MacroGenics Inc (NASDAQ: MGNX) is flying early on in the pre-market hours this morning, and for good reason. The company announced positive clinical data from a Phase 3 trial, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The data;
- what we’re seeing from MGNX stock as a result; and
- what we’ll be watching for ahead.
MGNX Is Climbing On Strong Clinical Data
As mentioned above, MacroGenics is having an incredibly strong start to the trading session in the pre-market hours this morning after releasing positive clinical data. The data came from the company’s Phase 3 study of margetuximub.
During the Phase 3 SOPHIA study, the treatment was being assessed as an option for HER2-positive metastatic breast cancer patients.
In the release, MGNX said that the trial met its primary endpoint. This was the prolongation of progression-free survival in patients treated with the combination of margetuximab plus chemotherapy when compared to trastuzumab plus chemotherapy.
The results show that patients in the margetuximab arm of the study experienced a 24% risk reduction in PFS. Also, about 85% of patients in the study were carriers of the CD16A (fcyRIIIa) 158F allele.
CD16A (fcyRIIIa) 158F allele has previously been associated with diminished clinical response to HERCEPTIN and other antibodies. In this subpopulation, patients in the margetuimab arm experienced a 32% risk reduction in PFS.
Based on the strong clinical results, MGNX said that it is expecting to submit a Biologics License Application to the United States Food and Drug Administration in the second half of this year.
In a statement, Hope S. Rugo, M.D., Cirector of Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, had the following to offer:
There are currently no approved agents for the treatment of patients with metastatic HER2+ breast cancer who have previously received trastuzumab, pertuzumab and ado-trastuzumab emtansine. If margetuximab is approved, based on SOPHIA data, I believe that this agent could become a valuable treatment option for these patients.
The above statement was followed up by Scott Koenig, M.D., Ph.D., President and CEO at MGNX. Here’s what he had to say:
We are pleased with the SOPHIA clinical results and are especially grateful to the patients, their caregivers, trial investigators and site personnel who participated in the study. I would also like to thank the entire MacroGenics team and our business partners who worked diligently to bring margetuximab to the clinic and execute the SOPHIA study. Our Fc-engineered, immune-enhanced molecule has demonstrated a superior outcome in a head-to-head study against HERCEPTIN. We look forward to additional opportunities to develop margetuximab in other HER2-positive breast and gastric cancer populations.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to MacroGenics, the news proved to be incredibly positive. After all, the strong clinical data will likely support the submission of a Biologics License Application with the FDA, potentially opening the door to a strong stream of revenue. So, it’s not surprising to see that excited investors are sending the stock on a run upward. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:15), MGNX is trading at $21.05 per share after a gain of $9.94 per share or 89.47% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on MGNX. In particular, we’re interested in following the story surrounding the Company’s continued work to bring margetuximab to market following the release of today’s positive data. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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