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Home » Authors » Lee Landenberger

Articles by Lee Landenberger

IgAN again: Novartis gets second approval in rare kidney disease

April 3, 2025
By Lee Landenberger
The U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. The nod also came without a required safety program through a black box warning.
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Blue heart and data grid

Edgewise down on atrial fibrillation; cardiomyopathy data positive

April 2, 2025
By Lee Landenberger
Top-line data from the second and third parts of Edgewise Therapeutics Inc.’s four-part phase II Cirrus-HCM study in hypertrophic cardiomyopathy (HCM) has produced more positive data. There was however less enthusiasm for the results than there had been in September for the first batch of data.
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Phase III primary endpoint data disappoint Axsome but subgroup beckons

April 1, 2025
By Lee Landenberger

Despite missing the primary endpoint in a phase III study of solriamfetol in major depressive disorder, Axsome Therapeutics Inc. still sees a path to another phase III study. It’s a path some analysts and investors are concerned about, though its precision-medicine approach got plenty of nods of approval.


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3d illustration of ovarian cancer

Corcept looks to NDA following strong phase III ovarian cancer data

March 31, 2025
By Lee Landenberger
Relacorilant, a cortisol modulator from Corcept Therapeutics Inc., produced new and strong phase III results in treating platinum-resistant ovarian cancer. The company also has relacorilant in studies that could eventually lead to approval in other indications. In the near term, though, the positive data led to the company’s stock (NASDAQ:CORT) closing 109% higher at $114.22 per share on March 31.
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Myst it again: Milestone gets a CRL for its heart spray

March 28, 2025
By Lee Landenberger
Milestone Pharmaceuticals Inc.’s heart rhythm-restoring calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) has yet another obstacle in its way. 
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Generic injection pens

In a $2B deal, Novo licenses obesity drug from China’s United Bio

March 25, 2025
By Lee Landenberger
Building upon its already impressive obesity drug portfolio, Novo Nordisk A/S has licensed a triple agonist of the receptors for GLP-1, GIP and glucagon from United Biotechnology Co. Ltd. China-based United is getting $200 million up front and the chance to earn up to $1.8 billion in milestone payments. United Biotechnology retains the rights to subcutaneously administered UBT-251, which is in the early stages of development for treating obesity, type 2 diabetes and other diseases, in China, Hong Kong, Macau and Taiwan while Bagsværd, Denmark-headquartered Novo get exclusive rights to develop, manufacture and commercialize the triple agonist receptor across the rest of the world.
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Heart scientific overlay

For nearly $2B, Jiangsu Hengrui licenses heart drug to Merck

March 25, 2025
By Lee Landenberger
In a deal that could reach nearly $2 billion, Jiangsu Hengrui Pharmaceuticals Co. Ltd. has licensed a small molecule for treating cardiovascular disease to Merck & Co. Inc., dropping the China-based company into a space with lots of competitors in varying stages of development.
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FDA approved icons and medical professional

Have kit, will travel further: Telix PET-imaging agent approved by FDA

March 25, 2025
By Lee Landenberger
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
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Generic injection pens

In a $2B deal, Novo licenses obesity drug from China’s United Bio

March 24, 2025
By Lee Landenberger
Building upon its already impressive obesity drug portfolio, Novo Nordisk A/S has licensed a triple agonist of the receptors for GLP-1, GIP and glucagon from United Biotechnology Co. Ltd. China-based United is getting $200 million up front and the chance to earn up to $1.8 billion in milestone payments. United Biotechnology retains the rights to subcutaneously administered UBT-251, which is in the early stages of development for treating obesity, type 2 diabetes and other diseases, in China, Hong Kong, Macau and Taiwan while Bagsværd, Denmark-headquartered Novo get exclusive rights to develop, manufacture and commercialize the triple agonist receptor across the rest of the world.
Read More
FDA approved icons and medical professional

Have kit, will travel further: Telix PET-imaging agent approved by FDA

March 21, 2025
By Lee Landenberger
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
Read More
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