FDA accepts biologics license application for LEQEMBI subcutaneous dosing
- The FDA has accepted Eisai's Biologics License Application for LEQEMBI's subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease.
- The application is based on data from the Clarity AD open-label extension study and modeling of observed data.
- If approved, LEQEMBI will be the only Alzheimer's treatment that can be administered subcutaneously at home using an autoinjector.
- A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025.
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Pheno Therapeutics receives clinical trial authorisation for MS candidate PTD802
- Pheno Therapeutics has been granted clinical trial authorisation by the UK's MHRA for PTD802, a GPR17 antagonist.
- PTD802 is designed to promote remyelination, targeting neurological diseases like multiple sclerosis (MS).
- The approval allows Pheno Therapeutics to progress PTD802 to a Phase 1 trial, marking a significant milestone.
- The trial will be the first to dose a selective GPR17 antagonist in healthy humans, advancing remyelination therapeutics.
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Nxera Pharma updates on Neurocrine's muscarinic agonist portfolio progress
- Neurocrine completed an End of Phase 2 meeting with the FDA for NBI-1117568, planning Phase 3 studies in schizophrenia in 1H 2025.
- Phase 2 studies for NBI-1117568 in bipolar mania and NBI-1117570 in schizophrenia are expected to start in 2H 2025.
- Three other muscarinic agonist programs are in Phase 1 trials with data readouts anticipated in 2025.
- Nxera received a $35 million milestone payment from Neurocrine following positive Phase 2 results for NBI-1117568.
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Regenxbio and Nippon Shinyaku announce exclusive partnership to develop and commercialize RGX-121 and RGX-111 for MPS diseases
- Regenxbio to receive $110 million upfront, with potential milestone payments up to $700 million.
- Nippon Shinyaku to lead commercialization in the U.S. and Asia for RGX-121 and RGX-111.
- Regenxbio retains rights to RGX-121 Priority Review Voucher, with potential FDA approval expected in 2025.
- Regenxbio will lead manufacturing, while Nippon Shinyaku will handle commercialization in the Licensed Territory.
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Dyno Therapeutics licenses AAV vector to Roche for neurological gene therapy
- Roche has exercised its option to license a novel AAV capsid from Dyno Therapeutics for a neurological gene therapy program.
- The license triggers a $7 million payment to Dyno, with potential for over $220 million in milestone payments and royalties.
- This marks the conclusion of the initial collaboration between Dyno and Roche, with a second collaboration announced in October 2024.
- Dyno's platform uses AI to create synthetic AAV capsids with optimized properties for improved gene delivery.
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Vera Therapeutics acquires global rights to novel dual BAFF/APRIL inhibitor
- Vera Therapeutics has secured an exclusive license from Stanford University for VT-109, a next-generation fusion protein targeting BAFF and APRIL.
- VT-109 has potential therapeutic applications across a range of B cell-mediated diseases.
- The agreement includes undisclosed upfront and milestone payments.
- Vera plans to leverage its expertise to advance the development and commercialization of VT-109.
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