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NEWS

Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

Shots: The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
13 hours ago

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NEWS

Novatim Immune Therapeutics (Keyi Pharmaceutical) Inks a ~$1.16B Licensing Deal with RADIANCE Biopharma for KY-0301 to Treat Cancer

Shots: Novatim has entered into an exclusive global licensing agreement (excl. China) with RADIANCE Biopharma for KY-0301 to treat cancer  As per the deal, RADIANCE Biopharma will receive rights to develop, register, & commercialize KY-0301 globally (excl. China) in exchange for $15M upfront, ~$150M in R&D & registration milestones & ~$1B in commercial milestone, with progressive…
September 3, 2025

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NEWS

SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC

Shots: The US FDA has granted BTD to izalontamab brengitecan (iza-bren) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations progressing on or after EGFR TKI & Pt-based CT Designation was backed by data from 3 ongoing trials: BL-B01D1-101 & BL-B01D1-203 in China led by Sichuan Biokin, & the global BL-B01D1-LUNG-101…
August 18, 2025

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NEWS

Mabwell Reports First Patient Dosing in P-I Trial of Bulumtatug Fuvedotin for Triple-Negative Breast Cancer (TNBC) in the US

Shots: Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP Bulumtatug Fuvedotin, a Nectin-4–targeting…
August 13, 2025

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NEWS

Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Shots:                                                                                                                                                                  China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC) sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UC Toripalimab is an anti-PD-1…
August 12, 2025

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Astellas & Evopoint Bio
NEWS

Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011

Shots: Evopoint Biosciences has granted Astellas exclusive license to develop & commercialize XNW27011 globally, excl. Mainland China, Hong Kong, Macao & Taiwan As per the deal, Evopoint will receive $130M upfront as well as ~$70M as near-term payments in addition to ~$1.34B in development, regulatory & commercial milestones, with net sales-based royalties XNW27011, an CLDN18.2-specific…
May 30, 2025

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Genmab & Pfizer
NEWS

Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Shots: The EC has approved Tivdak an ADC, as a monotx. for adults (n=502) with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy Approval was backed by P-III (innovaTV 301) global trial evaluating Tivdak vs CT alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) The trial met its 1EP of OS,…
April 1, 2025

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Viewpoints_Dr. Lara S. Sullivan and Dr. Ronald Herbst
VIEWPOINTS

PharmaShots Interview: Pyxis Oncology’s Dr. Lara S. Sullivan and Dr. Ronald Herbst Share Insights on the Importance of Series B Funding to Advance their Portfolio

In an interview with PharmaShots, Dr. Lara S. Sullivan, Chief Executive Officer, and Dr. Ronald Herbst, Chief Scientific Officer of Pyxis Oncology share insight on the importance of Series B funding and shed light on the company's strategy and near-term goals. Shots: Pyxis Oncology reported that it raised $152M in a series B on the heels of…
April 26, 2021

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