This section highlights FDA-related milestones and regulatory updates for drugs developed by Y-mAbs Therapeutics (YMAB).
Over the past two years, Y-mAbs Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CD38-SADA, DANYELZA, GD2-SADA, and naxitamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CD38-SADA FDA Regulatory Timeline and Events
CD38-SADA is a drug developed by Y-mAbs Therapeutics for the following indication: Relapsed or Refractory non-Hodgkin Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CD38-SADA
- Announced Date:
- April 27, 2025
- Indication:
- Relapsed or Refractory non-Hodgkin Lymphoma.
Announcement
Y-mAbs Therapeutics, Inc. announced the presentation of preclinical and translational pharmacokinetics (PK) data of CD38-SADA in a poster at the 2025 American Association of Cancer Research (AACR) Annual Meeting being held on April 25-30, 2025 in Chicago, IL.
AI Summary
Y-mAbs Therapeutics, Inc. announced that they will present preclinical and translational pharmacokinetics (PK) data of their novel CD38-SADA protein at the upcoming 2025 American Association of Cancer Research (AACR) Annual Meeting in Chicago, Illinois, from April 25-30, 2025. The poster, titled “Preclinical and translational pharmacokinetic (PK) modeling of the self-assembling and disassembling (SADA) bispecific fusion protein CD38-SADA for first-in-human (FIH) pretargeted radioimmunotherapy (PRIT),” details how CD38-SADA behaves in animal models. The study used various PK data and in vitro binding kinetics to show that while the CD38-SADA tetramers efficiently target tumors, the smaller CD38-SADA monomers clear from the bloodstream up to 20 times faster. These insights are key in optimizing dosing regimens for the upcoming first-in-human Phase 1 trial in patients with relapsed or refractory NHL.
Read Announcement- Drug:
- CD38-SADA
- Announced Date:
- April 25, 2025
- Indication:
- Relapsed or Refractory non-Hodgkin Lymphoma.
Announcement
Y-mAbs Therapeutics, Inc. announced that the first patient has been administered both the first protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial evaluating the Company's Self-Assembly and Disassembly ("SADA") Pre-targeted Radioimmunotherapy ("PRIT") platform for the treatment of patients with relapsed or refractory non-Hodgkin Lymphoma (r/r NHL).
AI Summary
Y-mAbs Therapeutics, Inc. recently announced an important milestone in its clinical research. The company has begun dosing in its Phase 1 clinical trial for patients with relapsed or refractory non-Hodgkin Lymphoma using its Self-Assembly and Disassembly (SADA) Pre-targeted Radioimmunotherapy (PRIT) platform. In this trial—known as Trial 1201—the first patient received both the initial protein dose and a 177Lu-DOTA imaging dose.
This two-step treatment involves first administering a CD38-SADA protein that binds to lymphoma cells. Once the protein has attached to the tumor, a radioactive 177Lu-DOTA dose is given, aiming to deliver targeted radiation while reducing exposure to healthy tissues. The trial focuses on understanding the safety, optimal protein dose, and timing between the protein and radioactive doses, which may offer new hope for patients with limited treatment options.
Read Announcement- Drug:
- CD38-SADA
- Announced Date:
- December 7, 2024
- Indication:
- Relapsed or Refractory non-Hodgkin Lymphoma.
Announcement
Y-mAbs Therapeutics, Inc. announced the presentation of CD38-SADA in Non-Hodgkin Lymphoma (NHL) preclinical data and trial in progress posters at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition being held on December 7 –10, 2024, in San Diego, California.
AI Summary
Y-mAbs Therapeutics, Inc. announced that it will present cutting-edge posters on its CD38-SADA technology at the 66th American Society of Hematology Annual Meeting & Exposition in San Diego from December 7–10, 2024. One poster details preclinical data demonstrating that CD38-SADA, a novel bispecific fusion protein, shows rapid and dose-dependent anti-tumor activity in Non-Hodgkin Lymphoma models when combined with Lutetium 177 (Lu177)-DOTA. The data highlight the protein’s ability to selectively bind to CD38-positive tumor cells, setting the stage for a two-step pretargeted radioimmunotherapy approach.
The second poster provides an update on the ongoing Phase 1 Trial 1201, which is evaluating the safety and tolerability of CD38-SADA PRIT in patients with relapsed or refractory NHL. The trial uses a dose-escalation design to determine optimal dosing for both the fusion protein and the radioactive payload, indicating promising potential for improved treatment outcomes in NHL patients.
Read Announcement
DANYELZA (naxitamab-gqgk) FDA Regulatory Events
DANYELZA (naxitamab-gqgk) is a drug developed by Y-mAbs Therapeutics for the following indication: Relapsed/refractory high-risk Neuroblastoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DANYELZA (naxitamab-gqgk)
- Announced Date:
- May 7, 2025
- Indication:
- Relapsed/refractory high-risk Neuroblastoma
Announcement
Y-mAbs Therapeutics, Inc. announced that naxitamab-gqgk (DANYELZA®) is recommended by the National Comprehensive Cancer Network® ("NCCN") Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a NCCN Category 2A treatment option for high-risk neuroblastoma.
AI Summary
Y-mAbs Therapeutics, Inc. announced that its treatment, naxitamab-gqgk (DANYELZA®), is now recommended in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a Category 2A treatment option for high-risk neuroblastoma. This update means that the NCCN supports DANYELZA as a strong treatment choice for patients with this aggressive form of cancer. According to company representatives, the guideline recommendation reinforces the value of DANYELZA as a leading anti-GD2 therapy for patients with relapsed or refractory high-risk neuroblastoma. The decision suggests that the therapy is considered a reliable, evidence-based option by experts involved in cancer care. The update is significant as it helps inform physicians and families about effective treatment strategies for managing and potentially improving outcomes in high-risk neuroblastoma cases.
Read Announcement- Drug:
- DANYELZA (naxitamab-gqgk)
- Announced Date:
- March 4, 2025
- Indication:
- Relapsed/refractory high-risk Neuroblastoma
Announcement
Y-mAbs Therapeutics, Inc. provided Recent Corporate Developments
AI Summary
On January 10, 2025, Y-mAbs Therapeutics announced a major internal realignment by creating two business units – one focused on DANYELZA and the other on Radiopharmaceuticals. This change is aimed at optimizing internal resources and enhancing flexibility while advancing their novel SADA PRIT programs through clinical development. The realignment is expected to drive future growth for DANYELZA and accelerate the progress of radioimmunotherapy programs. Along with this restructuring, the company appointed Doug Gentilcore as Senior Vice President and Head of the DANYELZA Business Unit, bringing over 20 years of industry experience. These steps are part of the company’s strategic plan to improve operational efficiency and capitalize on its innovative technologies in cancer treatment, ensuring greater agility as they move forward in clinical and commercial developments.
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GD2-SADA FDA Regulatory Timeline and Events
GD2-SADA is a drug developed by Y-mAbs Therapeutics for the following indication: Positive Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GD2-SADA
- Announced Date:
- May 26, 2025
- Indication:
- Positive Solid Tumors
Announcement
Y-mAbs Therapeutics, Inc. announced the presentation of GD2-SADA in recurrent or refractory metastatic solid tumors known to express GD2 in a trial in progress poster at the Advances in Neuroblastoma Research Meeting ("ANR") being held on May 25-28, 2025 in Washington, D.C.
AI Summary
Y-mAbs Therapeutics, Inc. presented data on its innovative GD2-SADA treatment at the Advances in Neuroblastoma Research Meeting held in Washington, D.C. from May 25-28, 2025. The treatment is being evaluated in a Phase 1 clinical trial (Trial 1001, NCT05130255) that targets recurrent or refractory metastatic solid tumors expressing the GD2 antigen, including high‐risk neuroblastoma. This trial uses a pretargeted radioimmunotherapy approach. First, GD2-SADA is infused to bind to GD2-positive tumors, and unbound protein is cleared from the body. Then, a second infusion of Lutetium 177 DOTA (177Lu-DOTA) delivers targeted radiation. The trial focuses on determining the optimal safe dosage of the GD2-SADA protein and the best timing for the two-step infusion process. Early results from Part A have been promising, with a detailed data update expected during a virtual event on May 28, 2025.
Read Announcement- Drug:
- GD2-SADA
- Announced Date:
- January 31, 2025
- Indication:
- Positive Solid Tumors
Announcement
Y-mAbs Therapeutics, Inc announced the presentation of preclinical and translational pharmacokinetics (PK) data of GD2-SADA in a poster at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Mid-Winter and American College of Nuclear Medicine (ACNM) Annual Meeting being held on January 30 to February 1, 2025 in Anaheim, California.
AI Summary
Y-mAbs Therapeutics, Inc. recently announced that it will present new preclinical and translational pharmacokinetics (PK) data of its GD2-SADA candidate at the upcoming SNMMI Mid-Winter and ACNM Annual Meeting in Anaheim, California, from January 30 to February 1, 2025. The data, shown in a poster titled “Preclinical and Translational Pharmacokinetics of GD2-SADA, a Self-Assembling and Disassembling (SADA) Bispecific Fusion Protein for Pretargeted Radioimmunotherapy (PRIT),” explores how GD2-SADA behaves over time in animal models. It examines the plasma levels across different doses and the equilibrium between its tetramer and monomer forms in vitro. These PK insights are valuable for understanding tumor exposure and plasma elimination, helping to refine dosing strategies for reducing systemic exposure to 177Lutetium-DOTA in ongoing clinical trials.
Read Announcement- Drug:
- GD2-SADA
- Announced Date:
- June 7, 2024
- Indication:
- Positive Solid Tumors
Announcement
Y-mAbs Therapeutics, Inc announced that preclinical GD2-SADA data will be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8 – 11, 2024, in Toronto, Canada.
AI Summary
Y-mAbs Therapeutics, Inc. announced that it will present its preclinical GD2-SADA data at the SNMMI 2024 Annual Meeting, scheduled for June 8–11 in Toronto, Canada. The data will be shared through a poster presentation (#241436) that focuses on "High-affinity and specific binding between DOTA-chelated lanthanides and GD2-SADA."
The research highlights how GD2-SADA, a self-assembling and disassembling bispecific fusion protein, binds with high affinity to DOTA-chelated lanthanides. This two-step pre-targeted radioimmunotherapy (PRIT) approach could improve the delivery of diagnostic and therapeutic radionuclides directly to GD2-expressing tumors. The preclinical findings support the future clinical development of GD2-SADA, reinforcing its potential role in enhancing both tumor diagnosis and treatment in cancer patients.
Read Announcement- Drug:
- GD2-SADA
- Announced Date:
- June 1, 2024
- Indication:
- Positive Solid Tumors
Announcement
Y-mAbs Therapeutics, Inc announced the publication of preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology ("ASCO") Annual Meeting, taking place May 31 through June 4, 2024, in Chicago, IL.
AI Summary
Y-mAbs Therapeutics, Inc. announced that its preclinical GD2-SADA data will be presented at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago, IL, scheduled for May 31 through June 4, 2024. The study focuses on GD2-SADA, a protein that self-assembles and disassembles, making it useful for targeted radioimmunotherapy. Researchers found that GD2-SADA binds tightly to several GD2-positive cancer cell lines and to lanthanide metal-DOTA complexes, which play a critical role in delivering the radioactive treatment. The data show that when GD2-SADA is used with Lutetium 177-DOTA in a two-step approach, it provides strong anti-tumor effects. These findings support further development of their SADA Pretargeted Radioimmunotherapy (PRIT) technology and underline its potential in improving treatment for patients with GD2-positive tumors.
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Naxitamab FDA Regulatory Timeline and Events
Naxitamab is a drug developed by Y-mAbs Therapeutics for the following indication: For the treatment of cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- naxitamab
- Announced Date:
- March 3, 2025
- Indication:
- For the treatment of cancer
Announcement
Y-mAbs Therapeutics, Inc announced the publication of interim data from a Phase 2 clinical trial evaluating naxitamab with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with relapsed/refractory high-risk neuroblastoma in the journal Nature Communications..
AI Summary
Y-mAbs Therapeutics, Inc. recently announced the publication of interim data from a Phase 2 clinical trial in the journal Nature Communications. The trial evaluated naxitamab combined with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with relapsed or refractory high-risk neuroblastoma that had residual disease in the bone and bone marrow. Patients received naxitamab on days 1, 3, and 5 with GM-CSF administered from days -4 to 5, repeated every four weeks until a complete or partial response was achieved.
The interim results were promising, with an overall response rate of 50%, including 38% achieving a complete response and 12% a partial response. The study also reported a significant response in bone and bone marrow compartments. These findings suggest that naxitamab, with its manageable safety profile, could be a valuable treatment option for patients facing this difficult-to-treat cancer.
Read Announcement- Drug:
- naxitamab
- Announced Date:
- September 6, 2024
- Indication:
- For the treatment of cancer
Announcement
Y-mAbs Therapeutics, Inc announced new clinical and preclinical data from studies evaluating naxitamab and GD2-SADA, respectively, in neuroblastoma.
AI Summary
Y-mAbs Therapeutics, Inc. announced new clinical and preclinical data for two neuroblastoma treatments. In a clinical study, naxitamab was given to patients with refractory or relapsed high-risk neuroblastoma. Results from this study showed that when used with GM-CSF, naxitamab achieved a 63% disease control rate over a minimum of 12 weeks. This indicates that the drug maintains disease control in a challenging patient group. In a separate preclinical study, researchers evaluated GD2-SADA, a bispecific fusion protein designed for targeted radiotherapy. The study demonstrated that GD2-SADA forms tetramers that tightly bind to a chelated radioisotope, Tb-DOTA, providing a focused radiation dose to tumor cells while minimizing off-target effects. These promising findings support the ongoing clinical development of GD2-SADA in upcoming trials for neuroblastoma and other GD2-positive tumors.
Read Announcement- Drug:
- naxitamab
- Announced Date:
- June 1, 2024
- Indication:
- For the treatment of cancer
Announcement
Y-mAbs Therapeutics, Inc announced new interim data from the Phase 2 Trial 201 of naxitamab in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF") in patients with relapsed or refractory high-risk neuroblastoma with residual disease limited to bone and/or bone marrow. .
AI Summary
Y-mAbs Therapeutics, Inc. recently announced interim data from Phase 2 Trial 201 that evaluates naxitamab combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). This study focused on patients with relapsed or refractory high‐risk neuroblastoma who still have residual disease confined to bone and/or bone marrow after previous treatments. Researchers are investigating whether adding GM-CSF can boost the effects of naxitamab, an anti‐GD2 antibody therapy, to better target tumor cells that have persisted in these sites.
The interim results from this trial provide early evidence supporting the potential clinical benefit of this combination treatment. The data are a significant step in understanding how tailored immunotherapy regimens like naxitamab plus GM-CSF may improve outcomes in high‐risk neuroblastoma, offering new hope for patients with limited treatment options. Further studies will help confirm these findings and may lead to enhanced treatment strategies for this challenging pediatric cancer.
Read Announcement
