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BioWorld - Tuesday, February 3, 2026
Home » Topics » Clinical

Clinical
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Transparent capsule with DNA and cells

Gene therapy efforts active, despite low Bluebird, 2seventy bids

March 14, 2025
By Karen Carey
Bristol Myers Squibb Co.’s decision this week to snag Bluebird Bio Inc. spinout 2seventy Bio Inc. for $102 million net – just weeks after investors bid $30 million for Bluebird itself – seemed to place a final blow on what was once a promising gene therapy company. The space in general has struggled to make business sense out of the one-time therapies that often involve complicated manufacturing and exorbitant prices, despite the life-changing value that gene therapies bring to patients. But despite some recent setbacks, biopharmas continue to plow forward with promising research in the field.
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Liver illustration

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

March 11, 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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Cervomed serves up positive extension data in dementia phase IIb study

March 11, 2025
By Lee Landenberger
Positive 16-week extension data from Cervomed Inc.’s phase IIb in dementia with Lewy bodies followed a failure from December. New results from the Rewind-LB trial testing neflamapimod, a brain-penetrant, orally administered small molecule that inhibits the intracellular enzyme p38MAP kinase alpha, have encouraged the company to pursue a phase III study.
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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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