BioSpace News Archive

Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Approvals

Ionis’ Tryngolza Becomes First FDA-Approved Therapy for Familial Chylomicronemia Syndrome

Despite securing the industry’s first approval for familial chylomicronemia syndrome, BMO Capital Markets believes that Tryngolza’s regulatory triumph will not be a significant positive for Ionis. Instead, the firm is focusing on olezarsen’s readout in severe hypertriglyceridemia, a much larger market.

December 20, 2024

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2 min read

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Tristan Manalac

Recession arrow, Graph showing business decline on led screen

MASH

Phase III MASH Miss Sends Galectin Stock Tumbling

Galectin’s shares tanked in premarket trading Friday after the biotech revealed its lead asset missed the primary endpoint for its Phase IIb/III trial for patients with a type of liver cirrhosis.

December 20, 2024

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1 min read

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Kate Goodwin

Corporate headquarters of Novo Nordisk in Denmark

Obesity

Novo Nosedives on Underwhelming CagriSema Phase III Weight-Loss Data

Investors appeared disappointed by CagriSema’s Phase III readout, which showed weight loss that fell short of Novo Nordisk’s prior projections for the therapy. Meanwhile, Eli Lilly’s stock rose on the news.

December 20, 2024

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3 min read

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Tristan Manalac

GSK's headquarters office building in Poznan, Poland

Ovarian cancer

GSK Posts Mixed Survival Data for Jemperli/Zejula Combo in First-Line Ovarian Cancer

First approved in 2021, Jemperli has now become a cornerstone of GSK’s cancer business, earning more than $160 million in the third quarter.

December 20, 2024

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2 min read

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Tristan Manalac

Young businessman jumping through gap cliff at sunrise time with modern city background

GLP-1

Novo’s CagriSema Blunder Underscores Sky-High Investor Expectations for Weight Loss Drugs

Novo Nordisk executives set a high bar for itself when it projected CagriSema could achieve 25% weight loss. When the GLP-1 combo didn’t hit that mark, investors reeled.

December 20, 2024

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3 min read

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Annalee Armstrong

Press Releases

OraSure Technologies Acquires Sherlock Biosciences

December 20, 2024

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9 min read

Press Releases

Cytokinetics Announces Sanofi Acquired Rights to Develop and Commercialize Aficamten in Greater China