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Akesobio
NEWS

Akeso Reports First Patient Dosing in P-III (COMPASSION-33) Trial of Cadonilimab for G/GEJ Adenocarcinoma

Shots: Akeso has enrolled & dosed its first patient with cadonilimab (PD-1/CTLA-4 BsAb) + CT in P-III (AK104-310/COMPASSION-33) trial for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma The P-III (COMPASSION-33) trial in resectable G/GEJ adenocarcinoma pts is designed to improve radical resection rates, lower recurrence & metastasis risk, & improve patient outcomes Additionally,…
August 20, 2025

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Hutchmed
NEWS

HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC

Shots: HUTCHMED has completed enrolment in its P-III (SANOVO) trial to assess Orpathys + Tagrisso as a 1L treatment of pts with locally advanced or metastatic NSCLC harboring EGFR mutation & MET overexpression; last patient was enrolled in Aug 18, 2025 Trial will evaluate Orpathys + Tagrisso vs Tagrisso in NSCLC pts, assessing PFS as 1EP,…
August 20, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 11, 2025 – Aug 14, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Animal Health, and Biosimilars. Check out our full report below:    Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease  Read More: Novartis  Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR)…
August 14, 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

Greywolf Therapeutics Reports First Patient Dosing in P-I/II (EAST-1) Trial of GRWD0715 for Axial Spondyloarthritis

Shots: Greywolf Therapeutics has dosed its first patient with GRWD0715 in P-I/II (EAST-1) trial (n=~141) for the treatment of axial spondyloarthritis (axSpA) The P-I study will assess safety & tolerability of GRWD0715 in ~24 healthy participants & ~36 axSpA pts to utilize the results with proof-of-mechanism data for selecting the active dose for P-II trial…
August 13, 2025

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NEWS

Merck and Pfizer Report Topline P-III (KEYNOTE-905) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-905/EV-303) trial randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed 6 cycles of the combination, then 8 cycles of Keytruda alone) Arms C & B showed improved…
August 12, 2025

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Novartis
NEWS

Novartis Reports Topline P-III (VAYHIT2) Trial Finding on Ianalumab Regimen to Treat Primary Immune Thrombocytopenia (ITP)

Shots: Novartis has reported topline P-III (VAYHIT2) trial data assessing ianalumab (3 or 9mg/kg, QM, IV) + eltrombopag vs PBO + eltrombopag in pts with primary immune thrombocytopenia (ITP) who failed 1L corticosteroid treatment Trial met its 1EP with prolonged time to treatment failure & showed increased sustained platelet count improvement at 6mos. (2EP); data…
August 12, 2025

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Novartis
NEWS

Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease

Shots: Novartis has reported topline P-III (NEPTUNUS-1 & 2) trial data assessing ianalumab (VAY736) in adults with active Sjögren's disease NEPTUNUS-1 assessed ianalumab (300mg, QM) vs PBO in 275 Sjögren's disease pts for 52wks. while NEPTUNUS-2 evaluated ianalumab (300mg; QM or Q3M) vs PBO for up to 52wks. in 504 pts; pts could then either…
August 11, 2025

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