What happened
Shares of Moderna (MRNA +1.05%) climbed 53.6% in April, according to data provided by S&P Global Market Intelligence, after the U.S. government offered the company funding to cover development of its coronavirus vaccine candidate all the way through regulatory approval.
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The Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services, is offering as much as $483 million to advance Moderna's mRNA vaccine through clinical trials. The investment also will cover the manufacturing scale-up needed to address the coronavirus crisis.
Moderna's vaccine harnesses the power of messenger RNA, which carries instructions from DNA to the part of our cells that produces the proteins our bodies need to function. Using mRNA, Moderna's products give the body's cells instructions to make proteins to prevent or treat diseases.
So what
BARDA's investment is a significant positive for Moderna, a clinical-stage biotech company, since it assures the funding of this program all the way to the finish line. Among the companies involved in the race to develop a coronavirus vaccine, Moderna was the first to bring a candidate to human trials.
For those two reasons, Modera has a good chance of being the first -- or among the first -- to market if trial data is favorable.
Now what
The National Institutes of Health is currently conducting a phase 1 trial of the vaccine. Enrollment of 45 healthy adults ages 18 to 55 is complete, but the trial protocol has been updated to include six additional study groups that will include older and elderly adults.
Meanwhile, Moderna submitted an Investigational New Drug application to the Food and Drug Administration for a phase 2 study of the vaccine candidate. This study, expected to begin in the second quarter, would evaluate the vaccine's safety, side effects, and ability to spur an immune response. The company may move forward with this step if it is supported by safety data from the phase 1 trial. If these first two stages of clinical tests go well, Moderna said a phase 3 study may begin in the fall.
On May 1, Moderna announced a 10-year collaboration with Lonza Group (LZAGY +0.80%) for the manufacture of its coronavirus vaccine at Lonza facilities in the U.S. and Switzerland.
If all goes well in Moderna's clinical studies, investors can probably expect more gains from the biotech stock in the coming months.
