Kyntra Bio Presents New Roxadustat Data on Improvements in Transfusion Independence Regardless of Ring Sideroblast Status in Patients with Anemia due to Lower-Risk Myelodysplastic Syndromes
Rhea-AI Summary
Kyntra Bio (Nasdaq: KYNB) reported new post hoc Phase 3 MATTERHORN data for roxadustat in anemia due to lower-risk MDS. Roxadustat improved transfusion independence versus placebo, with similar benefits in ring sideroblast positive and negative disease, and higher TI rates in high transfusion burden patients. TEAEs were mostly lower grade with no new safety signals, and a pivotal Phase 3 trial is planned to start in 2H 2026 after FDA feedback.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Positive
- Overall MATTERHORN: 48% transfusion independence with roxadustat vs 33% with placebo
- RS- subgroup: 48% achieved ≥8-week TI over 28 weeks vs 28% placebo
- High transfusion burden subgroup (n=37) showed higher ≥8-,12-,16-week TI rates vs placebo
- TEAEs generally lower grade, medically managed, with no new safety signals reported
- Pivotal Phase 3 trial protocol finalized based on FDA feedback
Negative
- Key MATTERHORN efficacy findings are derived from post hoc analyses
- Pivotal Phase 3 roxadustat trial for LR-MDS and high transfusion burden has not yet initiated, targeted for 2H 2026
News Market Reaction – KYNB
On the day this news was published, KYNB gained 4.14%, reflecting a moderate positive market reaction. Argus tracked a peak move of +10.5% during that session. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $32.06M at that time. Trading volume was exceptionally heavy at 28.3x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 11 | Earnings and pipeline | Positive | +6.3% | Q1 2026 results, narrowed loss, cash runway and roxadustat Phase 3 plans. |
| May 04 | Earnings date set | Neutral | -1.4% | Announcement of upcoming Q1 2026 results call and webcast schedule. |
| Apr 08 | Conference appearance | Neutral | -1.5% | Plan to present at Needham Virtual Healthcare Conference with webcast access. |
| Mar 16 | Earnings and update | Positive | +5.3% | Q4/FY2025 results plus FG‑3246 data and roxadustat Phase 3 protocol submission. |
| Mar 09 | Earnings date set | Neutral | +7.3% | Scheduling announcement for Q4/FY2025 earnings release and business update call. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Price often reacted strongly to both earnings and neutral scheduling news, with several instances where modest or neutral headlines led to notable moves in either direction.
Over the last few months, Kyntra Bio has focused on financial updates and pipeline progress. Earnings reports on Mar 16, 2026 and May 11, 2026 highlighted advancing FG-3246 trials and plans for a pivotal Phase 3 roxadustat study in LR‑MDS, with share price gains of 5.29% and 6.25%. Even neutral items like earnings date announcements and a Needham conference appearance saw moves between about -1.5% and +7.3%, indicating the stock has been sensitive to news flow as development milestones approach.
Regulatory & Risk Context
Key Terms
post hoc analysis medical
ring sideroblast medical
myelodysplastic syndromes medical
transfusion independence medical
high transfusion burden medical
TEAEs medical
pRBCs medical
Phase 3 trial medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- In a post hoc analysis, patients treated with roxadustat showed a durable and clinically meaningful improvement in transfusion independence (TI) in patients with LR-MDS and high transfusion burden (HTB) compared to placebo
- Similar rates of TI for patients treated with roxadustat were observed in both ring sideroblast positive (RS+) and ring sideroblast negative (RS-) disease
- Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the Food and Drug Administration (FDA)
SAN FRANCISCO, June 11, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today announced additional data from the Phase 3 MATTERHORN trial showing improvements in transfusion independence in patients with anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) treated with roxadustat will be presented as a poster at the European Hematology Association (EHA) Congress 2026, taking place June 11-14, 2026 in Stockholm, Sweden.
“In addition to roxadustat demonstrating clinically meaningful efficacy in patients with lower-risk MDS and high transfusion burden, improvements in transfusion independence in both RS+ and RS- disease were also observed in this post-hoc analysis, which is an important finding given the limited effectiveness of currently available treatment options for patients with RS- disease,” said Thane Wettig, Chief Executive Officer of Kyntra Bio. “These findings underscore the potential of roxadustat to elevate the standard of care for patients with lower-risk MDS who are in need of additional treatment options. We are finalizing the protocol for the pivotal Phase 3 trial, which we expect to initiate in the second half of 2026, with the aim to build upon and confirm these findings in patients with lower-risk MDS and high transfusion burden, including both RS+ and RS- disease.”
“Through this novel MOA, stabilizing HIF1-⍺, thereby normalizing erythroid precursor development and improving hemoglobin production, these findings highlight the potential for roxadustat to address a significant unmet need, providing a convenient, well-tolerated and effective treatment option for anemia in patients with LR-MDS independent of RS histology,” said Amer Zeidan, MD, Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center. “This post-hoc analysis from the MATTERHORN trial shows clinically meaningful RBC transfusion independence among high transfusion burden patients, as well as clear evidence of hemoglobin increase among patients who received roxadustat compared to placebo. I am excited to be able to share this data with the MDS community at the EHA meeting and believe they provide strong rationale for the planned randomized Phase 3 trial in anemic patients with LR-MDS and high RBC transfusion burden,” concluded Dr. Zeidan, who is also the global principal investigator of the planned randomized Phase 3 trial.
As previously disclosed, the initial analysis with all of the patients who participated in the Phase 3 MATTERHORN trial showed that more patients receiving roxadustat achieved transfusion independence vs. placebo (
The presentation at EHA also provides additional details on the subgroup of patients (n=37) who met the criteria of HTB (≥ 4 units pRBCs per 8-week period for 2 consecutive 8-week periods) per IWG-2018, where roxadustat achieved clinically meaningful efficacy in patients with LR-MDS and HTB with higher rates of ≥8-, 12-, 16-week RBC TI vs placebo. TEAEs were generally lower grade and managed medically with no new safety signals.
The poster presentation, titled “Roxadustat improves transfusion independence in LR-MDS patients with anemia and high transfusion burden and in ring sideroblast positive and negative disease: post-hoc analysis of MATTERHORN study” is scheduled for the poster session taking place on June 12, 2026 at 18:45 CEST.
The pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA.
About Myelodysplastic Syndromes Anemia
Myelodysplastic syndromes (MDS) are a group of disorders characterized by dysfunctional progenitor blood cells and stem cells, resulting in chronic anemia in most patients. Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S., thereof
About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.
Roxadustat is approved in Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.
About Kyntra Bio
Kyntra Bio is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in Europe, Japan, China, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.kyntrabio.com.
Note: Amer Zeidan’s views are his own personal views and do not necessarily represent his employer’s views. He has also consulted and received honoraria and travel support from Kyntra Bio.
Forward-Looking Statements
This release contains forward-looking statements regarding Kyntra Bio’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs . These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and product candidates, and statements about Kyntra Bio’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Kyntra Bio’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in Kyntra Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Kyntra Bio undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@kyntrabio.com
