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Home » Authors » Lee Landenberger

Lee Landenberger

Articles

ARTICLES

Lab mouse

FDA wants a shift away from animal testing

April 11, 2025
By Lee Landenberger
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
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Elderly woman and jigsaw puzzle

Alzheon’s lead candidate misses a phase III in early Alzheimer’s

April 10, 2025
By Lee Landenberger
Alzheon Inc.’s oral treatment for people in the early stages of Alzheimer’s disease missed its phase III primary endpoint, adding yet another therapy to a long list by many developers that can’t beat dementia. The study also received grant money, which is in increasingly short supply.
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More Lexeo data in Friedreich ataxia sees stock slump

April 7, 2025
By Lee Landenberger
Lexeo Therapeutics Inc. produced more positive interim data from early stage studies of its gene therapy to treat Friedreich’s ataxia cardiomyopathy. The results have prompted the company to continue their ongoing dialogue with U.S. FDA regulators to finalize a registrational study protocol and launch that study by early 2026 with data the following year.
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Neurona closes a $102M financing

April 4, 2025
By Lee Landenberger
Neurona Therapeutics Inc. has completed an upsized, oversubscribed $102 million financing round, the third company to do so in a month that’s only four days old. The privately held company’s lead asset is NRTX-1001, a regenerative cell therapy derived from human pluripotent stem cells. 
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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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View All Articles by Lee Landenberger

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