It’s not too late to buy Moderna (NASDAQ:MRNA). While the novel coronavirus-related shares have exploded from a February 2020 low of $17.91 to a high of $56.38, there’s still plenty of upside potential for the MRNA stock.
Granted, Moderna does face plenty of competitive threat. Gilead (NASDAQ:GILD), for example, just said preliminary results of a Covid-19 vaccine trial “showed at least 50% of patients treated with a five-day dosage of antiviral drug remdesivir improved and more than half were discharged from the hospital within two weeks,” CNBC reported. “The company also said another trial by the National Institute of Allergy and Infectious Diseases met its main goal.”
However, a study in China showed the drug didn’t have a statistically significant benefit over the placebo, The Wall Street Journal reported.
Inovio Pharmaceuticals (NASDAQ:INO) just started human trials after getting U.S. FDA approval earlier this month. Should the vaccine show solid results, it could progress to Phase 2.
However, even with that news, Moderna still has plenty of room to run.
Moderna Just Submitted IND to FDA for Phase 2 Study
Not only did Moderna win a $483 million U.S. award to develop a vaccine, it just submitted an Investigational New Drug (IND) application to the FDA seeking approval to move into Phase 2 trials for its mRNA vaccine.
Of course, approval is contingent on Phase 1 studies conducted by the National Institute of Allergy and Infectious Diseases.
“Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency,” said Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “We look forward to launching this Phase 2 study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273.”
Once approved, Phase 2 will include two groups of volunteers. One will include a total of 600 participants. Half will be between the ages of 18 to 55. The other will include those 55 and older. Each participant will be randomly assigned to a placebo, or the two total doses of the vaccine. Then, after a year, all will be followed up on.
So far, Moderna has received initial feedback from the FDA on the design of the planned Phase 2 trial, though, and is expected to begin in the second quarter of 2020. Should all go well, the company could move into Phase 3 studies this fall.
Meanwhile, the company said on May 1 that it will team with Swiss drugmaker Lonza Group (NASDAQ: LZAGY) to manufacture up to a billion doses per year of mRNA-1273, establishing manufacturing capabilities at Lonza’s facilities in the U.S. and Switzerland. The companies expect to produce the first batches of mRNA-1273 at Lonza’s U.S. facility by July.
There’s hope this could do the trick, and wipe out the virus.
“This is the 10th vaccine we’ve put in the clinic with Moderna’s mRNA platform,” the pharma firm’s CEO, Stéphane Bancel said. “We expect the safety and tolerability profile of the Moderna Covid-19 vaccine to be very similar from the other vaccines. And so, I think we start to be in a place where we are cautiously optimistic.”
Granted, there are no guarantees with drug development. But there’s high hope that a company like Moderna can help wipe out this global virus.
“So far, Moderna has conducted early trials with success on nine vaccine candidates, including respiratory syncytial virus (RSV), human metapneumovirus (hMPV) and parainfluenza virus (PIV3), influenza H7N9, cytomegalovirus (CMV), Zika, Epstein-Barr, chikungunya and, of course, is running the trial on the novel coronavirus that causes COVID-19,” as noted by Biospace.
While some may also argue MRNA stock has become too expensive, it hasn’t. There’s still plenty of upside remaining, as Moderna progresses in its trials.
Ian Cooper, an InvestorPlace.com contributor, has been analyzing stocks and options for web-based advisories since 1999. As of this writing, he did not hold a position in any of the aforementioned securities.