Y-mAbs Therapeutics announces data for omburtamab » 09:0310/0310/03/22
Y-mAbs Therapeutics announced clinical data on the Company's product candidate OMBLASTYS for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. Data was presented by Dr. Kim Kramer from Memorial Sloan Kettering, MSK, Cancer Center at the International Society of Pediatric Oncology Annual Congress held September 28 through October 1, 2022, in Barcelona, Spain. In an oral presentation, Dr. Kramer presented interim results for 32 patients enrolled in the Company's ongoing pivotal 101 multicenter study of omburtamab radiolabeled with Iodine-131. The results showed a twelve-month overall survival of 73.5%, with a median follow-up of 25 months. Further, the interim results showed an objective response rate of 31.3% in the patients with measurable disease after central review based on Response Assessment in Neuro-Oncology criteria and European Association of Neuro-Oncology/European Society for Medical Oncology criteria, and that a total of 75.0% of the patient with measurable disease achieved disease control. Serious Adverse Events was found in 40.6% of the patients and were mostly related to myelosuppression. "We are excited to report these data that together with Study 03-133 is the basis of our BLA," said Thomas Gad, President, and Interim Chief Executive Officer. "The disease burden these patient and their families are facing represent a significant unmet medical need, which we hope to be able to address with OMBLASTYS after our PDUFA date on November 30, 2022."
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Y-mAbs Therapeutics announces regulatory filing for DANYELZA in Brazil » 09:1009/2609/26/22
Y-mAbs Therapeutics announced that Adium Pharma has submitted a regulatory filing for DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the Brazilian Health Regulatory Agency, Agencia Nacional de Vigilancia Sanitaria.
|Over a month ago|
Y-mAbs, Takeda announce marketing authorization in Israel for DANYELZA » 09:0608/3008/30/22
Y-mAbs Therapeutics (YMAB) and Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TAK) announced that the Israeli Ministry of Health has approved DANYELZA in Israel for the treatment, in combination with granulocyte-macrophage colony-stimulating factor, of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. In Israel, DANYELZA is expected to be commercialized by Takeda Israel, under the exclusive license and distribution agreement entered in 2020 between Takeda Israel and the Company.
Y-mAbs Therapeutics reports Q2 EPS (94c) vs. (53c) last year » 16:4908/0808/08/22
Reports Q2 revenue…
Reports Q2 revenue $10.8M, consensus $11.22M ."The highlight of the second quarter was FDA acceptance of our BLA filing for omburtamab," said Thomas Gad, President, and Interim Chief Executive Officer. "We are excited about the upcoming PDUFA date, which we believe brings us closer to the potential approval and achieving our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors. We were also thrilled to announce that the Phase 2 naxitamab chemo-immunotherapy trial met primary endpoints achieving an impressive response rate further underscoring DANYELZA potential in high-risk neuroblastoma. Our strong balance sheet with $133.7 million in cash is expected to support us through multiple potentially value-creating catalysts and into mid-2024."
Y-mAbs Therapeutics announces clearance of IND for GD2-SADA » 09:0307/1207/12/22
Y-mAbs Therapeutics announced initiation of its first clinical trial with a SADA construct. This Phase 1 multicenter basket trial targets malignant melanoma, sarcoma and small cell lung cancer. The trial will have three parts: Part A with dose-finding for the SADA molecule and testing of dosing intervals between the protein and the 177Lu-DOTA payload, Part B will determine the optimal dose of 177Lu-DOTA, and Part C will be evaluating safety and initial signals of efficacy using repeated dosing. The Company expects a total of approximately 59 patients at 6-10 U.S. sites to be included in the trial. "The FDA acceptance of the IND for GD2-SADA marks an important milestone towards our mission of developing novel SADA treatments as we continue to execute our clinical development strategy for our pipeline of SADA constructs for the treatment of cancers with unmet medical need," said Thomas Gad, founder, President and Interim CEO. "We are seeing significant partnership interest for the SADA technology and we believe we are well-positioned to leverage the SADA platform as we move forward. We are truly excited about the potential of the SADA technology, which has already shown great promise, and we believe that it can further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents."
Y-mAbs Therapeutics assumed with a Buy at Canaccord » 07:4307/0607/06/22
Canaccord analyst William…
Canaccord analyst William Maughan assujmed coverage of Y-mAbs Therapeutics with a Buy rating and $35 price target. Y-mAbs is "lean" for a commercial biotech, with a focus on rare pediatric indications, Maughan tells investors in a research note. He says the company is in a good position to reach cashflow positive with little additional financing.
|Over a quarter ago|
Y-mAbs Therapeutics initiated with an Outperform at BMO Capital » 16:0606/2306/23/22
BMO Capital analyst Etzer…
BMO Capital analyst Etzer Darout initiated coverage of Y-mAbs Therapeutics with an Outperform rating and $27 price target. The stock offers an "underappreciated story" given the potential for an omburtamab approval by year-end, several label expansion opportunities, and a novel technology in early Phase of development that could meaningfully improve how patients are treated with radiopharmaceutical drugs, the analyst tells investors in a research note. Darout ascribes $12 to omburtamab in LM/CNS and risk-adjusted opportunities in diffuse intrinsic pontine glioma and desmoplastic small round cell tumors.
Y-mAbs Therapeutics announces FDA acceptance of BLA for OMBLASTYS » 09:1405/3105/31/22
Y-mAbs Therapeutics announced that the Biologics License Application, BLA, for OMBLASTYS for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration, FDA. The FDA set an action date of November 30, 2022, under the Prescription Drug User Fee Act, PDUFA. The Agency also indicated in the BLA filing communication letter that it is planning to hold an advisory committee meeting in October 2022 to discuss the application. "We believe that the FDA's acceptance of our OMBLASTYS BLA for priority review is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that OMBLASTYS, if approved by the FDA, can address a significant unmet medical need for children with CNS/leptomeningeal metastasis from high-risk neuroblastoma, where no standard therapy currently exists, potentially adding a second rare disease product to our commercial portfolio and without any significant further investment in our existing commercial infrastructure. Further, OMBLASTYS has a Rare Pediatric Disease Designation which, if approved, will provide Y-mAbs with a Priority Review Voucher, our second PRV, which would further strengthen our financial position as we would seek to monetize the OMBLASTYS PRV," stated Thomas Gad, Founder, President and Interim CEO. "We look forward to working with the Agency to bring OMBLASTYS to the appropriate patients. We are excited to move forward and plan for a seamless commercial launch of OMBLASTYS, if approved by the FDA."
Y-mAbs trial for high-risk neuroblastoma meets primary endpoint » 16:1005/2605/26/22
Y-mAbs Therapeutics announced that Dr. Shakeel Modak, MD from Memorial Sloan Kettering will present results from the naxitamab-based chemoimmunotherapy trial in patients with chemoresistant high-risk neuroblastoma , at the American Society of Clinical Oncology Annual Meeting to be held June 3-7, 2022. This clinical trial studied the combination of Humanized anti-GD2 antibody naxitamab, Irinotecan, Temozolomide and Sargramostim protocol, and included cohort of patients that were treated at MSK in a phase 2 protocol, and at Hospital Sant Joan de Deu per protocol on compassionate use basis. Health authorities have not established the safety and efficacy of the HITS protocol, as it is investigational and has not been approved by health authorities. The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate according to the International Neuroblastoma Response Criteria of 30.6 %, with a lower boundary of 20.4%. In the entire cohort, responses were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable disease and 27% for progressing disease . In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue and skeletal MIBG uptake. CR in bone marrow was seen in 57% of the patients. The ORR in patients with MYCN-amplification was 25%, in patients with refractory disease 100%, and in patients with relapsed disease 61%. Moreover, in patients who had previously received irinotecan/temozolomide or naxitamab, the ORR was 64% and 68%, respectively. In patients who had previously received dinutuximab/irinotecan/temozolomide, the ORR was 42%. The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate according to the International Neuroblastoma Response Criteria of 30.6 %, with a lower boundary of 20.4%. In the entire cohort, responses were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable disease and 27% for progressing disease . In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue (48%) and skeletal MIBG uptake . CR in bone marrow was seen in 57% of the patients. The ORR in patients with MYCN-amplification was 25%, in patients with refractory disease 100%, and in patients with relapsed disease 61%. Moreover, in patients who had previously received irinotecan/temozolomide or naxitamab, the ORR was 64% and 68%, respectively. In patients who had previously received dinutuximab/irinotecan/temozolomide, the ORR was 42%. "We are very pleased to present data for the HITS protocol," stated Thomas Gad, Founder, President and Interim CEO. "Responses in patients with relapsed or progressive high-risk neuroblastoma are challenging, as chemo-resistant disease is considered an obstacle, so we are excited to see this study met its primary endpoint. This further demonstrates the potential role for DANYELZA in HR-NB. No other GD2 antibody has been studied in such a heavily pre-treated patient population."
Y-mAbs Therapeutics reports Q1 EPS (64c), consensus (72c) » 16:0905/0905/09/22
Reports Q1 revenue…
Reports Q1 revenue $10.5M, consensus $10.9M. "Y-mAbs had a successful first quarter. We resubmitted the omburtamab BLA, bringing us one step closer to the potential approval and achieving our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors," said Thomas Gad, Interim Chief Executive Officer. "We are very encouraged by our first quarter financial results, driven by our continued execution of the DANYELZA launch which generated revenues of $10.5 million. Based on the steady progress and a strong first quarter we anticipate full-year 2022 DANYELZA revenues in the range of $45-50 million. Our strong balance sheet with $156.7 million in cash, and anticipated revenues from product sales, is expected to support us through multiple potentially value-creating catalysts and into mid-2024."