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Y-mAbs Therapeutics, Inc. (YMAB)

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41.38+1.38 (+3.45%)
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Neutralpattern detected
Previous Close40.00
Open40.66
Bid41.43 x 800
Ask41.60 x 900
Day's Range39.68 - 41.68
52 Week Range14.16 - 50.49
Volume91,906
Avg. Volume151,921
Market Cap1.656B
Beta (5Y Monthly)1.35
PE Ratio (TTM)N/A
EPS (TTM)-2.99
Earnings DateAug 07, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est47.33
  • GlobeNewswire

    Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma

    NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced clinical updates on naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma and omburtamab for CNS/leptomeningeal metastasis from neuroblastoma. Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. The naxitamab data was presented by Dr. Jaume Mora from SJD Barcelona Children's Hospital, and the omburtamab data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center (“MSK”).Naxitamab In a poster presentation, Dr. Mora presented data from the Company’s pivotal 201 multicenter study. The central independent evaluation showed an overall rate of response (“ORR”) of 68% and the rate of complete response (“CR”) was 59% for the 22 patients. In addition, bone marrow clearance was observed with complete response in 7 of 9 patients, who had positive bone marrow at trial start. The median duration of response with long-term follow-up was 27 weeks.“We are excited to share this new clinical data for naxitamab, which we believe could be a very important new treatment for high-risk neuroblastoma patients, if approved. Naxitamab is administered in an outpatient setting, and the FDA previously set a PDUFA date of November 30, 2020,” said Thomas Gad, founder, Chairman and President.Omburtamab In an oral presentation, Dr. Kramer presented planned interim results for 17 patients enrolled on the Company’s pivotal 101 multicenter study. The study showed a twelve-months overall survival (“OS”) of 87%, with a median follow-up of 26 weeks. This compares to an OS of approximately 30% in a historic control group previously disclosed by the Company.“The preliminary OS results from the multicenter Study 101 are encouraging and appears almost identical to the results of Study 03-133, which was conducted at MSK. While recruitment is still ongoing, we are very pleased to see the preliminary omburtamab data in the multicenter setting appearing supportive of the conclusions from the MSK data. We believe the preliminary survival curves are very similar to the original MSK data, and this is good news for children with CNS/leptomeningeal metastasis from neuroblastoma,” said Claus Moller, Chief Executive Officer.Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs.About Y-mAbsY-mAbs is a development-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates - naxitamab and omburtamab - which target tumors that express GD2 and B7-H3, respectively.Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development and commercialization plans; current and future clinical and pre-clinical studies and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; rate and degree of market acceptance and clinical utility as well as pricing and reimbursement levels; retaining and hiring key employees; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position and strategy; additional product candidates and technologies; collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of our cash and cash equivalents, and the need for, timing and amount of any future financing transaction; our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements; developments relating to our competitors and our industry; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K and in our other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.“Y-mAbs” is a registered trademark of Y-mAbs Therapeutics, Inc.Contact:Y-mAbs Therapeutics, Inc. 230 Park Avenue, Suite 3350 New York, NY 10169 USA +1 646 885 8505 E-mail: info@ymabs.com

  • GlobeNewswire

    Y-mAbs Announces FDA Clearance of IND for its Lutetium-177 Labeled Omburtamab Antibody

    NEW YORK, Oct. 14, 2020 (GLOBE NEWSWIRE) --  Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children. Medulloblastomas are invasive, rapidly growing tumors that, unlike most brain tumors, spread through the cerebrospinal fluid and frequently metastasize to different locations along the surface of the brain and spinal cord. 177Lu-omburtamab-DTPA embodies the Company’s naked omburtamab antibody radiolabeled with lutetium-177, using DTPA to chelate the lutetium radioisotope to the antibody. Lutetium-177 is a beta-emitter with a half-life of 6.7 days and a maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue penetration of approximately 1 mm.We anticipate that an international multicenter Phase 1/2 clinical trial will be initiated for the screening of pediatric patients with medulloblastoma during the fourth quarter of 2020.“Based on our clinical experience with 131I-omburtamab for B7-H3 positive brain metastasis, we are excited to see 177Lu-omburtamab-DTPA make its way to the clinic to establish the safety profile and to determine the maximum tolerated dose. In this study, we hope to leverage our clinical experience from treating 27 medulloblastoma patients with 131I-omburtamab, again using indwelling catheters for intracerebroventricular drug delivery,” said Thomas Gad, founder, Chairman and President.Dr. Claus Moller, Chief Executive Officer further notes, “Children with medulloblastoma represent a clear unmet medical need, and we are very pleased to move this product to the clinic. In addition, we have submitted a separate IND for a basket trial in B7-H3 positive CNS/LM cancers in adults to leverage our experience from treating more than 25 adults with 131I-omburtamab. We expect to initiate the study for the first adult patients to be treated with 177Lu-omburtamab-DTPA during the fourth quarter of 2020, and we are genuinely thrilled to widen our clinical reach to include adult indications.”Researchers at Memorial Sloan Kettering (“MSK”) developed the omburtamab antibody, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.About Y-mAbsY-mAbs is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development and commercialization plans; current and future clinical and pre-clinical studies and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; rate and degree of market acceptance and clinical utility as well as pricing and reimbursement levels; retaining and hiring key employees; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position and strategy; additional product candidates and technologies; collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of our cash and cash equivalents, and the need for, timing and amount of any future financing transaction; our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements; developments relating to our competitors and our industry; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K and in our other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.“Y-mAbs” is a registered trademark of Y-mAbs Therapeutics, Inc.Contact:Y-mAbs Therapeutics, Inc. 230 Park Avenue, Suite 3350 New York, NY 10169 USA+1 646 885 8505E-mail: info@ymabs.com

  • GlobeNewswire

    Bragar Eagel & Squire, P.C. Is Investigating Evolus, Lizhi, Iovance Biotherapeutics, and Y-mAbs Therapeutics and Encourages Investors to Contact the Firm

    NEW YORK, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder law firm, is investigating potential claims against on behalf of investors of Evolus, Inc. (NASDAQ: EOLS), Lizhi, Inc. (NASDAQ: LIZI), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), and Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB). Our investigation concerns whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices. Additional information about each potential case can be found at the link provided. Evolus, Inc. (NASDAQ: EOLS) Evolus is a California based medical aesthetics company. The Company and its South Korean partner, Daewoong Pharmaceutical Co. (“Daewoong”) developed Jeuveau, a competitor to Allergan’s Botox. Jeuveau has recently become a strong, more affordable competitor of Botox.On July 6, 2020, Judge David Shaw of the International Trade Commission issued a preliminary ruling in a trade secrets action accusing Evolus and Daewoong of having developed Jeuveau, using trade secrets stolen from Allergan’s partner company, Medytox. In a non-binding decision, the judge sided with Allergan and Medytox and recommended a 10-year ban on Jeuveau imports to the United States.On this news, shares of Evolus fell sharply, from $5.55 per share to close at $3.25 per share on July 7, 2020, representing a loss of more than 41%.For more information on our investigation into Evolus go to: https://bespc.com/EOLSLizhi, Inc. (NASDAQ: LIZI) On or around January 17, 2020, Lizhi conducted its initial public offering (“IPO”), issuing 4.1 million American depositary shares (“ADSs”) priced at $11.00 per ADS.Since the IPO, Lizhi’s ADS price has fallen precipitously, closing at $2.77 per ADS on September 22, 2020, representing a decline of 74.82% from the IPO price.For more information on the Lizhi investigation go to: https://bespc.com/LIZIIovance Biotherapeutics, Inc. (NASDAQ: IOVA) On October 5, 2020, Iovance issued a press release “provid[ing] a regulatory update for its tumor-infiltrating lymphocyte (TIL) therapy lifileucel in metastatic melanoma.” Specifically, Iovance advised investors that “the Company and the [U.S. Food and Drug Administration] have not been able to agree on the required potency assays to fully define its TIL therapy, which is required as part of a BLA [Biologics License Application] submission. The Company is continuing to refine the information from its current potency assays and simultaneously developing additional assays. As a result of these developments, the BLA submission is not expected by the end of 2020.”On this news, Iovance’s stock price fell $3.96 per share, or 12.35%, to close at $28.10 per share on October 6, 2020.For more information on the Iovance investigation go to: https://bespc.com/IOVAY-mAbs Therapeutics, Inc. (NASDAQ: YMAB)On October 5, 2020, Y-mAbs issued a press release disclosing receipt of “a Refusal to File letter from the U.S. Food and Drug Administration (‘FDA’) regarding the Biologics License Application (‘BLA’) for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, which was submitted in August 2020.” Y-mAbs advised investors that “[u]pon preliminary review, the FDA determined that certain parts of the Chemistry, Manufacturing and Control ('CMC') module and the Clinical module of the BLA require further detail.”On this news, y-mAbs’s stock price fell $3.57 per share, or 8.56%, to close at $38.13 per share on October 6, 2020.For more information on the Y-mAbs investigation go to: https://bespc.com/YMABAbout Bragar Eagel & Squire, P.C.: Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.Contact Information: Bragar Eagel & Squire, P.C. Brandon Walker, Esq. Melissa Fortunato, Esq. Marion Passmore, Esq. (212) 355-4648 investigations@bespc.com www.bespc.com