The stock market looked poised to dip to begin Monday morning's trading session, with futures on major indexes significantly lower. Most investors seemed to expect a down opening of around 1% to 2%, with futures on the Nasdaq Composite (^IXIC -1.79%) falling 215 points to 15,573 as of 8:30 a.m. ET.

Many market participants attributed the decline to the omicron coronavirus variant, which has resulted in a new surge of COVID-19 cases in many areas of the world. In response, vaccine stocks were among the best early performers on the Nasdaq, as investors reacted to news of likely approvals of as many tools to fight the disease as possible. However, none of the vaccine stocks rose as much as one biotech company that had some good news beyond the COVID-19 realm. Below, we'll look more closely at how key stocks like Novavax (NVAX -3.74%) and Moderna (MRNA -1.22%) were faring and then turn our attention to Monday morning's big Nasdaq winner.

Vaccine stocks look healthier

It was evident that investors were excited about the prospects for companies making COVID-19 vaccines. Novavax built on strong gains from last week, with its shares rising more than 10% in premarket trading. Moderna was up more than 7%, and the much-smaller Ocugen (OCGN -7.02%) enjoyed a better-than-10% gain.

Medical professional administering shot to patient.

Image source: Getty Images.

Novavax shareholders were paying close attention to regulators in the European Union, who met to determine their views on people using the company's NVX-CoV2373 vaccine. The European Medicines Agency approved its use, finding that studies showing an efficacy rate of roughly 90% were robust enough to warrant moving forward. Novavax now hopes to start delivering large quantities of its vaccine in the first quarter of 2022, while also moving forward with regulatory efforts in other areas of the world to try to maximize its sales opportunity.

Meanwhile, Moderna released data saying its booster dose appeared to offer strong protection against the omicron variant. Study data suggested that levels of neutralizing antibodies were 37 times higher in patients taking a booster compared to those without the booster shot. Moderna also confirmed that it will continue to look at candidate vaccines specifically designed for particular variants such as omicron.

Investors in vaccine stocks have to be prepared for volatility, because as the pandemic progresses, sentiment will change on a dime. For now, though, uncertainty about omicron is supporting stock prices in the industry.

Fighting against depression

However, the big winner in premarket trading Monday was Intra-Cellular Therapies (ITCI -1.70%). The stock was up more than 17% following great news for one of its candidate treatments.

Intra-Cellular announced that the U.S. Food and Drug Administration (FDA) had granted approval for its Caplyta treatment in patients suffering from depressive episodes associated with bipolar disorder in adults. The FDA decision expands its prior approved use of Caplyta in schizophrenia patients.

As a result, medical professionals will be able to prescribe Caplyta for bipolar disorder patients whether they're suffering full manic episodes or shorter hypomanic episodes. It can be used either on its own or in conjunction with other common therapies for depression such as lithium or valproate. Intra-Cellular is ready to move forward with a marketing launch immediately, according to CEO Sharon Mates.

Caplyta has already been an early success for Intra-Cellular, but today's news gives the biotech access to a much larger market. Investors are hopeful that this will result in a big sales surge in the months to come.