Dogwood Therapeutics Announces Commencement of Halneuron® Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study

About this update from Dogwood Therapeutics, Inc.

New study to assess Halneuron® pain reduction effect over three months of treatment, additional safety data to bolster planned end of Phase 2 FDA submission package Patients completing the ongoing Halneuron® 4-week CINP Phase 2b study are now eligible to enroll in the new 12-week open-label follow-on trial ALPHARETTA, Ga., May 18, 2026 (GLOBE NEWSWIRE) -- Dogwood Therapeutics, Inc. (NASDAQ: DWTX) (“Dogwood” or the “Company”), a biopharmaceutical company developing first-in-class, non-opioid medicines to treat pain and neuropathy, today announced commencement of a new Halneuron® chemotherapy induced neuropathic pain (“CINP”) phase 2b extension study. Based on a positive interim assessment demonstrating a Halneuron® 4-week treatment effect versus placebo, Dogwood previously submitted plans to FDA to support commencement of a Halneuron® 12-week follow-on open-label extension study for patients completing the 4-week double-blinded treatment period. Several patients have already been enrolled in the new study that will assess the safety and efficacy of continued Halneuron® treatment for an additional 3 months, using various dosing regimens. Data from the forthcoming extension trial will add to the data package the Company plans to submit to the FDA to support its planned Phase 3 development program, presently projected to start in the first half of 2027. Dogwood Therapeutics previously announced that a pre-planned interim analysis of the double-blinded Halneuron® CINP Phase 2b study supported continuation of the study, with a sample size in the 210-240 range to achieve 80% power. This recommendation by an independent group of statisticians was based on the observed treatment difference between Halneuron®-treated and placebo-treated patients amongst the 97 patients completing the trial. The double-blinded portion of the ongoing CINP study is expected to meet enrollment objectives to support release of top-line results in the fall of 2026. The current overall study dropout rate of under 5% is far below rates typically observed during other FDA-approved chronic pain clinical studies. Patients completing the ongoing CINP Phase 2b trial will be eligible to receive Halneuron® for an additional 12 weeks to control their moderate-to-severe pain following chemotherapy treatment. A review of the demographics of the patients included in the interim analysis revealed that...

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