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BioWorld - Wednesday, July 8, 2026
Home » chronic spontaneous urticaria

Articles Tagged with ''chronic spontaneous urticaria''

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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Red wooden approved stamp

Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar

May 28, 2024
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
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Red wooden approved stamp

Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar

May 24, 2024
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
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Celltrion files for US approval of Xolair biosimilar, CT-P39

March 12, 2024
By Marian (YoonJee) Chu
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
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Celltrion files for US approval of Xolair biosimilar, CT-P39

March 11, 2024
By Marian (YoonJee) Chu
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
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Layoff, shutdown illustration

Lirentelimab out on failed phase II data; Allakos restructures

Jan. 16, 2024
By Karen Carey
Allakos Inc. terminated all development of its lead drug, anti-Siglec-8 antibody lirentelimab (AK-002), and is cutting its workforce in half, following phase II failures for atopic dermatitis and chronic spontaneous urticaria. The San Carlos, Calif.-based company will now focus on phase I trials for anti-Siglec-6 antibody AK-006 as part of a restructuring that stretches the runway into mid-2026. Shares (NASDAQ:ALLK) sank by 60.2%, down $1.80, to close at $1.19 on Jan. 16.
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Woman scratching hives on shoulder

Phase III readout with Novartis’ chronic hives contender offers s-liver of hope for BTK class

Aug. 9, 2023
By Caroline Richards
There have been no signs of liver damage with Novartis AG’s oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib for treating chronic spontaneous urticaria, top-line results from two phase III trials show, suggesting that faith in the faltering BTK space could be restored.
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Mast cell releasing histamine during allergic response
Inflammatory

Third Harmonic Bio announces next-generation oral KIT inhibitor for inflammatory diseases

July 26, 2023
Third Harmonic Bio Inc. has announced a new product candidate, THB-335, a potent, highly selective, oral, small-molecule KIT inhibitor.
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