Dogwood Therapeutics Announces Commencement of Halneuron® Chemotherapy Induced Neuropathic Pain Phase 2b Long Term Extension Study
Rhea-AI Summary
Dogwood Therapeutics (NASDAQ:DWTX) began a 12-week open-label Phase 2b extension study of Halneuron for chemotherapy induced neuropathic pain (CINP). The trial follows a positive interim assessment of a 4-week double-blind study and will collect additional safety and efficacy data.
Interim analysis based on 97 patients supported continuing the Phase 2b trial with a 210–240 patient sample to achieve 80% power. Top-line Phase 2b results are expected in fall 2026, with a Phase 3 program projected to start in the first half of 2027.
Positive
- Phase 2b 12-week Halneuron CINP extension study has commenced
- Interim analysis supported continuing Phase 2b with 210–240 patient sample for 80% power
- Top-line Phase 2b CINP results targeted for release in fall 2026
- Phase 3 Halneuron CINP program projected to begin in first half of 2027
- Overall Phase 2b CINP study dropout rate currently under 5%
Negative
- None.
News Market Reaction – DWTX
In the May 18 session, DWTX declined 7.10%, reflecting a notable negative market reaction. Argus tracked a trough of -19.1% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 14 | Q1 2026 earnings | Positive | +6.5% | Quarterly results, Halneuron® progress, SP16 IND clearance, and cash runway update. |
| May 07 | Earnings date notice | Neutral | -5.5% | Announcement of timing for upcoming Q1 2026 financial results release. |
| Apr 23 | Antiviral partnership | Positive | -8.5% | Global development and commercialization deal for antiviral assets with up to $100M value. |
| Apr 15 | SP16 IND accepted | Positive | -4.5% | FDA acceptance of SP16 IND and NCI-funded Phase 1b CIPPN trial plan. |
| Mar 18 | FY 2025 earnings | Neutral | -7.8% | Full-year 2025 results, Halneuron® interim data, and financing to extend cash runway. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows several positive pipeline or partnership updates followed by negative price reactions, suggesting a tendency for the stock to sell off or fade good news.
Over the last few months, Dogwood has focused on advancing Halneuron® and SP16 while tightening finances. In March 2026, an interim Halneuron® Phase 2b analysis showed separation from placebo and the company completed financing of up to $26.9M. An April 2026 partnership for antiviral assets carried potential value up to $100M. Q1 2026-05-14 results highlighted cash of $13.2M funding operations into Q4 2026. Today’s Phase 2b extension update continues that clinical progression narrative for Halneuron® in CINP.
Key Terms
phase 2b medical
open-label medical
double-blinded medical
chemotherapy induced neuropathic pain medical
fda regulatory
phase 3 medical
neuropathic pain medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
“Neuropathic pain is a difficult to treat chronic condition, as evidenced by the five-year mean duration of symptoms for the patients enrolling in our current Halneuron® CINP Phase 2b trial,” commented R. Michael Gendreau, MD, Chief Medical Officer of Dogwood. “This new 12-week long term extension will generate important additional data on how best to optimize Halneuron® maintenance treatment for our planned Phase 3 program and potential commercialization.”
About Dogwood Therapeutics:
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, Halneuron® and SP16.
Our lead product candidate, Halneuron®, is in Phase 2b development to treat pain conditions including the neuropathic pain associated with chemotherapy treatment. Halneuron® has been granted fast track designation from the FDA for the treatment of CINP. Halneuron® is a non-opioid, NaV 1.7 analgesic which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. In clinical studies, Halneuron® treatment has demonstrated pain reduction in pain related to general cancer and in pain related to chronic chemotherapy-induced neuropathic pain. SP16 IV is a low-density lipoprotein receptor related protein-1 agonist (LRP1) with potential to treat neuropathy and prevent or repair nerve damage following chemotherapy. SP16 acts as an LRP1 agonist that in turn provides alpha-1-antitrypsin-like activity. Consistent with alpha-1-antitrypsin anti-inflammatory and immunomodulatory actions, SP16 preclinically demonstrated anti-inflammatory (analgesic) action via potential reductions in IL-6, IL-8, IL1B and TNF-alpha levels, as well as potential to repair damaged tissue via increases in pAKT and pERK that regulate fundamental processes like growth, proliferation and survival. The forthcoming SP16 IV Phase 1b chemotherapy-induced pain and peripheral neuropathy trial is fully funded by the National Cancer Institute.
Dogwood Therapeutics’ largest shareholder is a member of CK Life Sciences Int’l., (Holdings) Inc., which is listed on the Hong Kong Stock Exchange (Stock code: 0775). For more information, please visit www.dwtx.com.
Forward-Looking Statements:
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Dogwood’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the most recently filed Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law.
Investor Relations:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
