|Bid||0.00 x 800|
|Ask||0.00 x 900|
|Day's Range||30.97 - 32.86|
|52 Week Range||5.00 - 33.39|
|Beta (5Y Monthly)||2.29|
|PE Ratio (TTM)||N/A|
|Earnings Date||May 03, 2021 - May 07, 2021|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||33.80|
ROCKVILLE, MD, April 10, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 10-15, 2021. “This year’s AACR presentations highlight three antibody-based technologies upon which multiple molecules are being developed at MacroGenics,” said Ezio Bonvini, M.D., Senior Vice President and Chief Scientific Officer of MacroGenics. “We are presenting pre-clinical data on MGC018, our clinical-stage, investigational antibody-drug conjugate (ADC) targeting B7-H3. At clinically relevant dose levels, MGC018 demonstrated potent antitumor activity in vivo in mouse patient-derived xenograft (PDX) models of squamous cell carcinoma of the head and neck (SCCHN). MGC018 is currently being investigated in a Phase 1 dose expansion study in advanced solid tumor cancers, including metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC).” “A second poster demonstrates that margetuximab, our Fc-engineered anti-HER2 mAb developed using our Fc Optimization platform, can upregulate checkpoint molecules on Natural Killer (NK) cells, CD8 T cells and tumor cells, potentially sensitizing them to immune checkpoint blockade. Consistent with this observation, PD-1 and LAG-3 blockade by tebotelimab, our investigational bispecific PD-1 × LAG-3 DART® molecule, enhances margetuximab-mediated NK cell cytolytic activity in vitro,” added Dr. Bonvini. “Finally, our third poster highlights pre-clinical data on IMGC936, an investigational ADAM9-directed ADC being developed in collaboration with ImmunoGen Inc. ADAM9 is highly expressed in a large number of solid tumors and our presentation shows that IMGC936 has activity against multiple solid tumor types in in vivo mouse PDX models. IMGC936 is currently being studied in a Phase 1 clinical trial evaluating safety and pharmacokinetics in cancer patients. Together, these results illustrate the drug development potential of all three technologies MacroGenics is deploying to identify and advance promising anti-cancer drug candidates.” Presentation details are as follows: April 10, 2021, 8:30 AM - 11:59 PM1555 - Enhanced HER2-dependent immune activation by margetuximab, an investigational Fc-engineered anti-HER2 mAb, supports combination with checkpoint blockadeSession PO.IM02.02 - Combination Immunotherapies April 10, 2021, 8:30 AM - 11:59 PM950 - Targeting B7-H3 in squamous cell carcinoma of the head and neck: Preclinical proof-of-concept with the investigational anti-B7-H3 antibody-drug conjugate, MGC018Session PO.ET07.01 - Biological Therapeutic Agents April 10, 2021, 8:30 AM - 11:59 PM1841 - IMGC936, an investigational ADAM9-targeting antibody drug conjugate, is active against patient-derived ADAM9-expressing xenograft modelsSession PO.IM02.10 - Therapeutic Antibodies, Including Engineered Antibodies Posters of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA’s market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. ### CONTACT: Contact: Jim Karrels, Senior Vice President, CFO MacroGenics, Inc. 1-301-251-5172, email@example.com
Provention Bio Inc (NASDAQ: PRVB) revealed it had received a notification on April 2 from the FDA stating that the agency has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. Notably, the FDA expressed concerns over teplizumab pharmacokinetics data and comparability when Lilly first put teplizumab into clinical trials. Regulators assert the PK profiles from Provention’s studies and Lilly’s trials are not the same and asked for more data on April 2. According to the regulators, such concerns mean that the candidate cannot start post-marketing and label discussions. Investors responded sourly to the news after Thursday’s bell, with the stock crashing almost 40%. Provention responded, noting it is “willing to discuss these issues.” Regulators had scheduled a May 27 AdCom to discuss the experimental drug, which will continue as planned. The drug has a long history. In 2007, Eli Lilly And Co’s (NYSE: LLY) and MacroGenics Inc (NASDAQ: MGNX) partnered to develop and commercialize teplizumab. In 2010, teplizumab failed a pivotal late-stage diabetes study undertaken by Eli Lilly, and it handed the rights back to MacroGenics. In 2018, Provention Bio stepped in and in-licensed the drug from MacroGenics, hoping to bring the experimental drug back from the dead. PRVB used teplizumab as their lead drug for a $56 million IPO filing. Teplizumab is an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals. Price Action: PRVB shares plunged 40.7% at $5.77 in the premarket session on the last check Friday. See more from BenzingaClick here for options trades from BenzingaEli Lilly-Incyte's Baricitinib Study In Hospitalized COVID-19 Patients Fails To Meet Main GoalFortress Biotech's Partner Firm Expands Footprint In Dermatology With Qbrexza Acquisition© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
MacroGenics (MGNX) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions could translate into further price increase in the near term.