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Source document· November 24, 2025

Lilly to present data from two positive Phase 3 studies of Jaypirca (pirtobrutinib) in chronic lymphocytic leukemia at the 2025 American Society of Hematology (ASH) Annual Meeting

View original at finance.yahoo.com
Lilly to present data from two positive Phase 3 studies of Jaypirca (pirtobrutinib) in chronic lymphocytic leukemia at the 2025 American Society of Hematology (ASH) Annual Meeting Results from the BRUIN CLL-314 study comparing Jaypirca (pirtobrutinib) to Imbruvica (ibrutinib) – the first-ever head-to-head Phase 3 study…
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  • Jaypirca is the first and only approved non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor

    80% confidence
  • Data from across the pirtobrutinib development program and investigator-led studies reinforce the medicine's unique clinical profile and its potential role across treatment settings and B-cell malignancies

    80% confidence
  • Continued approval for Jaypirca's MCL and CLL/SLL indications may be contingent upon verification and description of clinical benefit in a confirmatory trial

    80% confidence
  • BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients

    80% confidence
  • Lilly has been pioneering life-changing discoveries for nearly 150 years

    80% confidence
  • Pirtobrutinib is 300 times more selective for BTK versus 98% of other kinases tested in preclinical studies

    80% confidence
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Q4 2026 Biopharma Catalyst Cluster: Late-Stage Readouts and Regulatory Milestones
October 2026 brings a dense run of Phase 3 wins (ALOFT-IPF, RESTORE-3), new data presentations (Roche, Bayer, Lilly, Vertex, Galderma) and regulatory steps (FDA acceptance of Roche's vamikibart BLA, Scholar Rock's EMA resubmission). The next big catalyst is the ivonescimab FDA PDUFA date on 2026-11-14. Obesity combination studies (REDEFINE 4, TOGETHER-PsO) and the 2027 Maritime-1 completion point to more catalysts ahead. QAIAx's speculative AI-linked trial claims (the QIII pilot, targeted for 2027) are an unrelated micro-cap sideshow with weak evidence, and have little in common with the large-cap pipeline news.
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EPKINLY Regulatory-Clinical Success Cascade
High probability of expanded label indications, additional combination approvals, and competitive positioning strength in follicular lymphoma market. Predicts positive commercial uptake and potential accelerated review for related indications.
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ING Group
Both facts record the same metric (shares_outstanding) for ING Group at the identical observation date (2025-12-31). FACT A states 2,902,437,688 shares; FACT B states 2,902 million shares (2,902,000,000). The difference is 437,688 shares (~0.015%). This is a genuine value conflict, though the discrepancy appears to result from FACT B rounding to the nearest million while FACT A provides the precise count.
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