Y-mAbs Therapeutics, Inc. - YMAB STOCK NEWS

Y-mAbs Therapeutics (YYMB) announced significant clinical updates on its therapies naxitamab and omburtamab at the SIOP Virtual Annual Congress. Naxitamab demonstrated a 68% overall response rate, with 59% achieving complete responses in a pivotal study of 22 patients. Meanwhile, omburtamab showed a promising 87% overall survival rate at 12 months in a study of 17 patients, compared to 30% in a historical control. The FDA has set a PDUFA date for naxitamab on November 30, 2020, indicating potential market entry for these novel cancer treatments.

Y-mAbs Therapeutics has received FDA clearance for its Investigational New Drug application for ¹⁷⁷Lu-omburtamab-DTPA, aimed at treating medulloblastoma, a common childhood brain cancer. This product utilizes a radiolabeled antibody and is scheduled for a Phase 1/2 clinical trial targeting pediatric patients later in 2020. The company plans to also initiate a separate trial for adults with B7-H3 positive CNS/LM cancers. The omburtamab antibody was developed by Memorial Sloan Kettering, which has financial interests in Y-mAbs.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced the FDA's grant of Orphan Drug Designation and Rare Pediatric Disease Designation for its bispecific antibody nivatrotamab, aimed at treating neuroblastoma. This designation provides potential market exclusivity of seven years post-approval and eligibility for a Priority Review Voucher. Currently in Phase 1 trials, nivatrotamab is developed in collaboration with Memorial Sloan Kettering Cancer Center and will expand into Phase 2 studies for neuroblastoma and osteosarcoma, as well as a new study in small cell lung cancer expected to begin in Q4 2020.

Y-mAbs Therapeutics announced it received a Refusal to File letter from the FDA for its Biologics License Application (BLA) of omburtamab, aimed at treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The FDA cited the need for additional details in the Chemistry, Manufacturing and Control module and the Clinical module of the BLA. Y-mAbs plans to address these concerns and resubmit the BLA by year-end 2020, following a Type A meeting with the FDA. An investor call is set for October 6, 2020, to discuss this update.

Y-mAbs Therapeutics reported its second quarter 2020 financial results, highlighting a net loss of $40.4 million, or $1.01 per share, compared to a loss of $18.0 million in Q2 2019. The company completed its omburtamab BLA submission and received FDA priority review for naxitamab. R&D expenses surged to $30.1 million due to increased milestones and personnel costs. General and administrative costs also rose to $10.4 million. As of June 30, 2020, Y-mAbs had $158.1 million in cash, down from $207.1 million at year-end 2019.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced the submission of its Biologics License Application for omburtamab on August 5, 2020. This investigational monoclonal antibody targets B7-H3 to treat pediatric CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on pivotal Phase 2 study results. The company aims to address an unmet medical need as no standard therapies are available for these patients. Y-mAbs has additional studies planned for omburtamab in other cancer types.

Y-mAbs Therapeutics (YMAB) announced acceptance of five oral presentations for its lead product naxitamab at the SIOP Virtual Annual Congress, scheduled for October 14-17, 2020. Naxitamab is under priority review by the FDA for relapsed/refractory high-risk neuroblastoma, with an action date of November 30, 2020. The company also reported on omburtamab and its GD2-GD3 vaccine candidates, indicating progress in clinical trials. Y-mAbs continues to focus on developing antibody-based therapies for pediatric cancers.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced that Dr. Brian H. Santich will present an update on the SADA technology at the SNMMI Virtual Annual Meeting on July 14, 2020. SADA technology demonstrates effective 2-step payload delivery, showcasing tumor shrinkage without harming other tissues. Four targets are in pre-clinical development, including B7-H3 SADA for prostate cancer. The company plans to submit its first IND for a SADA construct in 2021, aiming to innovate cancer treatment with Liquid Radiation™.

Y-mAbs Therapeutics (YMAB) announced the initiation of its Biologics License Application for omburtamab under the FDA's Rolling Review process. This investigational monoclonal antibody targets B7-H3 in pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. The non-clinical and part of the CMC portions of the BLA were submitted in June 2020, with completion expected in 4-6 weeks. Clinical submission will rely on pivotal Phase 2 studies 101 and 03-133. Omburtamab aims to address significant unmet medical needs for affected children, representing a key milestone for Y-mAbs.