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BioWorld - Tuesday, February 10, 2026
Home » Topics » Regulatory » NDA

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Glass of water and tablets

Genentech plans NDA for multiple sclerosis pill with study win

Feb. 10, 2026
By Marian (YoonJee) Chu
No Comments
Genentech Inc. is covering more bases in multiple sclerosis, with its latest swing on fenebrutinib hitting a rare phase III noninferiority win against Ocrevus (ocrelizumab) in primary progressive multiple sclerosis.
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Hair loss drugmaker Veradermics floats upsized $256M US IPO

Feb. 4, 2026
By Marian (YoonJee) Chu
No Comments
Veradermics Inc. raised $256.3 million from an IPO on the New York Stock Exchange Feb. 4. The proceeds will fund three ongoing phase II/III clinical trials of VDPHL-01, its novel oral formulation of Rogaine (minoxidil) to treat pattern hair loss in men and women.
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Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
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Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Jan. 30, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
Read More
Liver illustration

China accepts Hutchmed fanregratinib NDA on single phase II trial

Dec. 30, 2025
By Tamra Sami
No Comments
Hutchmed (China) Ltd. has moved closer to establishing China’s first domestically developed FGFR-targeted therapy for intrahepatic cholangiocarcinoma, after the National Medical Products Administration (NMPA) accepted its NDA for fanregratinib (HMPL-453) and granted the drug priority review.
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Immunome’s phase III results in desmoid tumors point to NDA

Dec. 15, 2025
By Lee Landenberger
No Comments
Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. The small molecule produced a statistically significant and clinically meaningful improvement vs. placebo with its 84% reduction in the risk of disease progression or death.
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14 psoriasis therapies projected to launch in China by 2027

Dec. 8, 2025
By Marian (YoonJee) Chu
No Comments
Fourteen therapies to treat moderate to severe psoriasis are expected to enter the Chinese market in the next two years, according to Clarivate and BioWorld reports. Eleven of them are being developed by domestic biopharmaceutical firms.
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Stomach cross-section on scientific background

A second win for Cogent pushes the company toward two NDAs

Nov. 10, 2025
By Lee Landenberger
No Comments
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
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Illustration of nasopharyngeal carcinoma

Lepu’s MRG-003 cleared as China’s first EGFR ADC for advanced NPC

Nov. 4, 2025
By Marian (YoonJee) Chu
No Comments
Lepu Biopharma Co. Ltd. said Oct. 30 it won Chinese approval of a novel antibody-drug conjugate (ADC), Meiyouheng (becotatug vedotin injection), making it China’s first epidermal growth factor receptor (EGFR)-directed ADC for advanced nasopharyngeal cancer (NPC).
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Chris Lai, cofounder and CEO, Metis at Nanoforge launch

Metis plans China NDA submission for orally dissolving PBA drug

Oct. 28, 2025
By Marian (YoonJee) Chu
No Comments
Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
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