B7-H3

MacroGenics Provides Phase 2 TAMARACK Study Early Interim Safety Data and Plans for Future Disclosures

Retrieved on: 
Wednesday, April 3, 2024
Docetaxel, Prostate cancer, ECOG, B7-H3, Patient, Cancer, Autumn, Society, Safety, ASCO, Therapy, PFS, ADC, Annual general meeting, Pharmaceutical industry

As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31.

Key Points: 
  • As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31.
  • The abstract containing this early interim data, based on a January 4, 2024 data cut-off, was not accepted.
  • TAMARACK is an ongoing randomized, open-label, Phase 2 dose selection study assessing the efficacy, safety, and tolerability of two dose levels of vobra duo (2.0 mg/kg and 2.7 mg/kg IV Q4W).
  • At data cutoff (Jan 4, 2024), 182 pts with mCRPC enrolled on TAMARACK, of which 177 received vobra duo.

MacroGenics Provides Update on Corporate Progress and Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Docetaxel, PROTECT, ASC, B7-H3, Therapy, Half-life, Conference call, Bank statement, Telephone, Cancer, Macrogen, GAAP, RPF, ID, Sale, Acute myeloid leukemia, ASCO, B7, Patient, DRI, Syndrome, CD123, Webcast, ADC, Cytokine release syndrome, Enoblituzumab, Research, FDA, IND, Economics, Prostate cancer, D, Fine chemical, Pharmaceutical industry, Vaccine, Security (finance), Sanofi, Conference

ET

Key Points: 
  • ET
    ROCKVILLE, Md., Aug. 09, 2023 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2023.
  • MacroGenics began enrolling the TAMARACK Phase 2 study of vobra duo in patients with mCRPC under an amended protocol during the second quarter.
  • MacroGenics anticipates enrolling a majority of the study patients in 2023 and expects to provide a clinical update in 2024.
  • R&D Expenses: Research and development expenses were $43.2 million for the quarter ended June 30, 2023, compared to $51.7 million for the quarter ended June 30, 2022.

MacroGenics Provides Corporate Update and 2022 Financial Results

Retrieved on: 
Wednesday, March 15, 2023
Gilead Sciences, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, B7-H3, Cytokine release syndrome, ADC, New Board, ASCO, Clinical trial, Investigational New Drug, DRI, Cancer, Macrogen, Half-life, Telephone, Acute myeloid leukemia, CD123, Docetaxel, T1D, Sale, Syndrome, Webcast, RPF, Patient, PSA, Prostate-specific antigen, Parliamentary Information Technology Committee, FDA, ID, Conference call, Ageing, Gilead, D, Prostate cancer, B7, Research, Food, Therapy, IND, Pharmaceutical industry, Vaccine, Medical imaging, Cryptocurrency, Conference, Incyte

ET

Key Points: 
  • ET
    ROCKVILLE, Md., March 15, 2023 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2022.
  • MacroGenics initiated the Phase 2 portion of the TAMARACK study of vobra duo in patients with mCRPC in late 2022.
  • MacroGenics believes that removal of the control arm should allow the Company to provide a clinical update in 2024 potentially in support of a subsequent Phase 3 study in mCRPC.
  • The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm.

Y-mAbs Therapeutics, Inc. (YMAB) Investor Alert: Robbins LLP Reminds Shareholders of Class Action Against Y-mAbs Therapeutics, Inc.

Retrieved on: 
Friday, January 27, 2023
Class Action Lawsuit, Professional Services, Legal, Therapy, B7-H3, Biologics license application, Patient, Efficacy, Committee, News, Database, Letter, CNS, Memorial Sloan Kettering Cancer Center, Complaint, RTF, Marketing, Viability, FDA, Cancer, Pharmaceutical industry

Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.

Key Points: 
  • Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.
  • Shareholders who want to act as lead plaintiff for the class must file their papers by March 20, 2023.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • On this news, Y-mAbs common shares fell $11.56 per share, to close at $3.61 per share on October 31, 2022.

Shareholder Alert: Robbins LLP Informs Investors of Class Action Against Y-mAbs Therapeutics, Inc. (YMAB)

Retrieved on: 
Friday, January 20, 2023
Class Action Lawsuit, Professional Services, Legal, Therapy, B7-H3, Biologics license application, Patient, Efficacy, Committee, News, Database, Letter, CNS, Memorial Sloan Kettering Cancer Center, Complaint, RTF, Marketing, Viability, FDA, Cancer, Pharmaceutical industry

The Class: Robbins LLP informs investors that a shareholder filed a class action on behalf of all investors who purchased shares of Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) common stock between October 6, 2020 and October 28, 2022, for violations of the Securities Exchange Act of 1934.

Key Points: 
  • The Class: Robbins LLP informs investors that a shareholder filed a class action on behalf of all investors who purchased shares of Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) common stock between October 6, 2020 and October 28, 2022, for violations of the Securities Exchange Act of 1934.
  • Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.
  • Shareholders who want to act as lead plaintiff for the class must file their papers by March 30, 2023.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Y-mAbs Therapeutics, Inc. (YMAB) Class Action Notice: Robbins LLP Urges Shareholders to Contact the Firm for Information Regarding Their Rights

Retrieved on: 
Thursday, February 9, 2023
Marketing, RTF, CNS, Complaint, Efficacy, Memorial Sloan Kettering Cancer Center, Cancer, Database, Therapy, Biologics license application, Patient, B7-H3, FDA, Committee, Viability, Letter, News, Pharmaceutical industry

Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.

Key Points: 
  • Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.
  • Shareholders who want to act as lead plaintiff for the class must file their papers by March 20, 2023.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • On this news, Y-mAbs common shares fell $11.56 per share, to close at $3.61 per share on October 31, 2022.

Y-mAbs Therapeutics, Inc. (YMAB) Investor Alert: Robbins LLP Reminds Shareholders of Lead Plaintiff Deadline in Class Action Against Y-mAbs Therapeutics, Inc.

Retrieved on: 
Thursday, February 2, 2023
Marketing, RTF, CNS, Complaint, Efficacy, Memorial Sloan Kettering Cancer Center, Cancer, Database, Therapy, Biologics license application, Patient, B7-H3, FDA, Committee, Viability, Letter, News, Pharmaceutical industry

Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.

Key Points: 
  • Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.
  • The Company's lead product candidate is Omburtamab, a murine monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.
  • Shareholders who want to act as lead plaintiff for the class must file their papers by March 20, 2023.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Y-mAbs Therapeutics, Inc. (YMAB) Shareholder Alert: Robbins LLP Reminds Investors of Class Action Against Y-mAbs Therapeutics, Inc.

Retrieved on: 
Tuesday, January 24, 2023
Marketing, RTF, CNS, Complaint, Efficacy, Memorial Sloan Kettering Cancer Center, Cancer, Database, Therapy, Biologics license application, Patient, B7-H3, FDA, Committee, Viability, Letter, News, Pharmaceutical industry

The Class: Robbins LLP reminds investors that a shareholder filed a class action on behalf of all investors who purchased shares of Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) common stock between October 6, 2020 and October 28, 2022, for violations of the Securities Exchange Act of 1934.

Key Points: 
  • The Class: Robbins LLP reminds investors that a shareholder filed a class action on behalf of all investors who purchased shares of Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) common stock between October 6, 2020 and October 28, 2022, for violations of the Securities Exchange Act of 1934.
  • Y-mAbs is a clinical-stage biopharmaceutical company focused on developing antibody therapeutics and medicines for the treatment of cancer patients of all ages.
  • Shareholders who want to act as lead plaintiff for the class must file their papers by March 20, 2023.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe

Retrieved on: 
Friday, December 16, 2022
CHMP, Neoplasm, Annual report, Failure, Interim, CNS, Security (finance), Neuroblastoma, Government, Marketing, FDA, Cancer, Memorial Sloan Kettering Cancer Center, European Committee on Radiation Risk, B7-H3, GD2, European Directive on Traditional Herbal Medicinal Products, Growth, Therapy, MSK, COVID-19, Patient, Pharmaceutical industry

"This recommendation by the CHMP is disappointing given the significant unmet medical need, which exists for patients with CNS/LM neuroblastoma who have no approved therapies available.

Key Points: 
  • "This recommendation by the CHMP is disappointing given the significant unmet medical need, which exists for patients with CNS/LM neuroblastoma who have no approved therapies available.
  • CHMP considered that it was not possible to conclude on the effectiveness of omburtamab as the main study did not have a randomized comparator.
  • Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products.
  • In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform.

Y-mAbs Announces Pipeline Update

Retrieved on: 
Wednesday, December 14, 2022
Squamous cell carcinoma, Neoplasm, Annual report, Sarcoma, Interim, Osteosarcoma, Security (finance), Marketing, MRCP, SVP, B7-H3, Growth, MBA, Research, MSK, COVID-19, DCH, FDA, Safety, Cancer, Bone marrow, Neuropathic pain, GD2, Melanoma, All India Mahila Congress, Granulocyte-macrophage colony-stimulating factor, MBBS, Cardiac arrest, Neurotoxicity, Transverse myelitis, Patient, Failure, Antibody, Government, Memorial Sloan Kettering Cancer Center, Anaphylaxis, Therapy, Vaccine, Pharmaceutical industry

Investors, analysts, members of the media and the public may access the event via a live webcast .

Key Points: 
  • Investors, analysts, members of the media and the public may access the event via a live webcast .
  • The presentation materials can be found on the Company’s website under the Presentations tab under the heading For Investors.
  • Dr. Rajah, will present an update on DANYELZA® (naxitamab-gqgk), including potential label expansion into osteosarcoma, and a planned multicenter Phase 2 trial in patients with newly diagnosed high-risk neuroblastoma.
  • The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.