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NEWS

Hansoh Pharma Reports P-III (ARTEMIS-011) Trial Data on Ris-Rez for Osteosarcoma

Shots: Hansoh has reported P-III (ARTEMIS-011) trial data assessing risvutatug rezetecan (HS-20093), a B7-H3–directed ADC, vs CT in pts with osteosarcoma who had progressed or relapsed after receiving ≥2 prior lines of systemic therapy Trial met its 1EP of improved PFS as assessed by the IRC, with consistent benefits observed across 2EPs, incl. OS & investigator-assessed…
2 days ago

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CSL Reports P-IIIb Trial Data on Andembry for HAE

Shots: CSL has reported topline P-IIIb results evaluating Andembry (garadacimab-gxii) in children aged 2 to 11yrs. with hereditary angioedema (HAE) Pts aged 6–11 years received 100mg (QM, n=16), while those aged 2–5yrs. received 100mg (Q2M, n=6). Andembry showed a favorable safety profile & treatment response, with most pts remaining attack-free over 12mos. Full results will be…
2 days ago

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Akesobio
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Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

Shots: Akeso has dosed the first patient in the P-Ib/II (AK138D1-201) trial assessing AK138D1, as monotx. or in combination with ivonescimab for advanced NSCLC The study will evaluate the regimen across multiple settings in advanced NSCLC, incl. 1L treatment, treatment after EGFR-TKI resistance, & treatment after immuno-CT resistance AK138D1 is a HER3-targeted ADC comprising a…
2 days ago

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Innocare Pharma
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InnoCare Reports P-III Trial Findings on Fadeucravacitinib in Plaque Psoriasis

Shots: InnoCare has reported a P-III trial assessing the efficacy, safety & tolerability of fadeucravacitinib (ICP-488) vs PBO in pts with moderate-to-severe plaque psoriasis Trial met its 1EP with statistically significant & clinically meaningful improvement, while also achieving multiple 2EPs, demonstrating consistent efficacy across measures; data to be presented & published in the future Fadeucravacitinib…
2 days ago

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ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV

Shots: ViiV has reported P-IIIb (VOGUE) study data assessing Dovato (DTG/3TC; n=254) vs Biktarvy (BIC/FTC/TAF; n=255) in 509 treatment-naïve adults living with HIV-1, where treatment was initiated before the availability of baseline resistance testing results At baseline, 47% pts had HIV-1 RNA ≥100,000 copies/mL, 16% had ≥500,000 copies/mL, & 16% had CD4+ counts <200 cells/mm³. At Wk.…
2 days ago

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Astrazeneca and Daiichi-Sankyo New
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Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

Shots: The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157) Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…
3 days ago

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NEWS

argenx to Acquire Forte Biosciences for $2.2B

Shots: argenx has entered into a definitive agreement to acquire Forte Biosciences, strengthening argenx’s innovative immunology portfolio with FB102 As per the deal, argenx will acquire Forte Biosciences for $77/share in cash, representing a total equity value of ~$2.2B; closing is expected in Q3’26 FB102 is an anti-CD122 antibody showing clinical PoC in vitiligo & celiac disease, with…
3 days ago

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NewAmsterdam and Menarini Report the CHMP Positive Opinion for Ubeslo and Evlarco for Primary Hypercholesterolemia

Shots: The CHMP has recommended Ubeslo (obicetrapib 10mg) & Evlarco (10mg obicetrapib + 10mg ezetimibe FDC) for pts with primary hypercholesterolemia, both HeFH & non-familial or mixed dyslipidemia; EC decision expected in H2’26 & will be valid across 30 EEA states Opinion was supported by extensive clinical data assessing obicetrapib, incl. the P-III (BROADWAY, BROOKLYN…
3 days ago

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