Y-Mabs Therapeutics Stock Price, News & Analysis

Y-mAbs Therapeutics has initiated a Phase 1 clinical trial for its SADA technology platform, dosing the first patient in a study targeting GD2-positive tumors, including small cell lung cancer, sarcoma, and malignant melanoma. This trial will assess the safety and efficacy of the SADA constructs, which utilize a unique two-step administration process. The multi-center trial aims to enroll approximately 60 patients across various U.S. sites. The SADA platform, licensed from prestigious institutions, aims to enhance targeted cancer treatment while minimizing radiation exposure to normal tissues. This milestone could pave the way for Y-mAbs to establish a significant radiotherapeutic franchise.

Y-mAbs Therapeutics reported record net product revenues of $16.4 million for Q4 2022, reflecting a 71% year-over-year increase and a 31% sequential rise from Q3 2022. The fourth quarter also saw net revenues of $31.5 million, an 87% increase for the year totaling $65.3 million. The company secured conditional marketing authorization for DANYELZA in China, with plans for a launch in H1 2023. Cash and cash equivalents stood at $105.8 million as of December 31, 2022, anticipated to last until Q1 2026. Guidance for 2023 includes expected DANYELZA revenues of $60-$65 million and operating expenses of $115-$120 million.

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) will release its financial results for the year ended December 31, 2022, on March 30, 2023, after U.S. market close. A conference call will follow on March 31, 2023, at 9:00 a.m. ET, featuring key executives including Chairman and Interim CEO Thomas Gad. Y-mAbs specializes in developing novel cancer therapies, including FDA-approved DANYELZA® and registration-stage omburtamab. The company’s innovative platforms include bispecific antibodies targeted towards cancer treatments.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced that the European Medicines Agency (EMA) has approved its Pediatric Investigation Plan (PIP) for naxitamab, aimed at treating pediatric patients with high-risk neuroblastoma. The decision follows a positive opinion from the EMA’s Pediatric Committee. The approved PIP is a vital step, as it is necessary for filing a Marketing Authorization Application (MAA) in Europe. DANYELZA (naxitamab-gqgk), developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs, is already FDA-approved for similar indications.

Y-mAbs Therapeutics (Nasdaq: YMAB) has announced a strategic restructuring plan aimed at extending its cash runway and prioritizing the commercialization of DANYELZA. The company expects a 28% reduction in annual operating expenses for 2023, targeting $115-120 million, and plans to decrease cash burn to $50-55 million. DANYELZA's projected net revenues for 2023 are estimated at $60-65 million. The restructuring includes a 35% workforce reduction and deprioritization of several pipeline programs, focusing on DANYELZA growth and the SADA technology development.

Y-mAbs Therapeutics announced the participation of founder and President Thomas Gad at the virtual 41st Annual J.P. Morgan Healthcare Conference, scheduled for January 11, 2023, at 5:15 PM EST. Y-mAbs, listed on Nasdaq as YMAB, focuses on developing innovative, antibody-based cancer treatments. The company’s portfolio includes the FDA-approved DANYELZA® and the registration-stage candidate OMBLASTYS®. The press release also outlines potential forward-looking statements regarding product developments, clinical studies, and market strategies.

Y-mAbs Therapeutics (Nasdaq: YMAB) has announced a distribution agreement with WEP Clinical for an early access program for its cancer treatment, DANYELZA (naxitamab-gqgk), in Europe. DANYELZA, a humanized monoclonal antibody targeting GD2, is already FDA-approved for high-risk neuroblastoma in the U.S. The initial rollout will be in Spain and France, with potential expansion to other regions. This partnership aims to provide European patients access to DANYELZA while Y-mAbs continues to develop its oncology pipeline.

Y-mAbs Therapeutics (YMAB) announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion regarding the marketing authorization of omburtamab for treating CNS/leptomeningeal metastasis from neuroblastoma in Europe. The committee deemed it impossible to conclude the drug's effectiveness without a randomized comparator in the main study. CEO Thomas Gad expressed disappointment, emphasizing the critical need for approved therapies in this area. The company will evaluate the implications of this decision on the omburtamab program.

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced a clinical update for naxitamab and its SADA technology programs at an R&D event on December 14, 2022. The Company discussed significant advancements, including a proprietary SADA construct targeting CD38 for Non-Hodgkin’s Lymphoma and updates on GD2-SADA in Phase 1 trials. Also highlighted was the potential label expansion for DANYELZA® (naxitamab-gqgk) into osteosarcoma, along with plans for a Phase 2 trial in high-risk neuroblastoma patients. The event featured key presentations from the Company's leadership.