapies) and commercially sufficient (superior OS for triplet combo therapy) Prediction ClassificationTrue Positive (TP) |
Phase 2 | Prediction Index1909 NCTIDNCT06555783 Drug NameAlixorexton (ALKS2680) Drug MoAOX2R agonist Drug Modalitysmall molecule Drug ClassFirst-In-Class Therapeutic AreaNervous System Diseases IndicationNarcolepsy Type 2 Human Patients80 SponsorAlkermes TickerALKS | Prediction Date 8 Feb 2025 Technical PredictionSUCCESS (statistically significant clinical benefit in MWT for NT2 compared with placebo featuring a mild positive dose-response relationship and a moderate positive dose-toxicity relationship) Commercial PredictionSUCCESS (commercially sufficient clinical benefit in MWT for NT2; non-inferior non-superior to ALKS2680/TAK861 in the best-case scenarios of optimal dosing regimens) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ2'25 Batch 9 | Readout Date 12 Nov 2025 Prediction To Readout277 days in advance Readout Data InterpretationAlixorexton 14mg/18mg met the primary endpoint in MSL on MWT at week 8 (p<0.05) and Alixorexton 18mg met the key secondary endpoint in ESS (p<0.05) Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically significant (featuring a mild positive dose-response relationship) and commercially sufficient (no approved treatment so far) Prediction ClassificationTrue Positive (TP) |
Phase 1 Phase 2 | Prediction Index2023 NCTIDNCT06677307 Drug NameKRRO-110 Drug MoALNP-encapsulated ADAR-dependent mRNA single-base modifier Drug Modalityoligonucleotide Drug ClassFirst-In-Class Therapeutic AreaCardiovascular Diseases and Nutritional and Metabolic Diseases IndicationAlpha-1 Antitrypsin Deficiency (AATD) Human Patients64 SponsorKorro Bio TickerKRRO | Prediction Date 14 May 2025 Technical PredictionSUCCESS (statistically significant clinical benefit in lung AAT/NE concentration compared with placebo) Commercial PredictionFAILURE (commercially insufficient clinical benefit in FEV1 moderately inferior to WVE006) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ3'25 Batch 8 | Readout Date 12 Nov 2025 Prediction To Readout182 days in advance Readout Data InterpretationKRRO110 produced functional protein that hasn’t reached the projected level; so further development has been discontinued for low efficacy Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically probably significant and commercially insufficient Prediction ClassificationTrue Negative (TN) |
Phase 3 | Prediction Index2048 NCTIDNCT04544449 Drug NameFenebrutinib Drug MoACNS-penetrant BTK inhibitor Drug Modalitysmall molecule Drug ClassFirst-In-Class Therapeutic AreaNervous System Diseases IndicationPrimary Progressive Multiple Sclerosis Human Patients985 SponsorRoche Group TickerRHHBY | Prediction Date 28 Jul 2025 Technical PredictionSUCCESS (statistically significant yet moderate clinical benefit in 12-week CDP compared with placebo) Commercial PredictionSUCCESS (commercially sufficient yet moderate clinical benefit in 12-week CDP moderately superior to ocrelizumab) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ4'25 Batch 4 | Readout Date 10 Nov 2025 Prediction To Readout105 days in advance Readout Data Interpretationfenebrutinib met the primary endpoint of delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment; being numerically superior to ocrelizumab Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically significant and commercially sufficient (ocrelizumab is the only SoC) Prediction ClassificationTrue Positive (TP) |
Phase 2 | Prediction Index1389 NCTIDNCT06127043 Drug NameRosnilimab Drug MoAanti-PD1 agonist Drug Modalitymonoclonal antibody (mAb) Drug ClassFirst-In-Class Therapeutic AreaImmune System Diseases IndicationModerate to Severe Ulcerative Colitis Human Patients132 SponsorAnaptysBio TickerANAB | Prediction Date 28 Jul 2025 Technical PredictionFAILURE (statistically insignificant clinical benefit in modified Mayo score or clinical remission compared with placebo) Commercial PredictionFAILURE (commercially insufficient clinical benefit in modified Mayo score or clinical remission moderately inferior to tulisokibart) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ4'25 Batch 5 | Readout Date 10 Nov 2025 Prediction To Readout105 days in advance Readout Data Interpretationrosnilimab failed to meet the primary efficacy endpoint of modified Mayo Score (mMS) compared with placebo Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically insignificant and commercially insufficient Prediction ClassificationTrue Negative (TN) |
Phase 3 | Prediction Index782 NCTIDNCT05208047 Drug NameBezuclastinib Drug MoATKI inhibitor Drug Modalitysmall molecule Drug ClassFirst-In-Class Therapeutic AreaNeoplasms IndicationGastrointestinal Stromal Tumors (GIST Human Patients442 SponsorCogent Biosciences TickerCOGT | Prediction Date 13 Oct 2023 Technical PredictionSUCCESS (statistically significant additive clinical benefit) Commercial PredictionSUCCESS (commercially sufficient additive clinical benefit) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter Ahead2H’23 Batch 24 | Readout Date 10 Nov 2025 Prediction To Readout759 days in advance Readout Data Interpretationbezuclastinib + sunitinib achieved 16.5 months mPFS vs 9.2 months mPFS achieved by sunitinib mono therapy (HR= 0.50 p<0.0001); bezuclastinib+sunitinib achieved 46% ORR vs 26% ORR achieved by sunitinib mono therapy (p<0.0001); wait for OS data Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically significant (ORR/PFS) and commercially TBD Prediction ClassificationTrue Positive (TP) |
Phase 2 | Prediction Index1662 NCTIDNCT06267846 Drug NameNBI-1070770 Drug MoAoral anti-NMDAR-NR2B NAM Drug Modalitysmall molecule Drug ClassBest-In-Class Therapeutic AreaMental Disorders IndicationMajor Depressive Disorder Human Patients73 SponsorNeurocrine Biosciences TickerNBIX | Prediction Date 6 Jul 2024 Technical PredictionFAILURE (statistically maybe significant yet very weak additive clinical benefit in MADRS) Commercial PredictionFAILURE (commercially insufficient additive clinical benefit in MADRS inferior to lumateperone) Timestamped PDFTimestamped PDF Delivered to Clients
Quarter AheadQ3'25 Batch 10 | Readout Date 10 Nov 2025 Prediction To Readout492 days in advance Readout Data InterpretationNBI-1070770 failed to meet the primary efficacy endpoint of MADRS compared with placebo Press ReleasePress Release | Prediction AccuracyCorrect Prediction Clinical Benefit Conclusionstatistically insignificant and commercially insufficient Prediction ClassificationTrue Negative (TN) |