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BioWorld - Thursday, July 9, 2026
Home » Topics » Clinical

Clinical
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Breast cancer illustration

Arvinas phase III wild card turns over in breast cancer

March 11, 2025
By Randy Osborne
Mixed clinical results led shares of Arvinas Inc. (NASDAQ:ARVN) to close March 11 at $8.30, down $9.26, or 52%, after the company and Pfizer Inc. disclosed results from the phase III Veritac-2 study testing vepdegestrant monotherapy vs. fulvestrant in adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Enrolled were subjects whose disease progressed after treatment with CDK4/6 inhibitors and endocrine therapy.
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Sooma device with laptop

Sooma receives IDE for neurostimulation therapy for depression

March 11, 2025
By Shani Alexander
Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct current stimulation medical device in people with major depressive disorder. The study will examine the efficacy of the non-invasive Sooma 2Gen device in improving MDD as an at-home treatment.
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Medtronic Prevail

SCAAR data Prevails for Medtronic paclitaxel-coated balloon

March 11, 2025
By Holland Johnson
Medtronic plc reported results from a registry highlighting the effectiveness of the Prevail paclitaxel-coated balloon. The findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) were presented by Sacharias von Koch of the department of cardiology and clinical sciences at Lund University, Skåne University Hospital in Sweden at the Cardiovascular Research Technologies 2025 meeting in Washington.
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Skin irritation on hands

Kyowa Kirin, Amgen’s rocatinlimab ignites positive response in Rocket study

March 11, 2025
By Tamra Sami
Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis.
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Green and red bispecific antibodies

(Bi-)specific gravity: Bambusa, others serious about approach

March 10, 2025
By Randy Osborne
The recent series A financing by Bambusa Therapeutics Inc. to fund bispecific antibodies for immunological and inflammatory disorders proved investor faith in the new approach with a proven mechanism.
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Blood pressure cuff

Mineralys sees a double drop in blood pressure and a stock pop

March 10, 2025
By Lee Landenberger
Positive top-line data from phase II and III studies of lorundrostat for treating uncontrolled or resistant hypertension propelled Mineralys Therapeutics Inc.’s stock sharply upward on March 10. The phase III Launch-HTN study hit its primary endpoint in reducing systolic blood pressure and the phase II Advance-HTN study also met its primary endpoint of a clinically meaningful reduction in blood pressure. Oral lorundrostat targets dysregulated mineralcorticoid aldosterone as a selective aldosterone synthase inhibitor. Mineralys estimated there to be about 15- to 20-million patients with uncontrolled hypertension in the U.S. On March 10, the Radnor, Pa.-based company’s shares (NASDAQ:MLYS) closed 42% upward at $14.96 each.
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Evolut device image

Medtronic sees SMART TAVR results in small aortic annulus patients

March 10, 2025
By Holland Johnson
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.
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Liver illustration

MASH field still hot as Boehringer axes $870M deal with Yuhan

March 7, 2025
By Marian (YoonJee) Chu
Boehringer Ingelheim GmbH terminated its second metabolic dysfunction-associated steatohepatitis (MASH) alliance on March 6, ending an $870 million license agreement inked with Yuhan Corp. for dual GLP-1/FGF21 agonist, BI-3006337 (YH-25724). Yuhan said March 7 that Boehringer, of Ingelheim, Germany, returned rights to YH-25724, a dual-acting glucagon-like peptide-1 and fibroblast growth factor 21 receptor agonist, based on the counterparty’s “strategic judgement” on developing MASH therapeutics.
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Polycythemia vera illustration

Protagonist’s rusfertide hits phase III goals in rare leukemia

March 5, 2025
By Marian (YoonJee) Chu
Rusfertide could become a blockbuster therapy for polycythemia vera, H.C. Wainwright analyst Douglas Tsao wrote March 4 after the injectable hepcidin mimetic peptide hit its primary endpoint and all four key secondary endpoints in the ongoing phase III Verify study.
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Back pain

Persica’s PP-353 wins in back pain, advances to phase III

March 5, 2025
By Nuala Moran
Persica Pharmaceuticals Ltd. has delivered positive 12-month follow-up data from its phase Ib study of PP-353, an injectable antibiotic for treating chronic lower back pain, and is now looking for a partner and further financing to take the product into phase III development.
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