On June 11, 2026 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported updated positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML). An oral presentation will be delivered later today at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place June 11-15 in Stockholm, Sweden, and virtually. The Company also provided an update on recent regulatory interactions with the Food and Drug Administration (FDA). Enliven will host a webcast and conference call today, June 11, at 8:30 a.m. ET / 2:30 p.m. CEST.

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"Despite recent advances in CML treatment, there remains a need for highly effective therapies with excellent safety and tolerability profiles optimized for long-term treatment and capable of deep and durable molecular responses," said Dennis Kim, M.D., Professor of Medicine in the Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. "The updated data from the ENABLE trial are very promising and encouraging. The trial demonstrated meaningful responses across lines of therapy in heavily pretreated patients, including responses in patients who had shown a lack of efficacy to the most effective approved therapies. Further, ELVN-001 demonstrated a favorable safety and tolerability profile, reflecting its high selectivity. I look forward to the initiation of the planned Phase 3 ENABLE-2 trial, which could establish ELVN-001 as an important new treatment option for patients with previously treated CML."

"These promising results continue to showcase the consistency of ELVN-001’s overall profile and reinforce its potential to be a best-in-class ATP-competitive inhibitor with differentiated activity relative to allosteric inhibitors," said Helen Collins, M.D., Chief Medical Officer of Enliven. "In these data, we observed higher response rates in patients treated in earlier lines of therapy, and comparable response rates regardless of prior asciminib exposure. We are also thrilled by the outcome of our recent End-of-Phase 1 meeting with the FDA, where we reached alignment on the 80 mg once daily dose and the inclusion of patients who have received at least one prior TKI in the planned ENABLE-2 Phase 3 trial. This is an important milestone as we advance towards initiating ENABLE-2 later this year."

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. Data presented at EHA (Free EHA Whitepaper) are from the ongoing ENABLE Phase 1 clinical trial, which enrolled patients with CML that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).

ELVN-001 Updated Data Highlights

ENABLE Has Enrolled a Heavily Pretreated Patient Population

As of the cutoff date of March 10, 2026, 161 patients were enrolled in the ongoing Phase 1 trial across dose levels ranging from 10-240 mg daily.
Most patients (76%) remain on study with a median treatment duration of 35 weeks.
Patients enrolled were heavily pretreated, with 70% having received three or more prior unique TKIs and 23% having received five or more unique TKIs.
62% of patients received prior asciminib, and these patients were more heavily pretreated than the overall trial population: 93% received three or more prior unique TKIs, and 34% received five or more unique TKIs.
8% of patients enrolled with mutations associated with resistance to allosteric inhibitors, increasing from 4% in Phase 1a to 11% in Phase 1b.
Encouraging ELVN-001 Efficacy Data by 24 Weeks

Of the 90 patients enrolled in the Phase 1b, 78 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 69 patients were evaluable for major molecular response (MMR) by 24 weeks.
Additionally, of the 49 patients enrolled in the 80 mg once daily (QD) Phase 1b cohort, 37 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 28 patients were evaluable for MMR by 24 weeks.
Cohort (n = evaluable for MMR)

Phase 1b

Phase 1b 80 mg QD
Cohort

Overall MMR

54% (n=69)

61% (n=28)

Achieved MMR

40% (n=53)

48% (n=21)

Maintained MMR

100% (n=16)

100% (n=7)

Deep Molecular Response (DMR) achievement rates were also encouraging.
By 24 weeks, DMR was achieved in 22% of patients in the overall Phase 1b and 30% of patients in the 80 mg QD Phase 1b cohort.
Response rates were higher in less heavily pretreated patients, and prior asciminib exposure did not meaningfully impact response rates.
Achieved Response Rates by 24-weeks (n = evaluable for MMR)

Prior number of unique TKIs:

Phase 1b (n=69)

Phase 1b post-asciminib (n=43)

1-2

55% (n=27)

60% (n=6)

3-4

32% (n=26)

28% (n=22)

5+

29% (n=16)

29% (n=15)

ELVN-001’s Safety Profile Consistent with High Selectivity for ABL1

ELVN-001 was generally well-tolerated, consistent with its high selectivity.
6% of patients discontinued due to adverse events.
The majority of treatment-emergent adverse events (TEAEs) were Grade 1 or 2.
Grade ≥3 TEAEs were reported in 53/158 (34%) patients overall; with thrombocytopenia (6%), neutropenia (6%) and lipase elevation (6%) as the most common.
At the biologically optimal dose of 80 mg QD (n=62), Grade ≥3 TEAEs were reported in 15/62 (24%) patients, with thrombocytopenia (6%) being the only Grade ≥3 TEAE reported in >5% of patients.
Key Outcomes from the End-of-Phase 1 Meeting with the FDA

80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial.
ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician’s choice of an ATP-competitive TKI.
Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.
The oral presentation titled: "ENABLE: Updated Efficacy and Safety Results of ELVN-001, a Novel Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients with Previously Treated CP-CML" will be presented today at 5:45 p.m. CEST during the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden, by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. A copy of the presentation will be available on the "Program Presentations & Publications" section of the Company’s website at www.enliventherapeutics.com.

Webcast and Conference Call Information
Enliven will host a live webcast and conference call today at 8:30 a.m. ET / 2:30 p.m. CEST. To participate in the live event, please register using this link. Following registration, participants will have access to dial in numbers and a unique passcode should they prefer to participate by phone. The event and accompanying slides can also be accessed by visiting the investor relations section of the Company’s website at View Source An archived webcast will be available on the Company’s website following the event.

About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.

About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. ELVN-001, a highly selective active-site TKI, has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

(Press release, Enliven Therapeutics, JUN 11, 2026, View Source [SID1234666582])

On June 11, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, reported that it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 1,363,638 shares (the "Shares") of its common stock, par value $0.18 per share ("Common Stock") (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 1,363,638 shares of Common Stock and short-term Series B warrants to purchase up to 1,363,638 shares of Common Stock (such warrants, collectively, the "Series Warrants") and accompanying Series Warrants in a registered direct offering. The Series Warrants will be exercisable six months following the date of issuance. The Series A warrants will expire on the five one-half (5.5) year anniversary of the date of issuance. The short-term Series B warrants will expire on the two (2) year anniversary of the date of issuance. The closing of the offering is expected to occur on or about June 12, 2026, subject to the satisfaction of customary closing conditions.

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Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.5 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company. The potential additional gross proceeds to the Company from the Series Warrants, if fully exercised on a cash basis, will be approximately $12 million. No assurance can be given that any of the Series Warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the Series Warrants. The Company currently intends to use the net proceeds from the offering for clinical development of its product candidates, working capital and general corporate purposes.

The securities described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279367) that was filed with the Securities and Exchange Commission (the "SEC"), on May 13, 2024, and declared effective by the SEC on May 23, 2024. The securities offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus, when available, may also be obtained from Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Atossa Therapeutics, JUN 11, 2026, View Source [SID1234666581])

On June 11, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that two of its clinical-stage immunotherapy programs will be presented at the New York Academy of Sciences’ Frontiers in Cancer Immunotherapy symposium, being held June 22 – 23, 2026, at Memorial Sloan Kettering Cancer Center in New York City.

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The presentations will highlight Anixa’s ovarian cancer CAR-T therapy, liraltagene autoleucel, or lira-cel, which is being evaluated in an ongoing Phase 1 clinical trial, and Anixa’s breast cancer vaccine program, which completed a Phase 1 clinical trial in which all major primary endpoints were met and protocol-defined immune responses were generated in 74% of participants.

Frontiers in Cancer Immunotherapy brings together leading researchers, clinicians and industry innovators to explore next-generation therapies that are transforming cancer treatment. The symposium will showcase research and emerging approaches in areas including cancer vaccines, bispecifics, modulation of the tumor microenvironment, AI-driven discovery of immunotherapy and cell-based therapies for solid tumors. Additionally, Dr. Stephen Schoenberger, PhD, a world-renowned immunologist at the La Jolla Institute for Immunology and a member of Anixa’s Clinical Advisory Board, will be a featured speaker at the symposium.

"Presenting both of our clinical-stage immunotherapy programs at this symposium is an important opportunity to highlight the progress of our pipeline and the strength of the collaborations supporting these programs," said Dr. Amit Kumar, PhD, Chairman and CEO of Anixa Biosciences. "Our ovarian cancer CAR-T therapy and breast cancer vaccine program are being advanced with leading clinical and scientific institutions, and we believe these presentations underscore the potential of Anixa’s approach to treating and preventing cancer."

The Company’s lira-cel presentation, titled "A Phase I Clinical Trial of an Infusion of Autologous T cells Genetically Engineered with a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients with Recurrent Ovarian Cancer," will be given by Dr. Pamela D. Garzone, PhD, Chief Development Officer of Anixa Biosciences. The presentation will report the clinical trial design and objectives, as well as the current status of Anixa’s ongoing Phase 1 clinical trial of lira-cel.

The lira-cel presentation reflects contributions from investigators and collaborators across Anixa, Moffitt Cancer Center, Roswell Park Cancer Center, the University of Chicago School of Medicine and Duke University Medical Center. Project team members cited on the poster include:

Dr. Marco L. Davila, MD, PhD (Department of Medicine, Roswell Park Cancer Center)
Dr. Daniel Abate-Daga, PhD (Department of Immunology, Moffitt Cancer Center)
Dr. Melissa McGettigan, MD (Department of Radiology, Moffitt Cancer Center)
Dr. Xuefeng Wang, PhD (Department of Biostatistics and Bioinformatics, Moffitt Cancer Center)
Dr. Theresa Boyle, MD, PhD (Department of Pathology, Moffitt Cancer Center)
Dr. Amit Kumar, PhD (Anixa Biosciences, Inc.)
Denise Dorman, RN (Department of Gynecologic Oncology, Moffitt Cancer Center)
Dr. Richard Koya, MD, PhD (University of Chicago School of Medicine)
Dr. Christopher Cubitt, PhD (Immune Monitoring Core, Moffitt Cancer Center)
Dr. Jose Conejo-Garcia, MD, PhD (Department of Immunology, Duke University Medical Center)
Dr. Robert M. Wenham, MD, MS (Principal Investigator, Department of Gynecologic Oncology, Moffitt Cancer Center)
The Company’s breast cancer vaccine presentation, titled "Phase I Trial of an Alpha-Lactalbumin (aLA) Vaccine for Breast Cancer," will be given by Dr. Emily Esakov Rhoades, PhD, FDA/IND Trial Program Manager, Cleveland Clinic Cancer Institute. The presentation will report final Phase 1 findings for the investigational vaccine, including that all major primary endpoints were met, the vaccine was safe and well tolerated at the maximum tolerated dose based on safety and tolerability, and protocol-defined immune responses were elicited in 74% of trial participants. Immunohistochemistry of tumor samples demonstrating alpha-lactalbumin expression will also be reported.

The breast cancer vaccine presentation reflects contributions from Cleveland Clinic clinicians, translational researchers, patient advocates, and collaborators involved in advancing the program. The Cleveland Clinic team includes:

Dr. Justin M. Johnson, PhD (Department of Inflammation & Immunity, Cleveland Clinic)
Holly B. Levengood (Department of Inflammation & Immunity, Cleveland Clinic Cancer Institute)
Dr. Azka Ali, MD (Cleveland Clinic Cancer Institute)
Dr. Hannah Gilmore, MD (Robert J. Tomsich Pathology and Laboratory Medicine Institute)
Dr. Megan L. Kruse, MD (Cleveland Clinic Cancer Institute)
Dr. Erin E. Roesch, MD (Cleveland Clinic Cancer Institute)
Dr. Tiffany Onger, MD (Cleveland Clinic Cancer Institute)
Brenna Elliott (Cleveland Clinic Cancer Institute)
Elena Haury (Cleveland Clinic Cancer Institute)
Carolyn Porvasnik (Cleveland Clinic Cancer Institute)
Tobey Young (Previvorsandsurvivors.com, Inc.)
Terri Coutee (DiepCJourney Foundation)
Judith A. Fitzgerald, BCPA (Sisters4Prevention)
Dr. Thaddeus S. Stappenbeck, MD, PhD (Co-Principal Investigator, Chair – Department of Inflammation & Immunity, Cleveland Clinic)
Dr. G. Thomas Budd, MD (Principal Investigator, Cleveland Clinic Cancer Institute)
About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian and testis cells, tumor vasculature, and certain cancer cells, but not in other healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who are platinum resistant and have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, JUN 11, 2026, View Source [SID1234666580])

On June 12, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for an additional indication as maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer.

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"There is no established standard treatment for maintenance therapy following definitive chemoradiotherapy for locally advanced esophageal cancer. In the SKYSCRAPER-07 study, Tecentriq monotherapy indicated a trend toward improvement in overall survival and progression-free survival compared with placebo. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients as a new therapeutic option as soon as possible," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the global Phase III clinical study (SKYSCRAPER-07/ YO42137)1 in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study is a randomized, double-blind, multicenter trial comparing the efficacy and safety of maintenance therapy with Tecentriq in combination with tiragolumab (development discontinued) or Tecentriq monotherapy versus placebo. Based on the results from the first 2 and second interim analyses, it was confirmed that the Tecentriq monotherapy arm continued to show clinical benefit in the primary endpoint of overall survival (OS) and the secondary endpoint of investigator-assessed progression-free survival (PFS). The results of the second interim analysis are planned to be presented at an upcoming medical congress. The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

About the SKYSCRAPER-07 (YO42137) study1
SKYSCRAPER-07 is a global Phase III randomized, double-blind, multicenter study in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study evaluated the efficacy and safety of Tecentriq plus tiragolumab or Tecentriq monotherapy compared with placebo. Development of the Tecentriq plus tiragolumab combination was discontinued as no clinical benefit was observed in the primary PFS analysis and the first interim OS analysis (cutoff: February 18, 2025)2.

About maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer3
Esophageal cancer has an incidence rate in Japan (2021) of 34.7 per 100,000 population for men and 7.7 per 100,000 population for women. The number of deaths from esophageal cancer in 2024 was 10,638, and the 5-year relative survival rate (2009–2011) was 41.5%.
In Japan, squamous cell carcinoma is the most common histologic type. In unresectable, locally advanced esophageal squamous cell carcinoma, there is no clearly established standard treatment for patients without disease progression after definitive chemoradiotherapy, and new treatment options are needed.

About Tecentriq4
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JUN 11, 2026, View Source;category= [SID1234666579])

On June 11, 2026 Kyntra Bio (Nasdaq: KYNB) reported 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) (Free EHA Whitepaper) Congress 2026, taking place June 11-14, 2026 in Stockholm, Sweden.

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"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 (Free EHA Whitepaper) 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 (48% vs. 33%; p=0.22). The presentation highlights data from a post hoc analysis of the entire trial population, demonstrating that roxadustat led to similar rates of transfusion independence in both RS+ and RS- patients. In RS- patients, which comprised 84 of the 140 patients enrolled in the trial, treatment with roxadustat led to transfusion independence for ≥8 weeks over 28 weeks in 48% of patients vs. 28% for placebo.

The presentation at EHA (Free EHA Whitepaper) 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 77% are considered lower-risk MDS. Approximately 80% of patients with MDS have anemia at the time of diagnosis, and around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusion. Approximately 50% of patients with MDS require regular red blood cell transfusions. Transfusion dependent MDS patients suffer higher rates of cardiac events, infections, and iron overload with the related complications. In addition, anemia frequently leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Today, patients are routinely treated with erythropoiesis-stimulating agents (ESAs), luspatercept, imetelstat, or lenalidomide in lower-risk MDS with isolated del(5q), and hypomethylating agents (HMAs) in higher-risk disease. Only 35-40% of patients respond to current treatments and the durability of response is short. Moreover, these treatments are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. There remains a high unmet need for the treatment of anemia associated with MDS, and new strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with MDS.

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.

(Press release, Kyntra Bio, JUN 11, 2026, View Source [SID1234666578])