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BioWorld - Friday, March 13, 2026
Home » Topics » U.S., BioWorld Asia

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Australian coins and bills

Kazia raises AU$50M to advance PI3K/mTOR inhibitor paxalisib

Dec. 9, 2025
By Tamra Sami
No Comments
Kazia Therapeutics Ltd. raised AU$50 million (US$33.15 million) in a private placement of equity securities to advance lead candidate paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in clinical trials for brain cancer and advanced breast cancer.
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Green and red bispecific antibodies

Crescent, Kelun in two-way deal, including PD-1/VEGF bispecific

Dec. 9, 2025
By Marian (YoonJee) Chu
No Comments
Crescent Biopharma Inc. teamed with Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. to generate “parallel” data of its PD-1/VEGF bispecific antibody, CR-001. The goal is to get 2027 readouts of the bispecific as a monotherapy and as a combination therapy with antibody-drug conjugates in both the U.S. and China.
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Pfizer adds heft to obesity pipeline in $2B Yaopharma deal

Dec. 9, 2025
No Comments
A month after besting rival Novo Nordisk A/S in a bidding war for obesity drug developer Metsera Inc., Pfizer Inc. is again adding to its GLP-1 arsenal, this time via a $2 billion licensing and collaboration agreement with Yaopharma, a subsidiary of China’s Fosun Pharmaceutical Co. Ltd.
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Kidneys

Otsuka’s IgAN therapy gets a thumbs-up from the FDA

Dec. 2, 2025
By Lee Landenberger
No Comments
The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
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Otsuka submits NDA for new non-stimulant ADHD therapy

Nov. 25, 2025
By Tamra Sami
No Comments
Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
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Doctors examining lung scans

Taiho, Cullinan file rolling NDA on phase I/II zipalertinib data

Nov. 25, 2025
By Tamra Sami
No Comments
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
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Komzifti packaging

FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML

Nov. 18, 2025
By Tamra Sami
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
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FDA Approved stamp

Henlius, Organon win US FDA approval of first Perjeta biosimilar

Nov. 18, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
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Deal handshake with coin, chart background

ABL Bio’s Grabody lands second $2.6B deal, this time with Lilly

Nov. 13, 2025
By Marian (YoonJee) Chu
No Comments
ABL Bio Inc. inked a license and research agreement with Eli Lilly and Co. worth up to $2.6 billion to develop multiple therapeutics using the Grabody-B platform. Under the terms announced Nov. 12, ABL will receive a $40 million up-front payment and up to $2.56 billion in development, regulatory and commercialization milestones, plus tiered royalties on net sales.
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Illustration of antibodies flying around a kidney

Takeda’s mezagitamab shows lasting kidney function in IgA nephropathy

Nov. 11, 2025
By Tamra Sami
No Comments
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
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