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Dogwood Therapeutics Files New Synthetic Halneuron(R) Intellectual Property Protection Projected to Extend Exclusivity Period Up to 2045

- New Composition of Matter Intellectual Property ("IP") Filing Centered on First-in-Class, Fully Synthetically Manufactured Halneuron®- - New Synthetic Process to be Used for Phase 3 Development Provides Higher Manufacturing Yields and Reduces ...

articleDogwood Therapeutics, Inc.December 2, 20254/company/dogwood-therapeutics-inc/news/dogwood-therapeutics-files-synthetic-halneuron-130000818
Dogwood Therapeutics Files New Synthetic Halneuron(R) Intellectual Property Protection Projected to Extend Exclusivity Period Up to 2045

About this update from Dogwood Therapeutics, Inc.

[{"type":"text","content":"- New Composition of Matter Intellectual Property ("IP") Filing Centered on First-in-Class, Fully Synthetically Manufactured Halneuron®-","length":154,"tagName":"p"},{"type":"text","content":"- New Synthetic Process to be Used for Phase 3 Development Provides Higher Manufacturing Yields and Reduces Costs Versus Naturally Harvested Halneuron® -","length":161,"tagName":"p"},{"type":"text","content":"ATLANTA, GA / ACCESS Newswire / December 2, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a development-stage biotechnology company developing new medicines to treat pain and neuropathy, today announced it has filed for new intellectual property protection for synthetic Halneuron®. If granted, the IP's exclusivity period will extend to 2045, before additional patent term restoration extensions.","length":430,"tagName":"p"},{"type":"text","content":""We plan to use synthetically manufactured Halneuron® in both Phase 3 development and commercialization," said Greg Duncan, Dogwood Therapeutics Chief Executive Officer. "This new synthetic process builds on our proprietary and best-in-class manufacturing know-how, with potential to reset our exclusivity period for 20 years, thus providing ample opportunity to deliver Halneuron's® full commercial potential."","length":435,"tagName":"p"},{"type":"text","content":"About Halneuron®","length":16,"tagName":"p"},{"type":"text","content":"Our lead product candidate, Halneuron®, is in Phase 2b development as a non-opioid, NaV 1.7 inhibitor to treat pain conditions including the neuropathic pain associated with chemotherapy treatment ("CINP"). Halneuron® has been granted fast track designation from the Food and Drug Administration ("FDA") for the treatment of CINP. Success in this Phase 2b study will serve as the basis for the Company engaging the FDA to align on the Halneuron® Phase 3 development program requirements.","length":507,"tagName":"p"},{"type":"text","content":"About Dogwood Therapeutics","length":26,"tagName":"p"},{"type":"text","content":"Dogwood Therapeutics (Nasdaq:DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and neuropathic disorders. The Dogwood research pipeline includes two first-in-class development candidates, Halneuro...

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