Y-mAbs Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on the development and commercialization of antibody based therapeutic products for the treatment of cancer. Its services include discovery, protein engineering, clinical and regulatory. Y-mAbs Therapeutics was founded by Thomas Gad in April 2015 and is headquartered in New York, NY.
相关临床试验
17
3 进行中
药物批准
3
批准总数
监管机构
2
监管机构数
成立时间
2015
进行中（未招募）
3
17.6%
已完成
1
5.9%
终止
10
58.8%
撤回
3
17.6%
- Y-mAbs Therapeutics faced a major setback when the FDA rejected its biologics license application for omburtamab, an antibody therapy for pediatric neuroblastoma patients with central nervous system metastasis, in late 2022. - The company has restructured its pipeline priorities and cost base following the rejection, focusing on disciplined R&D investment and reducing cash burn while exploring strategic alternatives for omburtamab. - Y-mAbs continues to advance other antibody-based therapies including naxitamab for relapsed or refractory high-risk neuroblastoma, while maintaining its focus on pediatric oncology through academic partnerships. - The company operates in the high-risk pediatric oncology niche with potential for significant commercial impact if regulatory approval is achieved, though the omburtamab rejection highlights substantial regulatory risks for small-cap biotech investors.
- SERB Pharmaceuticals announced an all-cash acquisition of Y-mAbs Therapeutics for $8.60 per share, representing a 105% premium and $412 million equity value. - The acquisition includes DANYELZA (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in pediatric and adult patients. - DANYELZA expands SERB's rare oncology portfolio and provides outpatient treatment options for neuroblastoma patients who have shown partial response, minor response, or stable disease to prior therapy. - The transaction is expected to close by Q4 2025, with SERB leveraging its global footprint to expand DANYELZA's reach to new markets.
- The osteosarcoma market in the 7MM is expected to grow significantly by 2034, driven by extensive R&D activities and the entry of novel therapies including OST-HER2, Naxitamab 15-096, and HALMB-0168. - OS Therapies plans to submit a Biologics License Application for OST-HER2 to the US FDA by 2025, with the potential to receive a Priority Review Voucher upon approval. - The market faces challenges including chemotherapy resistance in approximately half of patients and limited treatment options for relapsed or refractory cases. - Currently, MEPACT (mifamurtide) remains the only approved therapy specifically for osteosarcoma, highlighting significant unmet medical needs in this rare cancer.
- Y-mAbs Therapeutics presented preclinical pharmacokinetics data for CD38-SADA at the 2025 AACR Annual Meeting, demonstrating key insights into the protein's behavior in animal models. - The study revealed that CD38-SADA monomers clear from plasma 20 times faster than tetramers, supporting the pretargeted radioimmunotherapy approach for improved tumor-to-normal tissue dose ratios. - These preclinical findings informed the design and dosing regimen for the ongoing first-in-human Phase 1 Trial 1201 in patients with relapsed/refractory non-Hodgkin lymphoma. - The company has already dosed the first patient in Trial 1201, marking a significant milestone for the CD38-SADA pretargeted radioimmunotherapy platform.
- Y-mAbs Therapeutics has dosed the first patient in its Phase 1 trial of CD38-SADA PRIT platform for relapsed/refractory non-Hodgkin Lymphoma, marking its first clinical program in hematological malignancies. - The innovative two-step approach delivers CD38-SADA protein that binds to lymphoma cells, followed by a radioactive 177Lu-DOTA payload that targets tumor-bound molecules while minimizing radiation exposure to healthy tissues. - This trial (1201) is designed as a dose-escalation, open-label study to determine optimal protein dosing and administration intervals, potentially offering new treatment options for NHL patients with limited alternatives.
- Phase 2 trial of naxitamab with GM-CSF achieved 50% overall response rate in patients with relapsed/refractory high-risk neuroblastoma, meeting its primary endpoint. - The treatment demonstrated strong efficacy with 58% bone compartment response and 74% bone marrow compartment response, showing particular promise for patients with bone involvement. - Notable one-year survival outcomes include 93% overall survival rate, while some patients previously treated with anti-GD2 antibodies showed response to naxitamab therapy.
- Y-mAbs is reorganizing into two business units focusing on radiopharmaceuticals and DANYELZA to enhance clinical development and commercial growth. - Preliminary Phase 1 data for GD2-SADA demonstrates tolerability and validity of the SADA PRIT pre-targeting approach in solid tumors. - The company anticipates presenting GD2-SADA Phase 1 data in Q2 2025 and dosing the first patient in the CD38-SADA Phase 1 trial in Q1 2025. - Y-mAbs reports estimated 2024 total net revenue of $88 million and anticipates cash to support operations into 2027.
- Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. - Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. - These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. - The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
