What happened
Modern (NASDAQ: MRNA) Shares soared 228.3% in the first half, according to data provided by S&P Global Market Intelligence, as the company advanced its COVID-19 vaccine through clinical studies and announced promising early data.
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Moderna became the first company to begin clinical trials with a vaccine as the coronavirus spread worldwide. The company’s vaccine candidate entered a phase 1 study in March, then began phase 2 in May.
Provisional Phase 1 data showed that participants developed at least as many binding and neutralizing antibodies as patients recovered with COVID-19. Binding antibodies signal the presence of a pathogen, while neutralizing antibodies actually block infection.
And that
The coronavirus outbreak has resulted in more than 10 million cases so far and more than half a million deaths, according to the World Health Organization. In the absence of an approved vaccine or treatment, the world is focused on drug manufacturers and vaccine manufacturers that could develop one as soon as possible.
The United States government has even developed an initiative, Operation Warp Speed, to help bring a vaccine to market in January. As part of that program, the Department of Health and Human Services promised Moderna up to $ 483 million in funds.
For Moderna, a clinical-stage company, regulatory approval would be positive in two ways: first, it would give the company its first marketed product, and second, an approval can build investor confidence in the rest of the country. Moderna platform. The technology used to develop the potential vaccine for COVID-19 is the same technology used in the entire Moderna portfolio of potential products.
Now what
Moderna plans to start a phase 3 trial with up to 30,000 participants this month. Trials in earlier stages are ongoing. Although the first results were encouraging, they only dealt with participants between 18 and 55 years old. Modern will now have to show safety and efficacy in older patients. This is significant because the elderly have been among the most vulnerable during this health crisis.
Investors, and eventually regulators, will also be looking for more data on participants’ production of neutralizing antibodies. In the provisional results, that information was available for only eight patients.
And finally, although Moderna was the first to participate in clinical trials, a large pharmaceutical company AstraZeneca (NYSE: AZN) is emerging as another leader. AstraZeneca, in collaboration with the University of Oxford, advanced a vaccine candidate in phase 2/3 trials.
If AstraZeneca becomes a clear leader and wins approval first, Moderna’s big equity gains may have ended. But if Moderna produces solid test results and reaches the finish line first, or together with others, the great performance of this biotech company can continue.
