The FDA expanded Fast Track status for invikafusp alfa, Marengo Therapeutics’ TCR Vβ-targeting antibody-IL-2 fusion protein, from TMB-H colorectal cancer to TMB-H solid tumors regardless of tissue of origin.
News|Articles|October 7, 2024
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Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
Mirikizumab (Omvoh) achieved comprehensive disease control in 27.7% of UC patients and deep remission in 20.4% with Crohn disease at 1 year.
The FDA launches a new rare disease development initiative, BioNTech’s BNT113 misses a progression-free survival endpoint, and Viking Therapeutics begins Phase III trials of its oral obesity candidate.
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FDA’s rare disease framework effort will revisit evidence expectations and manufacturing review, with public input starting Oct. 28.
BNT113 plus pembrolizumab failed to significantly extend progression-free survival in a 285-patient HPV16-positive head and neck cancer trial.
Viking Therapeutics has started two Phase 3 trials of once-daily oral VK2735, a dual GLP-1/GIP receptor agonist, in adults with obesity, with and without type 2 diabetes.
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