Y-Mabs Therapeutics Inc

Y-mAbs Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on the development and commercialization of antibody based therapeutic products for the treatment of cancer. Its services include discovery, protein engineering, clinical and regulatory. Y-mAbs Therapeutics was founded by Thomas Gad in April 2015 and is headquartered in New York, NY.

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Y-Mabs Therapeutics reports record revenues and strategic growth initiatives

Y-Mabs Therapeutics demonstrated strong financial performance in Q4 2022, with record revenues and effective cost management.
The company's focus on product development and market expansion, coupled with strategic restructuring, positions it for sustainable growth.
While facing financial challenges and competitive pressures, Y-Mabs Therapeutics has opportunities for portfolio expansion and market penetration.

Y-Mabs Therapeutics Inc achieves record revenue, eyes international expansion

Y-Mabs Therapeutics Inc reported strong performance in Q1 2023, driven by record net product revenue and positive sales trends for DANYELZA.
The company's focus on R&D, commercialization efforts, and strategic partnerships positions it well for future growth and market expansion.
While facing challenges such as market competition and restructuring, Y-Mabs Therapeutics Inc has opportunities to capitalize on its innovative technologies and market presence.
With updated financial guidance and a clear roadmap for product development, the company is poised for continued success and revenue growth in 2023.

Y-Mabs reports robust Q2 earnings, eyes international expansion and label growth

Y-Mabs Therapeutics Inc demonstrated strong financial performance with notable revenue growth for DANYELZA and advancements in their SADA platform.
While facing challenges in competitive dynamics and treatment optimization, the company is strategically positioned for international market expansion and revenue diversification.
Opportunities lie in market penetration strategies, upcoming label expansions, and continued product development efforts, indicating a positive outlook for future growth and innovation.

Y-Mabs Therapeutics reports strong Q3 performance and eyes oncology expansion

Y-Mabs Therapeutics showcased robust financial performance, strong commercial traction for DANYELZA, and promising advancements in the SADA platform.
While facing challenges in scalability and dose optimization, the company's strategic strengths lie in leadership changes, clinical progress, and market penetration.
Opportunities for growth include expanding indications, optimizing treatment protocols, and enhancing visibility through data presentations and partnerships.

Y-mAbs reports strong Q4 earnings, eyes global expansion and program innovations

Y-mAbs Therapeutics showcased robust financial performance in Q4 2023, driven by strong DANYELZA net product sales and revenue growth.
Effective cost management, expansion plans into key markets, and enhanced marketing efforts position the company for continued success.
While facing challenges in managing expenses and addressing analyst inquiries, Y-mAbs has opportunities for growth through international expansion and program innovations.

Y-mAbs reports record DANYELZA sales, eyes global expansion and innovation

Y-mAbs Therapeutics showcased robust financial performance with record DANYELZA sales, underpinned by strategic expansion efforts and progress in clinical programs.
While facing questions on growth strategies and potential seasonality challenges, the company's strong balance sheet and focus on innovation position it well for future success.
By emphasizing responsible capital allocation, global expansion, and advancements in cancer treatment options, Y-mAbs is poised to navigate challenges and seize opportunities for sustained growth.

Y-mAbs Therapeutics reports revenue growth and promising clinical outcomes

Y-mAbs Therapeutics Inc. delivered solid financial performance, strong product sales, and promising clinical trial outcomes in Q2 2024, positioning the company for continued growth.
While facing challenges in managing cash burn and sustaining revenue growth, the company's commitment to innovation and patient care presents opportunities for future success.
With a revised revenue guidance and focus on advancing novel therapies, Y-mAbs Therapeutics Inc. remains dedicated to improving patient lives and driving growth in the biopharmaceutical sector.

Y-Mabs Therapeutics reports mixed Q3 performance with growth opportunities

Y-Mabs Therapeutics faced challenges with declining DANYELZA revenues outside the U.S.
However, the company demonstrated strengths in securing long-term exclusivity and expanding market reach.
Opportunities lie in leveraging partnerships, exploring new targets, and ongoing clinical trials.
Maintaining financial stability and meeting full-year guidance are key priorities for future growth.

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NEW YORK, June 25, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Committee for Orphan Medicinal Products (“COMP”) of the European Medicines Agency (“EMA”) has recommended the granting of orphan medicinal product designation (“OMPD”) in the European Union (“EU”) for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma. The positive opinion from the EMA's COMP has been sent to the European Commission (“EC”), which is expected to grant the orphan drug designation within 30 days.

Y-mAbs' 177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Receives Positive Opinion on Orphan Medicinal Product Designation by EMA

NEW YORK, June 23, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it has recently concluded a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.

Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma

NEW YORK, June 04, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Dr. Jaume Mora, M.D., Ph.D. from SJD Barcelona Children's Hospital will present frontline data for DANYELZA and GM-CSF for consolidation of high-risk neuroblastoma (“HR-NB”) patients in complete remission at the American Society of Clinical Oncology (“ASCO”) Virtual Annual Meeting on June 4, 2021

Y-mAbs Announces Frontline Data for DANYELZA® (naxitamab-gqgk) in High-Risk Neuroblastoma

NEW YORK, June 04, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Dr. Mark Souweidane, Memorial Sloan Kettering Cancer Center (“MSK”) and Weill Cornell Medicine will present interim phase 1 dose-escalation data for omburtamab for diffuse intrinsic pontine glioma (“DIPG”) at the American Society of Clinical Oncology (“ASCO”) Virtual Annual Meeting on June 4, 2021

Y-mAbs Announces Update on Omburtamab for DIPG

NEW YORK, May 19, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that it has entered into an exclusive distribution agreement with Adium Pharma S.A. (“Adium”) to be the exclusive distributor in Latin America of the Company's antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.

Y-mAbs Enters into Exclusive Distribution Agreement with Adium Pharma S.A. for DANYELZA® (naxitamab-gqgk) and Omburtamab in Latin America

NEW YORK, May 13, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Nai-Kong V. Cheung, MD, PhD, Enid A. Haupt Endowed Chair, Pediatric Oncology, Memorial Sloan Kettering Cancer Center (“MSK”) will present a research update on the Company's SADA technology platform at PEGS Boston Virtual Conference on May 13, 2021 at 1:20 p.m. Eastern Time. The SADA technology was licensed by the Company from MSK and the Massachusetts Institute of Technology (“MIT”).

Y-mAbs Announces Update on SADA Technology

Y-mAbs Therapeutics, Inc. (YMAB) CEO Claus Moller on Q1 2021 Results - Earnings Call Transcript

YmAbs Therapeutics, Inc. (YMAB) delivered earnings and revenue surprises of 22.95% and -91.91%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?

YmAbs Therapeutics, Inc. (YMAB) Surpasses Q1 Earnings Estimates

NEW YORK, April 29, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) today announced that it will report its financial results for the first quarter ended March 31, 2021 on Thursday, May 6, 2021, after the close of the U.S. financial markets. The announcement will be followed by a conference call and webcast with the investment community on Friday, May 7, 2021, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

Y-mAbs to Announce First Quarter 2021 Financial and Operating Results on May 6, 2021

NEW YORK, April 27, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Company has submitted its Marketing Authorization Application (“MAA”) to the European Medicines Agency for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. Omburtamab is an investigational, monoclonal antibody that targets B7-H3 and is radiolabeled before intraventricular central nervous system (“CNS”) administration. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.

Y-mAbs Submits Omburtamab Marketing Authorization Application to the European Medicines Agency

Y-mAbs Therapeutics Inc (NASDAQ: YMAB) recently concluded a Type B meeting with the FDA regarding omburtamab in CNS/leptomeningeal metastasis from neuroblastoma.  The company received requests from the agency for additional data concerning the granularity of data from identified historical control groups.

Y-mAbs Asked To Submit Additional Granularity Of Data For Omburtamab In Nerve Tissue Cancer

NEW YORK, April 12, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Dr. Sebastian Chung from Memorial Sloan Kettering Cancer Center (“MSK”) presented a virtual poster discussing the SADA technology platform for pre-targeted radioimmunotherapy against GPA33 in a xenograft model of colorectal peritoneal carcinomatosis at the American Association for Cancer Research (“AACR”) Annual Meeting on April 10, 2021.

Y-mAbs Announces GPA33-SADA Data Presented at AACR

Y-mAbs Therapeutics' (YMAB) CEO Claus Moller on Q4 2020 Results - Earnings Call Transcript

NEW YORK, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a development-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today reported financial results for 2020.

Y-mAbs Announces 2020 Financial Results and Recent Corporate Developments

NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced the closing of its public offering of 2,804,878 shares of its common stock, at a public offering price of $41.00 per share, which includes the exercise in full of the underwriters' option to purchase 365,853 additional shares of common stock. The aggregate gross proceeds to Y-mAbs, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately $115 million. All of the shares of common stock were offered by the Company. Y-mAbs' common stock is listed on The Nasdaq Global Select Market under the ticker symbol "YMAB."

Y-mAbs Therapeutics, Inc. Announces Closing of Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares

NEW YORK, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) today announced that it will report its financial results for the fiscal year ended December 31, 2020 on Thursday, February 25, 2021, after the close of the U.S. financial markets. The announcement will be followed by a conference call and webcast with the investment community on Friday, February 26, 2021, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

Y-mAbs to Announce 2020 Financial and Operating Results on February 25, 2021

Y-mAbs Therapeutics Inc (NASDAQ: YMAB) priced its public offering of 2.4 million common shares at $41 per share, for gross proceeds of approximately $100 million. Underwriters have an option to purchase up to an additional 365,853 shares.

Y-mAbs Therapeutics Raises $100M Via Equity To Fund Commercial Rollout Of Neuroblastoma Med

NEW YORK, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced the pricing of its public offering of 2,439,025 shares of its common stock at a public offering price of $41.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $100.0 million. All of the shares are being offered by Y-mAbs. In addition, Y-mAbs has granted the underwriters a 30-day option to purchase up to an additional 365,853 shares of common stock at the public offering price, less the underwriting discounts. The offering is expected to close on February 22, 2021, subject to the satisfaction of customary closing conditions.

Y-mAbs Announces Pricing of Public Offering of Common Stock

NEW YORK, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced the commencement of a registered underwritten public offering of up to $100 million in shares of its common stock. All shares in the offering are expected to be offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to $15 million in shares of its common stock.

Y-mAbs Announces Proposed Public Offering of Common Stock

NEW YORK, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Dr. Claus Møller, MD, Ph.D., Chief Executive Officer of Y-mAbs Therapeutics will provide an overview and update on the company's business at the virtual 39th Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, January 12, 2021, at 10:00 AM Eastern Standard Time. The presentation can be accessed via a live webcast.

Y-mAbs Therapeutics to Present At 39th Annual J.P. Morgan Healthcare Conference

NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it has entered into a definitive agreement to sell its Priority Review Voucher (“PRV”) to United Therapeutics Corporation (Nasdaq: UTHR), based on an agreed valuation of $105 million.

Y-mAbs Announces Sale of Priority Review Voucher

Y-mAbs Therapeutics recently had its first approval. Its second drug, despite some hiccups, is on its way to the market.

Y-mAbs Therapeutics: Further Upside After Approval

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NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that it has entered into a license agreement with SciClone Pharmaceuticals International Ltd (“SciClone”) to be the exclusive co-development and commercialization partner of the Company's antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in China. DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration (“FDA”) on November 25, 2020 and is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment 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. The Company plans to resubmit its Biologics License Application (“BLA”) to the FDA for omburtamab by the end of 2020 or in early 2021.

Y-mAbs Signs License Agreement with SciClone for DANYELZA® (naxitamab-gqgk) and Omburtamab in China

NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that it has entered into a distribution agreement with Swixx BioPharma AG (“Swixx”) to be the exclusive distributor of the Company's antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in Eastern Europe, including Russia. DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration (“FDA”) on November 25, 2020 and is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment 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. The Company plans to resubmit its (“BLA”) to the FDA for omburtamab by the end of 2020 or in early 2021.

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