MacroGenics, Inc. - MGNX STOCK NEWS

MacroGenics, Inc. (NASDAQ: MGNX) has submitted an IND application for MGD024, a bispecific DART molecule targeting CD123 and CD3 for AML. The FDA approved its GMP manufacturing facility for MARGENZA drug substance. However, enrollment for Cohort A of the Phase 2/3 MAHOGANY study of margetuximab is being discontinued. Financial results for Q3 2021 revealed total revenue of $15.7 million, down from $18.3 million in Q3 2020. R&D expenses rose to $49.8 million, leading to a net loss of $52.9 million. The company expects its cash position to fund operations through 2023.

MacroGenics, Inc. (Nasdaq: MGNX) will release its third-quarter 2021 financial results after the market closes on November 2, 2021. A conference call to discuss these results and recent corporate developments will be held on the same date at 4:30 pm ET. Investors can join the call by dialing the appropriate access numbers five minutes prior to the start. The presentation will also be available via a listen-only webcast on the company's Investor Relations website, with a recorded replay accessible for 30 days post-call.

MacroGenics announced promising interim results from Part 1 of the Phase 2/3 MAHOGANY clinical trial for margetuximab, targeting HER2+ gastric cancer. Out of 40 evaluated patients, 21 achieved confirmed responses, exceeding the trial's futility boundaries. The combination therapy demonstrated a 78% tumor shrinkage rate and a median response duration of 10.3 months. The treatment was well tolerated, with only 19% experiencing Grade 3 adverse events. These findings support advancing to Part 2 of the trial, with potential implications for first-line treatment options.

MacroGenics (NASDAQ: MGNX) announced preliminary safety and anti-tumor results from the Phase 1 trial of MGC018, an investigational antibody-drug conjugate. In metastatic castration-resistant prostate cancer (mCRPC), 54% of patients showed ≥ 50% PSA reduction, while 63% of evaluable patients displayed anti-tumor activity. In non-small cell lung cancer (NSCLC), 81% of evaluable patients had anti-tumor activity. The treatment demonstrated a manageable safety profile with only 7% discontinuation due to treatment-related adverse events. Further updates on other cohorts are anticipated.

On September 12, 2021, MacroGenics (Nasdaq: MGNX) announced multiple poster presentations for its investigational product candidates at the ESMO Virtual Conference scheduled for September 16-21, 2021. Key presentations include preliminary results for MGC018, an antibody-drug conjugate targeting advanced solid tumors, and data from the MAHOGANY trial on margetuximab in HER2+, PD-L1+ gastroesophageal adenocarcinoma. The posters will be accessible on the ESMO website and MacroGenics' investor relations page.

MacroGenics announced the final overall survival (OS) results of the SOPHIA Phase 3 study for MARGENZA (margetuximab-cmkb) in HER2-positive metastatic breast cancer. The study showed no statistically significant OS advantage for MARGENZA plus chemotherapy (21.6 months) compared to trastuzumab plus chemotherapy (21.9 months; HR=0.95, P=0.62). However, a subgroup analysis indicated improved OS in patients with the CD16A 158F allele. Safety profiles were consistent with prior reports. Further studies are planned to explore MARGENZA's effects based on CD16A variants.

MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company, announced its participation in several investor conferences in September 2021. The events include Citi’s 16th Annual BioPharma Virtual Conference on September 9, featuring a panel discussion on oncology therapies. Additionally, MacroGenics will engage in a fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15 and another at the 2021 Cantor Virtual Global Healthcare Conference on September 30.

Webcasts of these presentations will be available on the company's investor relations website.

MacroGenics, Inc. (Nasdaq: MGNX) announced its participation in two key conferences in August 2021. The first event is the BTIG Virtual Biotechnology Conference on August 10, where management will engage in a fireside chat at 9:30 am ET and conduct one-on-one meetings. The second is the 12th Annual Wedbush PacGrow Healthcare Conference on August 11, featuring CEO Scott Koenig in a panel discussion titled ADCs – Take Me to Your Tumor at 2:20 pm ET, along with one-on-one meetings. Webcast access for these events is available on their website.

MacroGenics, Inc. (NASDAQ: MGNX) reported its Q2 2021 financial results, highlighting a revenue increase to $30.8 million, up from $20.3 million in Q2 2020, driven by collaborations and MARGENZA sales. The company is progressing with its clinical pipeline, including upcoming data presentations at ESMO. Key financials include a net loss of $39.9 million and total cash and equivalents of $297.3 million as of June 30, 2021. Guidance indicates funding through 2023, contingent on program advancements.