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The Month Ahead – 3Q Catalysts
研报英文原文证据摘录
The Month Ahead – 3Q Catalysts
IdeaMbinary a non-event to estimates on the upside with residual risk limited to a narrow
label or CRL.
• Scenario analysis: approval (base case, highly likely given HERIZON-GEA-01) a
modest +5-10% move vs -20%+ (~$200/sh) in the low-probability rejection case
based on the compelling clinical evidence and outcomes observed in HERIZON-
GEA.
KYMR
Ph1 HV data for KT-579 in 2H26
Catalyst Importance: Neutral. Catalyst Surprise: In-line.
• KYMR will be reporting data from its Ph1 SAD/MAD study of KT-579 (oral IRF5
degrader) in HVs in 2H26.
• In addition to safety, the study will evaluate target engagement (IRF5 degradation
in blood) and PD (whole blood ex vivo stimulation assays evaluating
proinflammatory cytokines, type I IFNs, and inflammatory pathway gene
transcripts by TLR 7/8/9 agonists).
• A key objective will be showing robust IRF5 degradation (at least 90%) and a
reduction in PD biomarkers; based on preclinical data, management believes a ~50-
80% reduction in inflammatory biomarkers should translate to clinical activity.
• Assuming positive data, KYMR indicated plans to subsequently initiate a study in
lupus patients.
• Given the early nature of the data and value tied to KT-621 in KYMR shares, we
anticipate shares trading +/- ~5-10% with the KT-579 update.
MRNA
Interim Ph3 data for intismeran autogene (INT) in adjuvant melanoma
Catalyst Importance: High. Catalyst Surprise: In-line.
• MRNA/MRK are developing intismeran autogene (Individualized Neoantigen
Therapy/INT) across a range of tumor types, with first interim Ph3 data (adjuvant
melanoma) expected in 2Q/3Q26 per our estimate
• 5-yr Ph2 data show that intismeran + Keytruda (PD1) reduced the risk of
recurrence or death in adjuvant melanoma by 49% as compared to Keytruda alone.
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