MacroGenics (MGNX) announced positive results from SOPHIA

MacroGenics announced positive results from SOPHIA, a Phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients

• The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to patients in the trastuzumab arm (HR=0.76, p=0.033). Notably, approximately 85% of patients in the study were carriers of the CD16A (Fc?RIIIa) 158F allele, which has been previously associated with diminished clinical response to HERCEPTIN and other antibodies.
• MacroGenics anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the second half of 2019.

A gene mutation that makes an excess of the HER-2 protein is present in about 15% of primary invasive breast cancers, according to UpToDate, an evidence-based medical resource used by clinicians. This particular trial showed longer progression-free survival in patients treated with a combination of margetuximab and chemotherapy compared to those on trastuzumab (brand name Herceptin) and chemotherapy, a standard-of-care treatment. The company also said approximately 85% of patients in the study were carriers of the CD16A 158F allele, a gene variation has been associated with a reduced clinical response to Herceptin and other antibodies. MacroGenics said it plans to submit a biologics license application to the U.S. Food and Drug Administration in the second half of 2019.

** charts before announcement ** 

 

MacroGenics (MGNX) reported earnings on Tue 27 Feb 2018 (a/h)

Biotechnology company
Headquarters: Rockville, MD
Founded: 2000
macrogenics.com

** charts 3rd day after earnings **

   

• MacroGenics tops 4Q profit forecasts

ROCKVILLE, Md. (AP) _ MacroGenics Inc. (MGNX) on Tuesday reported fourth-quarter net income of $105.7 million, after reporting a loss in the same period a year earlier.

The Rockville, Maryland-based company said it had profit of $2.80 per share.

The results exceeded Wall Street expectations. The average estimate of seven analysts surveyed by Zacks Investment Research was for earnings of $2.58 per share.

The biopharmaceutical company posted revenue of $152.4 million in the period, missing Street forecasts. Five analysts surveyed by Zacks expected $152.6 million.

For the year, the company reported that its loss narrowed to $19.6 million, or 54 cents per share. Revenue was reported as $157.7 million.

MacroGenics shares have risen 26 percent since the beginning of the year. In the final minutes of trading on Tuesday, shares hit $23.95, an increase of 14 percent in the last 12 months.

MacroGenics (MGNX) : 8-month performance

MacroGenics (MGNX) : 6-month performance

MacroGenics (MGNX) began trading on the NASDAQ on 10 October 2013

The Rockville, Maryland, company is developing monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases. It does not have any approved drugs and its most advanced experimental drug is in mid-stage clinical testing.

MacroGenics follows at least 30 biotech companies that have gone public in 2013, which has marked a comeback for the IPO market in life sciences after the deals became scarce in the aftermath of the 2008 financial crash. (For an update on the 2013 IPO trend, check out this feature.)

A comeback story itself, MacroGenics recovered from a busted partnership with Eli Lilly ($LLY) after a late-stage trial failure involving their preventive therapy for Type 1 diabetes called teplizumab in 2010. Its recovery resulted from a string of partnerships on next-gen antibody drugs with Pfizer ($PFE), Servier, Gilead ($GILD) and Boehringer Ingelheim. The company says it is hunting for a new collaborator for teplizumab too after recent upbeat results in a midstage study.

MacroGenics CEO & co-founder Dr. Scott Koenig

MacroGenics, Inc., a clinical-stage biopharmaceutical company, focuses on discovering and developing monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases. Its products include Margetuximab, a monoclonal antibody that targets human epidermal growth factor receptor 2-expressing tumors, including breast, gastroesophageal, bladder, and other cancers; MGA271, an Fc-optimized monoclonal antibody for various solid tumor types; MGD006, a humanized dual affinity re-targeting (DART) molecule for the treatment of hematologic cancers; and MGD007, a DART protein to treat colorectal cancer. The company's products also comprise Teplizumab, a humanized anti-CD3 monoclonal antibody for the treatment of Type 1 Diabetes; and MGD010, a DART-based molecule for autoimmune diseases. The company has strategic collaborations primarily with Les Laboratoires Servier and Institut de Recherches Servier; Gilead Sciences, Inc.; Boehringer Ingelheim International GmbH; and Pfizer, Inc. MacroGenics, Inc. was founded in 2000 and is headquartered in Rockville, Maryland.

Address

9640 Medical Center Drive
ROCKVILLE, MD 20850
United States 

Website 

www.macrogenics.com

Key stats and ratios

	Q2 (Jun '13)	2012
Net profit margin	-2.76%	13.10%
Operating margin	-2.44%	12.86%
EBITD margin	-	14.36%
Return on average assets	-2.96%	14.36%