Investors hungry for stocks that could make big movements in short time spans know that the biotech industry is full of them. At any given time, there are dozens of drugmakers facing scheduled events that could send their stock prices rising or falling.
With so many to choose from, it's easy to feel overwhelmed. If you only have enough time to keep up with a handful of biotech catalysts that are on the way soon, these three are well worth your attention.
|Company||Market Cap||New Drug Candidate|
|Biogen (BIIB 3.28%)||$40.3 billion||aducanumab|
|Novavax (NVAX 11.12%)||$13.3 billion||NVX-CoV2373|
|iTeos (ITOS 1.31%)||$968 million||EOS-448|
This company is the first to submit an application to the Food and Drug Administration for a new drug designed to slow the progress of Alzheimer's disease. This ultimately fatal form of dementia affects about one in nine Americans over the age of 65, but there still aren't any drugs to prevent the disease from worsening.
We'll probably find out if the FDA's going to stamp Biogen's golden ticket on or before June 6, the latest proposed action date for aducanumab's long-awaited approval decision. The FDA has already rescheduled the action date for this controversial approval decision twice.
Back in the spring of 2019, independent data monitors hired to watch a pair of identical pivotal studies determined aducanumab had no chance of success, statistically speaking. Instead of accepting defeat, Biogen returned a few months later with a more recent analysis of the data.
This biotech has been on a long and at times tortuous journey to becoming a commercial-stage vaccine manufacturer. Novavax's COVID-19 vaccine, NVX-CoV2373, is its most successful candidate to date thanks to a pivotal study in the U.K. that showed an 89.7% overall efficacy rate earlier this year. Another pivotal study taking place in the U.S. and Mexico that began last December will read out interim results any day now.
With three coronavirus vaccines already authorized, the FDA will most likely wait for confirmation from the ongoing pivotal study with NVX-CoV2373 in the U.S. before considering it for an Emergency Use Authorization. The U.S. government has already ordered enough doses for every adult in the country from Pfizer, Moderna, and Johnson & Johnson (JNJ 1.13%), but recent disruptions to Johnson & Johnson's COVID-19 vaccine could open a window of opportunity for Novavax's relatively simple vaccine candidate.
Although Novavax may have missed the boat in the U.S., NVX-CoV2373's ability to remain stable at temperatures that are already standard along existing vaccine supply lines could lead to heaps of international orders. In February, Novavax agreed to supply the international COVAX program with 1.1 billion doses.
3. iTeos Therapeutics
This cancer-focused biotech start-up made its stock market debut last July, and its lead candidate EOS-448 is scheduled to make a big appearance on Saturday, April 10, at the first session of this year's meeting of the American Association for Cancer Research (AACR). iTeos will present initial clinical-trial data from a human proof-of-concept study.
The medical community is eager to see if EOS-448 can boost immune system responses to solid tumors by targeting TIGIT receptors found on immune cells. A growing body of evidence suggests TIGIT suppression can boost the efficacy of today's most successful cancer immunotherapies.
In 2020, Roche (RHHBY 0.72%) began a phase 3 trial with its own anti-TIGIT antibody, tiragolumab, in combination with Tecentriq, a treatment that fights cancer by unwinding mechanisms that cancer cells use to hide from the immune system. Roche isn't the only big pharma with deep pockets and drugs like Tecentriq that could use a new sidekick.
It's probably best to watch these biotech catalysts unfold from a safe distance. Encouraging data for EOS-448 could send iTeos shares rocketing higher, but it isn't a guarantee. Clinical trial results interesting enough to earn an early spot at high-profile scientific conferences like AACR aren't necessarily great from an investor's standpoint. It's probably best to wait until after we've seen proof that iTeos' lead candidate can get the job done.
The FDA appears eager to grant approval to aducanumab, but a panel of independent experts assembled to weigh its risks against its benefits strongly objected to its approval, repeatedly. The FDA can overrule the experts, but approving aducanumab would invite more criticism than the agency has ever experienced.
With a market cap up around $13.3 billion, shares of Novavax seem to have priced in a great deal of success for its COVID-19 vaccine already. Positive phase 3 results might push the stock higher in the short term, but the price could still slide over the long run if the company can't meet some lofty manufacturing goals.