Y-Mabs Therapeutics Stock Price, News & Analysis

Y-mAbs Therapeutics (Nasdaq: YMAB) will release its Q1 2021 financial results on May 6, 2021, followed by a conference call on May 7, 2021, at 9 a.m. ET. The call will include updates from key executives: Chairman Thomas Gad, CEO Dr. Claus Moller, and CFO Bo Kruse. Y-mAbs focuses on developing antibody-based cancer therapies, with one FDA approved product, DANYELZA®, and another candidate, omburtamab, in pivotal stages. Forward-looking statements are included, highlighting potential risks in clinical trials and market acceptance.

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has announced the acceptance of two poster presentations for DANYELZA and an oral presentation for omburtamab at the American Society of Clinical Oncology Virtual Annual Meeting from June 4-8, 2021. Key topics include the efficacy of naxitamab in high-risk neuroblastoma and a Phase 1 trial of omburtamab for diffuse intrinsic pontine glioma. The collaborations involve researchers from Memorial Sloan Kettering Cancer Center and SJD Barcelona Children's Hospital. Y-mAbs focuses on antibody-based cancer therapeutics, with a pipeline including DANYELZA, which is FDA-approved.

Y-mAbs Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for omburtamab, a monoclonal antibody targeting B7-H3, aimed at treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. This submission could position omburtamab as the first EMA-approved targeted therapy for this condition. Additionally, Y-mAbs plans to resubmit its Biologics License Application (BLA) to the FDA in late Q2 or early Q3 2021, highlighting its commitment to addressing a significant unmet medical need in pediatric oncology.

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced a regulatory update for its investigational monoclonal antibody omburtamab, which targets B7-H3 for treating pediatric CNS metastasis from neuroblastoma. Following a Type B meeting with the FDA, additional data requests were made regarding historical control groups. Y-mAbs aims to resubmit its Biologics License Application (BLA) by mid-2021, with further discussions scheduled for June 1. The company is also targeting a Marketing Authorization Application submission to the European Medicines Agency by April 30, 2021.

Y-mAbs Therapeutics, a biopharmaceutical company, recently presented its SADA technology platform at the AACR Annual Meeting on April 10, 2021. This platform aims to improve radioimmunotherapy for colorectal peritoneal carcinomatosis. The GPA33-SADA construct demonstrated a favorable tumor-to-blood radioactivity ratio of 122. Y-mAbs plans to submit its first IND for this construct in 2022, having licensed the technology from MSK and MIT. The company is focused on developing antibody-based cancer treatments, including the FDA-approved DANYELZA.

Y-mAbs Therapeutics reported a net loss of $119.3 million for 2020, a significant increase from $81.0 million in 2019. The company earned $20.8 million from licensing agreements, a considerable rise from no revenues reported in the previous year. R&D expenses soared to $93.7 million, up from $63.5 million, due to increased personnel and milestone costs. General administrative expenses also rose to $44.8 million. Notably, Y-mAbs sold a Priority Review Voucher for $105 million and completed a follow-on offering generating $115 million. The company is progressing with its clinical programs and collaborations.

Y-mAbs Therapeutics announced the successful closing of a public offering of 2,804,878 shares at $41.00 per share, raising approximately $115 million in gross proceeds. This offering included the full exercise of underwriters' option for 365,853 additional shares. The shares were offered under a shelf registration statement filed with the SEC and are listed on Nasdaq under the ticker symbol YMAB. Leading investment banks J.P. Morgan, Morgan Stanley, and BofA Securities managed the offering.

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) will announce its financial results for the fiscal year ended December 31, 2020, on February 25, 2021, after U.S. market close. A conference call and webcast will follow on February 26, 2021, at 9 a.m. ET, featuring company executives. Y-mAbs is focused on developing antibody-based cancer therapies, boasting one FDA-approved product, DANYELZA® (naxitamab-gqgk), and a pivotal-stage candidate, omburtamab. The press release includes forward-looking statements on business strategies and financial expectations, emphasizing the need for future funding.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced a public offering of 2,439,025 shares at $41.00 each, expected to generate approximately $100 million in gross proceeds. All shares are offered by Y-mAbs, with an additional 365,853 shares available for underwriters to purchase within 30 days. The offering is set to close on February 22, 2021, pending customary conditions. J.P. Morgan, Morgan Stanley, and BofA Securities are the joint book-running managers. Proceeds will support Y-mAbs' advanced product pipeline for cancer therapies, including FDA-approved DANYELZA® and pivotal-stage omburtamab.