Summit Therapeutics: BLA diajukan untuk ivonescimab; PDUFA ditetapkan 14 Nov 2026

Kutipan sumber

EX-99.2 3 a20260223q4fy2025earning.htm EX-99.2 a20260223q4fy2025earning Summit Therapeutics Q4 & FY 2025 Earnings Call February 23, 2026 4:30pm ET Forward Looking Statement Any statements in this presentation about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing a

SEC 8-K

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Penting

15 Sep 2026

12.44

SMMTSummit Therapeutics

Summit menyajikan data OS HARMONi yang diperbarui di WCLC 2026

Presentasi konferensiSEC 8-K

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12 Agu 2026

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Summit: Akeso Menerima Persetujuan NMPA untuk Ivonescimab + Kemoterapi pada Kanker Paru Non-Sel Kecil Skuamosa Lini Pertama

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5 Agu 2026

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Summit memulai uji coba Fase II/III HARMONi-GU1 ivonescimab pada kanker kandung kemih lini pertama

Perubahan registri uji klinisSEC 8-K

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23 Jul 2026

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Summit: FDA tetapkan PDUFA 14 Nov 2026 untuk BLA ivonescimab pada EGFRm NSCLC

Tanggal PDUFA ditetapkanSEC 8-KBuka catatan1 pembaruan

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22 Jul 2026

11.10

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Summit: Data OS HARMONi yang Diperbarui Menunjukkan HR 0.76 pada Pasien Barat & Asia

Hasil toplineSEC 8-KBuka catatan10 pembaruan

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30 Apr 2026

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SMMTSummit Therapeutics

Summit: data OS ivonescimab HARMONi-6 di Plenary ASCO 2026

Presentasi konferensiSEC 8-K

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27 Mar 2026

12.15

SMMTSummit Therapeutics

Summit: Data Ivonescimab di ELCC 2026 (HARMONi PFS intrakranial)

Presentasi konferensiSiaran pers perusahaan

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29 Jan 2026

12.35

SMMTSummit Therapeutics

Summit: FDA menerima BLA ivonescimab; PDUFA ditetapkan pada 14 Nov 2026

Permohonan diterimaSEC 8-KBuka catatan

Penting

12 Jan 2026

12.43

SMMTSummit Therapeutics

Summit, GSK akan memulai uji coba ivonescimab + B7-H3 ADC pada pertengahan 2026

Perubahan registri uji klinisSEC 8-K

Material

20 Okt 2025

11.28

SMMTSummit Therapeutics

Summit Therapeutics berencana mengajukan BLA pada Q4 2025 untuk ivonescimab

Permohonan diajukanSEC 8-KBuka catatan