Y-Mabs Therapeutics Stock Price, News & Analysis

Y-mAbs Therapeutics announced that the FDA granted Rare Pediatric Disease Designation for its ¹⁷⁷Lu-omburtamab-DTPA antibody program aimed at treating medulloblastoma. This designation allows eligibility for a Priority Review Voucher upon potential approval of the biologics license application. The company is advancing this program through Phase 1 clinical trials for both pediatric and adult patients with B7-H3 positive tumors. Y-mAbs now has four compounds with RPDD, highlighting its commitment to addressing unmet medical needs in rare pediatric cancers.

Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) announced the acceptance of two presentations at the International Society of Pediatric Oncology Virtual Annual Congress from October 21-24, 2021. The oral presentation will focus on DANYELZA® for treating high-risk neuroblastoma, while a poster will detail omburtamab for CNS metastasis treatment. Both products are licensed from Memorial Sloan Kettering. DANYELZA is approved for pediatric patients and carries a Boxed Warning for serious side effects. Y-mAbs is advancing its pipeline targeting GD2 and B7-H3 tumor-associated markers.

Y-mAbs Therapeutics announced that its partner SciClone Pharmaceuticals received priority review for the Biologics License Application (BLA) of DANYELZA® (naxitamab-gqgk) for treating high-risk neuroblastoma in China. This priority review aims to expedite the approval process, with potential launch expected by Q1 2022. DANYELZA was recently administered to its first patient in China, marking a significant milestone for the company.

Y-mAbs Therapeutics announced a key opinion leader webinar on DANYELZA data for high-risk neuroblastoma on September 23, 2021. The event will feature experts Jaume Mora and Shakeel Modak presenting frontline and HITS data, respectively. Company leaders Thomas Gad, Steen Lisby, and Claus J. Moller will offer updates on the pipeline and corporate strategy. DANYELZA is FDA-approved for treating high-risk neuroblastoma in pediatric and adult patients. Registration is available here.

Y-mAbs Therapeutics (Nasdaq: YMAB) reported its Q2 2021 financial results, highlighting a net loss of $22.9 million, or ($0.53) per share, a reduction from the $40.4 million loss in Q2 2020. Revenues totaled $11.0 million, driven by $9.0 million from DANYELZA sales. The company had a cash balance of $233.6 million at the end of the quarter, significantly up from $114.6 million at the end of 2020. Y-mAbs is progressing with multiple regulatory submissions, including an accepted BLA submission for DANYELZA in China and an anticipated BLA resubmission for omburtamab by year-end.

Y-mAbs Therapeutics (Nasdaq: YMAB) will report its financial results for Q2 2021 on August 5, 2021, post-market close. This will be followed by a conference call on August 6, 2021, at 9 a.m. ET. Key participants include founder Thomas Gad, CEO Dr. Claus Moller, and CFO Bo Kruse. The company focuses on innovative antibody-based cancer therapies and has an FDA-approved product, DANYELZA, along with a pivotal-stage candidate, omburtamab.

Y-mAbs Therapeutics (NASDAQ: YMAB) announced that SciClone Pharmaceuticals has submitted a Biologics License Application (BLA) for DANYELZA® (naxitamab-gqgk) to China's National Medical Products Administration (NMPA) for treating relapsed/refractory high-risk neuroblastoma. This submission follows FDA approval within just seven months, indicating rapid progress in making the innovative therapy available to pediatric patients in China. Y-mAbs emphasizes the strategic collaboration with SciClone to ensure timely market entry if approved.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced a positive opinion from the EMA's Committee for Orphan Medicinal Products for ¹⁷⁷Lu-omburtamab-DTPA, targeting medulloblastoma. This recommendation supports orphan drug designation, expected to be granted by the European Commission within 30 days. The designation will provide development incentives and 10 years of market exclusivity upon approval, enhancing Y-mAbs' European expansion plans. The company aims to improve treatment options for patients with this rare and life-threatening condition.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced the conclusion of a Type B meeting with the FDA regarding its drug omburtamab for treating pediatric neuroblastoma patients with CNS/metastatic conditions. The company believes it gained clarity on resubmitting the Biologics License Application (BLA) after discussing statistical analysis plans. Y-mAbs plans to provide additional data to the FDA in Q3 2021 and aims for a rolling BLA resubmission by year-end. The approval of omburtamab could fulfill an unmet medical need in pediatric oncology.