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NEWS

Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots: The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…
August 28, 2025

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Regeneron New
NEWS

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussions Trial met its 1EP of improved MG-ADL total score, showing…
August 27, 2025

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NEWS

Merz Therapeutics Enrolls First Patients in P-III Studies Evaluating Xeomin for Migraine Prevention

Shots: Merz Therapeutics has enrolled the first patients in two global P-III studies, MINT-E (episodic migraine, ~990 pts) and MINT-C (chronic migraine, ~780 pts), evaluating the efficacy and safety of Xeomin (incobotulinumtoxinA) for migraine prevention Both studies will recruit ~1,770 adults across 120 sites in North America & Europe, and recruitment in Europe is expected…
August 26, 2025

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Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots
VIEWPOINTS

Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots

Shots:  Jazz Pharmaceuticals and partners presented seven abstracts from their oncology development program at ASCO 2025   Robert Iannone, EVP, Global Head of Research and Development, and Chief Medical Officer at Jazz Pharmaceuticals, in an engaging discussion with PharmaShots, shared insights from the P-III IMforte trial assessing Zepzelca plus atezolizumab in first-line maintenance treatment for Extensive…
August 25, 2025

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Argenx
NEWS

argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

Shots: argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG) Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of…
August 25, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 18, 2025 – Aug 22, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, and Biosimilars. Check out our full report below:    HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC  Read More: HUTCHMED  Akeso Reports First Patient Dosing in P-III (COMPASSION-33) Trial of Cadonilimab for…
August 22, 2025

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NEWS

Tyra Biosciences Doses First Patient in P-II (BEACH301) Trial of Dabogratinib to Treat Achondroplasia

Shots: Tyra Biosciences has dosed its first patient with dabogratinib (FGFR3 inhibitor) in P-II (BEACH301) trial for the treatment achondroplasia Trial will evaluate dabogratinib in children (3–10 yrs) with achondroplasia & open growth plates across 2 cohorts: treatment-naïve & previously treated with growth-accelerating therapy, enrolling up to 10 pts per dose level (0.125, 0.25, 0.375…
August 22, 2025

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