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Home » Authors » Karen Carey

Articles by Karen Carey

Coya sinks on phase II Alzheimer’s data, advances combo strategy

Oct. 29, 2024
By Karen Carey
While phase II results of Coya Therapeutics Inc.’s low-dose IL-2 drug, COYA-301, showed promise in Alzheimer’s disease patients when dosed every four weeks, it was the more frequent dosing of every two weeks that led to exhausted regulatory T cells and no benefits, driving down the company’s stock by nearly 28%.
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Marinus tanks on ganaxolone miss; all development ends

Oct. 24, 2024
By Karen Carey
For a company that was running out of money, a missed phase III endpoint for its only development product knelled a death blow for Marinus Pharmaceuticals Inc., tanking its stock by 82%. The Radnor, Pa.-based company will no longer develop oral ganaxolone for seizures associated with tuberous sclerosis complex, or for any other indication, as it reduces its workforce and explores strategic alternatives.
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FDA issues CRL: Inspection woes hold up Camurus’ acromegaly drug

Oct. 22, 2024
By Karen Carey
Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
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US FDA issues first-in-class and first-line approval for Astellas’ Vyloy

Oct. 22, 2024
By Karen Carey
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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US FDA issues first-in-class and first-line approval for Astellas’ Vyloy

Oct. 18, 2024
By Karen Carey
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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Topas’ platform validated with top-line celiac disease data

Oct. 15, 2024
By Karen Carey
Securing clinical proof of concept for its nanoparticle platform, Topas Therapeutics GmbH reported promising top-line phase IIa results of TPM-502 for celiac disease. Results show a clear statistically significant dose response for antigen-specific markers of tolerance. The effects persisted throughout the follow-up period, and the candidate was safe at all doses tested, according to the Hamburg, Germany-based company.
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IPO, coins, financial chart

Septerna joins IPO queue; 23 biopharma debuts reach $5.9B

Oct. 3, 2024
By Karen Carey
South San Francisco-based Septerna Inc. filed an S-1 with the U.S. SEC to conduct an IPO on Nasdaq about two years and eight months after launching operations with a $100 million series A led by Third Rock Ventures. The company is focused on G protein-coupled receptor oral small molecules derived from its Native Complex Platform, aimed at treating diseases within the endocrinology, immunology and inflammation, and metabolic diseases realms.
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Ron Renaud, CEO, Kailera
Newco news

Kailera launches with $400M series A, Hengrui’s metabolic assets

Oct. 1, 2024
By Karen Carey
In one of the top series A financings in biopharma history, new company Kailera Therapeutics Inc. emerged with $400 million raised and a pipeline of next-generation assets to treat obesity and type 2 diabetes.
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Kezar halts lupus nephritis trial on four fatalities

Oct. 1, 2024
By Karen Carey
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
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Kezar halts lupus nephritis trial on four fatalities

Sep. 30, 2024
By Karen Carey
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
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