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Home » Topics » Clinical

Clinical
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Health professional pointing stethoscope at Clinical Trial words, icons
Biopharma clinical updates April 2025

Axsome's solriamfetol shows mixed results amid 13 phase III wins in April

May 27, 2025
By Amanda Lanier
No Comments
BioWorld recorded 151 clinical trial updates from phases I through III in April 2025, a drop from 197 in March. The month saw 13 successful phase III readouts, alongside four failed trials and two with mixed results.
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Prothena sinks on phase III miss in amyloidosis

May 27, 2025
By Nuala Moran
No Comments
History has repeated itself for Prothena Corp. plc, which has reported a second phase III miss for birtamimab in the treatment of light chain amyloidosis. Announcing the trial failure, the Dublin-based company said it is planning “a substantial reduction” of its organization.
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Heart and DNA

Houston, a problem: Rocket death in Danon stalls phase II program

May 27, 2025
By Randy Osborne
No Comments
Rocket Pharmaceuticals Inc. CEO Gaurav Shah said his firm is investigating how its gene therapy for Danon disease may have created an “unexpected and paradoxical” effect that led to problems for a phase II patient who ultimately died.
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Device in heart
EuroPCR 2025

Edwards' data shows benefits of early intervention in aortic stenosis

May 23, 2025
By Shani Alexander
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
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Antibody-drug conjugate

Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

May 23, 2025
By Nuala Moran
No Comments
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
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Imunon ovarian cancer prospect impresses with survival benefits

May 23, 2025
By Karen Carey
No Comments
Imunon Inc. soared by 179% on the heels of phase II Ovation 2 data showing that its IMNN-001 immunotherapy led to a 13-month increase in overall survival among women with ovarian cancer. Patients in the intent-to-treat population, receiving the drug plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT), achieved median overall survival (OS) at 46 months vs. 33 months with N/ACT alone. Increased activity was seen among patients treated with poly ADP-ribose polymerase inhibitors, with the median OS not yet reached after more than five years vs. 37 months in the control arm.
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Woman holding neck

Merus combo trounces Keytruda in head-and-neck phase II

May 23, 2025
By Randy Osborne
No Comments
Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date.
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TRiCaresTopaz
EuroPCR 2025

Tricares Topaz valve significantly reduces tricuspid regurgitation

May 22, 2025
By Shani Alexander
Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz were at a TR grade ‘none’ (0+) or ‘mild’ (1+) following the procedure.
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Annji's phase I/II positive in spinal, bulbar muscular atrophy

May 22, 2025
By Tamra Sami
No Comments
Annji Pharmaceutical Co. Ltd.’s rosolutamide (AJ-201, JM-17) achieved positive results in a phase I/II trial in adults with spinal and bulbar muscular atrophy, also known as Kennedy’s disease.
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3-30-Medtronic-Symplicity-Spyral.png
EuroPCR 2025

Medtronic reveals data on benefits of RDN system

May 21, 2025
By Shani Alexander
Medtronic plc revealed data at the EuroPCR conference which showed there was a significant, safe and sustained blood pressure reduction in patients treated with its Spyral renal denervation system who meet European recommended guidelines criteria over a three-year period.
Read More
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