What happened
After MacroGenics (MGNX 7.00%) updated investors on its clinical-stage drug pipeline and current financial position, its shares are soaring 171% as of 12:45 am EDT Wednesday.
So what
MacroGenics' lead drug candidate is margetuximab, an optimized formulation of the top-selling breast cancer drug Herceptin. After the market's closing bell on Tuesday, the biotech company's management said it remains on track to report final overall survival (OS) data for the phase 3 SOPHIA study of margetuximab in HER2-positive metastatic breast cancer this year. If the data is solid, MacroGenics believes it could get a Food and Drug Administration decision as soon as December 2020.
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Last year, the company announced that in a late-stage study, margetuximab produced progression-free survival (PFS) of 5.8 months, outperforming a 4.9-month PFS for Herceptin.
MacroGenics also said that at the American Society of Clinical Oncology annual meeting this month, it will deliver an oral presentation from its ongoing phase 1 study of MGD013, for advanced solid-tumor patients.
Furthermore, the company offered up a bullish take on its cash runway. It believes the $170.8 million in cash and equivalents on its balance sheet can last it into 2022.
Now what
Overall survival is the gold standard for proving the efficacy of drugs, so a positive readout later this year could ensure it secures market share as an alternative to Herceptin, a blockbuster medication. If the OS data isn't better than Herceptin, margetuximab could still secure an approval on PFS results. But that will depend a lot on the view of the FDA's Oncologic Drugs Advisory Committee, which is meeting in the second half of 2020 to discuss margetuximab's merits.
The fact margetuximab isn't MacroGenics only intriguing drug in development is encouraging, too, so risk-tolerant investors able to withstand an FDA disappointment may want to consider picking up shares, especially if the advisory committee recommends the FDA give margetuximab a green light.
