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Calls ahead of readouts · BioPharma Dive’s 2H 2026 watch list ·

All Ten Most-Anticipated Readouts of 2H 2026. Called Before the Data.

On , BVCT shared fourteen sealed calls on the ten entries BioPharma Dive listed for 2H 2026: seven GO, seven NO-GO. CARDIO-TTRansform (No. 1863, sealed ) read out , classified True Negative (TN). INTerpath-001 (No. 2161) and HARBOR (No. 2157) have since been classified True Positive (TP) and True Negative (TN); eleven await scoring.

Fourteen sealed, timestamped, patient-data-independent predictions against BioPharma Dive’s “10 clinical trials to watch in the second half of 2026”

On , BioPharma Dive published the ten clinical readouts the industry is watching most closely in the second half of this year. Between them, these programmes represent, in our estimate, tens of billions of dollars in committed clinical capital and expected peak sales — across adjuvant melanoma, Alzheimer’s psychosis, ATTR cardiomyopathy, chronic urticaria, IBD, lupus, myotonic dystrophy, NSCLC, pneumococcal vaccination and stroke prevention.

BVCT has now issued a sealed, timestamped ex-ante clinical benefit prediction on every one of them — fourteen predictions in total, covering all ten entries (all fourteen are listed below; the ones scored so far link to their dashboard records). Each prediction was generated with no patient data ingested and no machine-learning training on past trial outcomes: each simulation of the drug-body causal interaction within BVCT virtual human patients identifies the underlying mechanisms of the human body that determine the clinical benefits of a novel medicine.

Every prediction below is timestamped with a PandaDoc certificate carrying an immutable signature timestamp. They were shared on , before their readouts, except No. 1863, which had read out on . Each call will be checked against its readout; those scored so far link to their dashboard records below.

One entry on the list — AstraZeneca and Ionis’ CARDIO-TTRansform — announced its topline readout on , which has been perfectly aligned with BVCT’s prediction sealed 574 days earlier (see below).

Six NO-GO calls. Seven GO calls. One already confirmed. Timestamped in advance. Delivered before readouts.

The GO Calls.

Seven programmes where BVCT projects sufficient clinical benefit — quantified against the named comparator standard of care, not against placebo alone.

Sealed GO — Pending 2H 2026 Readout

No. 1668Pending readout

Summit / Akeso · Ivonescimab (PD-1 / VEGF) · HARMONi-3

NCT05899608

Sealed GO — Pending 2H 2026 Readout

Commercial: SUCCESS — commercially sufficient benefit in OS weakly superior to pembrolizumab + chemotherapy with HR < 0.8.

Technical: SUCCESS — statistically significant benefit in ORR / PFS, weakly superior to pembrolizumab + chemotherapy with HR < 0.8.

Ref: ZFK2S-WCCLN-4NLFG-N5EEG

Phase 3 · 1L Metastatic NSCLC.

No. 2147Pending readout

Celldex · Barzolvolimab (anti-KIT) · EMBARQ-CSU1

NCT06445023

Sealed GO — Pending 2H 2026 Readout

Commercial: SUCCESS — commercially sufficient benefit in ISS7 / UAS7 for both omalizumab-naïve and omalizumab-refractory patients.

Technical: SUCCESS — statistically significant clinical benefit in ISS7 / UAS7 vs. placebo.

Ref: TWW4L-IFMU6-S5FVA-REQVA

Phase 3 · Chronic Spontaneous Urticaria.

No. 2153Pending readout

Janssen / BMS · Milvexian (Factor XIa) · LIBREXIA-AF

NCT05757869

Sealed GO — Pending 2H 2026 Readout

Commercial: SUCCESS — commercially sufficient in stroke / non-CNS systemic embolism prevention and in ISTH major bleeding prevention both slightly-to-moderately superior to apixaban with 0.6 < HR < 0.8.

Technical: SUCCESS — statistically significant benefit in stroke / non-CNS systemic embolism prevention and in ISTH major bleeding prevention vs. placebo.

Ref: OG8SS-ZSZYG-QX9DS-HTOM3

Phase 3 · Atrial Fibrillation · vs. Apixaban.

No. 2158Pending readout

Vaxcyte · VAX-31 (31-valent PCV) · OPUS-1

NCT07284654

Sealed GO — Pending 2H 2026 Readout

Commercial: SUCCESS — commercially sufficient benefit in OPT GMT for age between 18 and 49 years at least numerically superior for the age cohort greater than 50 years with RR < 0.9). SUCCESS —commercially sufficient clinical benefit in severe pneumonia prevention weakly superior to PCV20 / PCV21 with HR < 0.8 for both age greater than 50 years and age between 18 and 49 years due to pAMF.

Technical: SUCCESS — statistically significant benefit in OPT GMT at most numerically inferior to PCV20 / PCV21 for shared serotypes (1.0 < RR < 1.2) and superior for novel serotypes with RR < 0.8.

Ref: HANPL-V8SAM-PYCPA-TXRDM

Phase 3 · Pneumococcal Vaccine · vs. PCV20 / PCV21.

No. 2161Pending readout

Merck / Moderna · Intismeran autogene (V940) + pembrolizumab · INTerpath-001

NCT05933577

Sealed GO — Pending 2H 2026 Readout

Commercial: SUCCESS — commercially sufficient additive benefit in RFS weakly-to-moderately superior to pembrolizumab with RR < 0.7 and in OS weakly-to-moderately superior to pembrolizumab with HR < 0.7.

Technical: SUCCESS — statistically significant additive clinical benefit in RFS and OS vs. placebo.

Ref: UF97Q-NMVZE-JUBGE-DF3AK

Phase 3 · Adjuvant High-Risk Melanoma. Read out since : see the record below.

Since scored on the dashboard: True Positive (TP), readout →

No. 2162Pending readout

Bristol Myers Squibb · KarXT (Cobenfy) · ADEPT-2

NCT06126224

Sealed GO — Pending 2H 2026 Readout

Commercial: SUCCESS — commercially sufficient yet moderate benefit in NPI-C: H+D score as the first approvable treatment in this indication yet slightly inferior to ITI-1284 with RR > 1.2.

Technical: SUCCESS — statistically significant clinical benefit in NPI-C: H+D score vs. placebo.

Ref: WX2FT-EQEPH-ZEWK8-HUTMJ

Phase 3 · Psychosis Associated with Alzheimer’s Disease.

No. 2163Pending readout

Celldex · Barzolvolimab (anti-KIT) · EMBARQ-CSU2

NCT06455202

Sealed GO — Pending 2H 2026 Readout

Commercial: SUCCESS — commercially sufficient benefit in ISS7 / UAS7 weakly-to-moderately superior to remibrutinib with RR < 0.7 and moderately-to-strongly superior to dupilumab with RR < 0.5.

Technical: SUCCESS — statistically significant clinical benefit in ISS7 / UAS7 vs. placebo.

Ref: QHLM6-7ZNHA-FJ7UA-CNW8P

Phase 3 · Chronic Spontaneous Urticaria.

The NO-GO Calls.

Seven programmes on the watch list where BVCT’s virtual patients project insufficient clinical benefit to clear the registrational or the commercial bar — one already confirmed by readout, six still pending (when these calls were shared).

Sealed NO-GO — Validated 2H 2026 Readout

No. 1863Correct Prediction

CARDIO-TTRansform · Eplontersen

Sponsor
AstraZeneca / Ionis Pharmaceuticals
Phase
Phase 3
Prediction Date
Readout Date
Prediction To Readout
574 days in advance
Prediction Classification
True Negative (TN)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in CV mortality/CV recurrence compared with SoC alone (tafamidis))
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet weak additive clinical benefit in 6MWT/KCCQ/all-cause mortality at most weakly superior to SoC alone (tafamidis))

AstraZeneca & Ionis · Eplontersen (GalNAc-ASO TTR silencer) · CARDIO-TTRansform · Phase 3 · Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). Sealed . Confirmed : primary composite endpoint missed; no effect of eplontersen observed in patients on stabilizer therapy at baseline. The dashboard classifies the readout as True Negative (TN). Lead time 574 days; AstraZeneca lost approximately £19 billion of market value on , according to market reports (IG UK). Ref: N6JH2-UHPRP-IZ7RN-I7KF2. Readout source: AstraZeneca and Ionis announcement (also on astrazeneca.com). See No. 1863 on the dashboard. The full case: eplontersen case study.

Sealed NO-GO — Pending 2H 2026 Readout

No. 1563Pending readout

Biogen · Litifilimab (BIIB059) · TOPAZ-1

NCT04895241

Sealed NO-GO — Pending 2H 2026 Readout

Commercial: FAILURE — commercially insufficient additive benefit to SoC in SRI-4 / CLASI-50 / BICLA moderately inferior to enpatoran with RR > 1.4.

Technical: partial FAILURE — statistically maybe significant yet very weak additive benefit to SoC in SRI-4 / CLASI-50 / BICLA vs. placebo, featuring a negative dose-response relationship.

Ref: PRYQ2-SXXER-2U9ML-LNZPT

Phase 3 · Systemic Lupus Erythematosus.

No. 1564Pending readout

Biogen · Litifilimab (BIIB059) · TOPAZ-2

NCT04961567

Sealed NO-GO — Pending 2H 2026 Readout

Commercial: FAILURE — commercially insufficient additive benefit to SoC in SRI-4 / CLASI-50 / BICLA moderately inferior to enpatoran with RR > 1.4.

Technical: partial FAILURE — statistically maybe significant yet very weak additive benefit to SoC in SRI-4 / CLASI-50 / BICLA vs. placebo, featuring a negative dose-response relationship.

Ref: HWQNL-ESRFA-AMBRS-BVHAV

Phase 3 · Systemic Lupus Erythematosus.

No. 2154Pending readout

Janssen / BMS · Milvexian (Factor XIa) · LIBREXIA-STROKE

NCT05702034

Sealed NO-GO — Pending 2H 2026 Readout

Commercial: FAILURE — commercially insufficient benefit in stroke prevention at most numerically superior to SoC with 0.9 < HR < 1.1.

Technical: partial FAILURE — statistically maybe significant yet very weak additive benefit to SoC in stroke prevention vs. placebo.

Ref: CBVKM-GU89X-IZ7GM-M38VE

Phase 3 · Acute Ischemic Stroke & High-Risk TIA.

No. 2157Pending readout

Novartis · Del-desiran (AOC 1001) · HARBOR

NCT06411288

Sealed NO-GO — Pending 2H 2026 Readout

Commercial: FAILURE — commercially insufficient benefit in vHOT and 10MWT slightly inferior to DYNE-101 with RR > 1.2 and moderately inferior to PGN-EDODM1 with RR > 1.4.

Technical: FAILURE — statistically insignificant clinical benefit in vHOT and 10MWT vs. placebo.

Ref: SVNRK-XSFDD-PQ87M-LSBOB

Phase 3 · Myotonic Dystrophy Type 1 (DM1). Read out since : see the record below.

Since scored on the dashboard: True Negative (TN), readout →

No. 2159Pending readout

Takeda · Zasocitinib (TAK-279, TYK2) · Crohn’s disease

NCT06233461

Sealed NO-GO — Pending 2H 2026 Readout

Commercial: FAILURE — commercially insufficient benefit in clinical remission CDAI and endoscopic response SES-CD slightly inferior to deucravacitinib with RR > 1.2 and strongly inferior to tulisokibart with RR > 1.7.

Technical: FAILURE — statistically insignificant benefit in clinical remission CDAI and endoscopic response SES-CD vs. placebo.

Ref: MEFEG-XX7SH-JPDXH-OAOVN

Phase 2 · Moderately-to-Severely Active Crohn’s Disease.

No. 2160Pending readout

Takeda · Zasocitinib (TAK-279, TYK2) · Ulcerative colitis

NCT06254950

Sealed NO-GO — Pending 2H 2026 Readout

Commercial: FAILURE — commercially insufficient benefit in clinical remission mMS numerically-to-slightly inferior to deucravacitinib with RR > 1.1 and moderately-to-strongly inferior to tulisokibart with RR > 1.5.

Technical: FAILURE — statistically insignificant benefit in clinical remission mMS vs. placebo.

Ref: K3STJ-EZQQ7-K9BF7-BHGXB

Phase 2 · Moderately-to-Severely Active Ulcerative Colitis.

Scored on the dashboard since these calls were shared

No. 2161Correct Prediction

INTerpath-001 · intismeran autogene (V940)

Sponsor
Moderna / Merck Co
Phase
Phase 3
Prediction Date
Readout Date
Prediction To Readout
24 days in advance
Prediction Classification
True Positive (TP)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in RFS and OS compared with placebo)
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in RFS weakly-to-moderately superior to pembrolizumab with RR < 0.7 and in OS weakly-to-moderately superior to pembrolizumab with HR < 0.7)

Outcome: Merck and Moderna announced that intismeran autogene plus pembrolizumab met the primary endpoint, RFS, and the secondary endpoint DMFS versus pembrolizumab at a pre-specified interim analysis; OS data are pending. The dashboard classifies the readout as True Positive (TP), 24 days after the call was sealed. Source: Merck and Moderna announcement (also on merck.com). See No. 2161 on the dashboard. The full case: Moderna pipeline case study.

No. 2157Correct Prediction

HARBOR · del-desiran (AOC 1001)

Sponsor
Novartis
Phase
Phase 3
Prediction Date
Readout Date
Prediction To Readout
44 days in advance
Prediction Classification
True Negative (TN)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in vHOT and 10MWT compared with placebo)
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in vHOT and 10MWT slightly inferior to DYNE101 with RR > 1.2 and moderately inferior to PGN-EDODM1 with RR > 1.4)

Outcome: Novartis announced that HARBOR did not meet its primary endpoint, vHOT. The dashboard classifies the readout as True Negative (TN), 44 days after the call was sealed. Source: Novartis announcement. See No. 2157 on the dashboard. The full case: AOC 1001 case study.

Why This Matters to Your Portfolio Committee.

Each BVCT prospective clinical benefit prediction corresponds to a head-to-head phase-3-scale quantification of the clinical effect size of a novel therapy against a named comparator standard of care, backed by a mechanistic causal rationale, sealed and timestamped before the readout.

That distinction is what makes the BVCT prediction actionable before every pipeline decision. A GO call you can defend to a board is one where the root cause is identified, the competitive advantage is quantified, and the timestamp proves it was made before the answer was known. A NO-GO call has the same property — which is why BVCT can save nine-figure sunk cost in R&D and BD&L before it is committed.

BVCT’s prospective record now stands at 674 of 705 ex-ante clinical predictions correct in the cohort frozen on 24 Sep 2026 — 95.6% accuracy, 89.7% PPV (GO calls), 99.1% NPV (NO-GO calls), F1 of 93.8% — against a 28.9% industry baseline (BIO / QLS / Informa 2011–2020, Phase II transition success rate). When these calls were shared, No. 1863 was the most recent confirmation and the thirteen pending calls above were the next test, on the record in advance; No. 2161 and No. 2157 have been scored since (see above).

Every one of these programmes could have carried a per-asset Phase-III effect size call before the clinical capital was committed. So can yours — in seven days, at under 0.1% of the cost of the trial that would answer the question.

Seven days per asset. Before the commit.

Name any asset in your portfolio, the indication, the patient stratum, and the comparator standard of care. Receive a simulated Phase-III effect size, a GO / NO-GO call against your own blockbuster threshold, and a mechanistic causal rationale — within one week. No patient data required. No model training. Sealed and timestamped, so the call can be verified against the readout.

Clinical Foresight Before Decisions. Earlier is Kinder for Patients.

Start at bvct.bioinvestgpt.com →