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Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots:The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026)sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…
July 10, 2025

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Regeneron Enters a ~$2B In-Licensing Deal with Hansoh Pharma for HS-20094, Expanding its Obesity Portfolio

Shots:Regeneron has entered into an in-licensing agreement with Hansoh for exclusive global clinical development & commercialization rights of HS-20094, excl. Mainland China, Hong Kong & MacauAs per the deal, Hansoh will receive $80M upfront & ~$1.93B in development, regulatory & sales milestones, with low double digits royalties on sales in Regeneron-licensed areasHS-20094…
June 3, 2025

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Zymeworks
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Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer

Shots:The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTCApproval…
May 30, 2025

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SpringWorks Therapeutics
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The CHMP Adopts Positive Opinion for SpringWorks Therapeutics’ Mirdametinib to Treat NF1-PN

Shots:The CHMP has recommended conditional approval of mirdametinib for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial; EC’s decision expected in Q3’25The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR…
May 26, 2025

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Immutep
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Immutep Reports P-IIb (KEYNOTE-C34/ TACTI-003) Trial Data of Eftilagimod Alfa + Keytruda for Head and Neck Squamous Cell Carcinoma (HNSCC)

Shots:Immutep has reported Cohort B data from P-IIb (KEYNOTE-C34/ TACTI-003) trial, with Cohort B assessing eftilagimod alfa + Keytruda as a 1L treatment of recurrent/metastatic HNSCC pts with PD-L1 expression (CPS <1)As of Mar 31, 2025, trial showed improved mOS of 17.6mos. in evaluable pts (n=31) compared to historical mOS of cetuximab +…
May 6, 2025

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Jazz Pharmaceuticals
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Jazz Pharmaceuticals’ Zanidatamab Secures the CHMP Positive Opinion to Treat HER2+ Biliary Tract Cancer (BTC)

Shots:The CHMP has recommended conditional marketing approval of zanidatamab for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) biliary tract cancer (BTC) adults, who were previously treated with ≥1L of therapy; EC’s potential approval will be valid in 30 EEA statesOpinion was based on P-IIb (HERIZON-BTC-01) trial to assess anti-tumor…
April 28, 2025

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