Sanofi’s 10+ post-readout decisions mirror BVCT’s pre-readout calls sent to Sanofi well in advance
BVCT sealed thirteen calls on Sanofi trials (No. 1972–1984) on and sent them to Sanofi on . Eleven are adjudicable (ten framed NO-GO, one GO), all classified TP or TN on the dashboard, from the psoriasis readout to Sanofi’s discontinuations. No. 1976 is pending; No. 1979 is not adjudicable.
Thirteen BVCT prospective predictions sealed , sent to Sanofi’s board and executives by non-confidential email dated , and adjudicated against public outcomes as of
On , thirteen BVCT patient-data-independent clinical benefit predictions across Sanofi’s development pipeline were sent to Sanofi’s board and executive leadership — including then-CEO Paul Hudson and Head of R&D Houman Ashrafian — all before the readouts.
On , Sanofi’s publicly disclosed post-readout outcomes and decisions are perfectly aligned with the BVCT pre-readout GO/NO-GO calls sent to Sanofi on — eleven adjudicable calls, eleven matching disclosures. On the finer question of head-to-head clinical effect size, ten of the eleven are fully correct and one is partial (No. 1978, note † below; note * flags No. 1980 for completeness).
The full scorecard is on the dashboard: see No. 1972–1975 and 1977–1984 below (No. 1976 is pending and not yet on the dashboard). This is not a retrospective narrative — it is a prospective record, adjudicated against Sanofi’s public disclosures.
100% of the eleven before-readout GO/NO-GO BVCT calls are aligned with Sanofi’s publicly disclosed after-readout outcomes and decisions.
BVCT Ex-Ante NO-GO Calls Confirmed by Sanofi
Ten programmes BVCT called as failing to deliver superior clinical benefit versus standard of care. Every one has since been discontinued, deprioritised, or missed its primary endpoint.
partial FAILURE (statistically maybe significant yet very weak additive clinical benefit in DAS28-CRP/ACR20/ACR50 compared with placebo)
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in DAS28-CRP/ACR20/ACR50)
Rheumatoid arthritis · 264 patients. Outcome: Balinatunfib clinical development programme discontinued after interim Phase 2 analyses in ulcerative colitis and Crohn’s disease did not meet internal efficacy expectations. CORRECT — called 468 days in advance. Source: Sanofi press release, .
partial SUCCESS (statistically significant yet moderate clinical benefit in PASI75 compared with placebo)
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in PASI75/PASI90 moderately inferior to bimekizumab/ixekizumab and slightly inferior to icotrokinra)
FAILURE (statistically insignificant additive clinical benefit to SoC in AECOPD/FEV1/TEAE compared with placebo)
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC in AECOPD/FEV1/TEAE inferior to mepolizumab)
COPD · 1,127 patients. Outcome: AECOPD primary endpoint met (topline, ); FEV1 endpoint not met, reported at ATS 2026; itepekimab programme discontinued. CORRECT* — called 468 days before Sanofi’s discontinuation; the dashboard dates the readout , 42 days after the call. Sources: Sanofi press release (readout), ; Sanofi press release (discontinuation), .
FAILURE (statistically insignificant additive clinical benefit to SoC in AECOPD/FEV1/TEAE compared with placebo)
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC in AECOPD/FEV1/TEAE inferior to mepolizumab)
COPD · 1,239 patients. Outcome: AECOPD primary endpoint not met (topline, ); the FEV1 gain at Week 24, nominal only, was reported at ATS 2026; itepekimab programme discontinued. CORRECT — called 468 days before Sanofi’s discontinuation; the dashboard dates the readout , 42 days after the call. Sources: Sanofi press release (readout), ; Sanofi press release (discontinuation), .
partial FAILURE (statistically insignificant clinical benefit in PEs compared with placebo)
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in PEs)
Non-cystic-fibrosis bronchiectasis · 312 patients. Outcome: Itepekimab development in bronchiectasis deprioritised. CORRECT — called 286 days in advance. Source: Sanofi Q4 and full-year 2025 results, .
partial SUCCESS (statistically maybe significant yet weak clinical benefit in FD-PRO compared with placebo)
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in FD-PRO inferior to pegunigalsidase alfa)
Fabry disease (pain) · 122 patients. Outcome: Venglustat did not meet the primary endpoint. CORRECT — called 290 days in advance. Source: Sanofi press release, .
partial SUCCESS (statistically maybe significant yet weak clinical benefit in eGFR/FD-PRO/left ventricular mass index compared with placebo)
Commercial Prediction
FAILURE (Commercially insufficient clinical benefit in eGFR/FD-PRO/left ventricular mass index inferior to pegunigalsidase alfa, agalsidase alfa or migalastat)
Fabry disease (LV mass) · 104 patients. Outcome: Venglustat did not meet the primary endpoint, failing to demonstrate superior-to-SoC clinical benefit. CORRECT — called 468 days in advance. Source: Sanofi press release, .
SUCCESS (statistically significant clinical benefit in EASI75/EASI90 compared with placebo)
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate clinical benefit in EASI75/EASI90 slightly inferior to upadacitinib and moderately superior to dupilumab)
Atopic dermatitis · 150 patients. Outcome: Did not meet the EASI primary endpoint despite improvements in EASI75; in our cross-trial assessment, inferior to upadacitinib and non-superior to dupilumab. OVERALL CORRECT† — called 354 days in advance. Source: Sanofi press release, .
* No. 1980: the AECOPD endpoint was met while the FEV1 endpoint was not. BVCT had called insufficient additive benefit across both. Scored correct on the programme-level outcome — itepekimab was discontinued — and flagged here for completeness; the dashboard classifies the readout as True Negative (TN).
† No. 1978: correct on the overall GO / NO-GO direction — BVCT called NO-GO and the EASI primary endpoint was missed. On the finer effect-size call the outcome was mixed, with improvements in EASI75, so the entry is recorded as overall correct; see No. 1978 on the dashboard, which classifies the readout as True Negative (TN).
BVCT Ex-Ante GO Calls Confirmed by Sanofi
A track record built only on NO-GO calls proves caution. This is the same sealed batch, same date, opposite direction.
SUCCESS (statistically significant additive clinical benefit to SoC in AAER/FEV1/ACQ5/ACQ7 compared with placebo featuring positive severity-response relationship)
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit to SoC in AAER/FEV1/ACQ5/ACQ7)
Asthma · 685 patients. Outcome: Met primary and key secondary endpoints: significant reduction in exacerbations and improvement in pre-BD FEV1. CORRECT — called 354 days in advance. Source: Sanofi press release, .
Not Yet Adjudicable.
Two of the thirteen cannot be scored today. Both are disclosed rather than dropped.
SUCCESS (statistically significant yet moderate clinical benefit in 6-month CDP compared with placebo)
Commercial Prediction
SUCCESS (commercially sufficient yet moderate clinical benefit in 6month CDP moderately superior to ocrelizumab)
Primary progressive MS · 767 patients. Outcome: Unadjudicable. BVCT’s PPMS disease models, originally correct, were falsely modified based on a post-readout “missed prediction” interpretation of the early partial data readout of the HERCULES trial dated . The false ex-ante modifications were reversed based on the full data readout of the HERCULES trial triggered by the CRL announced on (see No. 1756, HERCULES, on the dashboard for more details). UNADJUDICABLE — excluded from scoring. The dashboard classifies the readout as not adjudicable. PERSEUS did not meet its primary endpoint (; Sanofi press release). Sources: Sanofi press release (topline), ; Sanofi press release (FDA CRL), .
Why This Matters to Your Board.
BVCT — BeatSoC Virtual Clinical Trial — is a prospective, patient-data-independent, pre-readout clinical de-risking platform. It uses proprietary virtual patients to simulate causal, deterministic clinical effect sizes without patient-level data from the trial being predicted, or from any prior trial. Each simulation functions as a head-to-head phase-3-scale quantification of a novel therapy against a named comparator standard of care — regardless of the programme’s actual stage of development.
The Sanofi ex-ante record is the cleanest available demonstration of what that buys a board. Ten NO-GO calls, sealed and sent to the decision-makers, up to 468 days before Sanofi disclosed the same conclusions, with trials run and capital committed. A NO-GO call lets a sponsor decline programmes unlikely to deliver superior benefit and concentrate resources where the benefit is real — which is why, in our view, BVCT can prevent billion-dollar R&D and BD&L budgets from becoming sunk costs before they are committed.
BVCT’s prospective record — 95.6% accuracy, 89.7% PPV (GO calls), 99.1% NPV (NO-GO calls), F1 of 93.8% — now stands at 674 of 705 scored predictions correct in the cohort frozen on 24 Sep 2026, against a 28.9% industry baseline (BIO / QLS / Informa 2011–2020, Phase II transition success rate). The Sanofi batch is one sealed cohort within it.
In our view, Sanofi could have achieved 100% correct GO/NO-GO pipeline decisions in the best interest of stakeholders and patients by adopting BVCT as the end-to-end clinical derisking platform when the calls were sent on .
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.
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