Moderna (NASDAQ:MRNA) shares are moving higher on Monday after the company won FDA Fast Track status for an oncology program, helping the stock hold up even as major indices trend lower. The move comes while the Nasdaq is sliding 0.59% and the S&P 500 is down 0.33%.

FDA Grants Fast Track Designation To Treatment

The FDA granted Fast Track designation to Moderna's mRNA-4359 combination program following early melanoma trial results, a regulatory step that can speed development and review timelines. The headline puts fresh attention on Moderna's oncology pipeline as investors weigh what "faster path" signals could mean for future milestones.

“This study evaluating mRNA-4359 + pembrolizumab as a first-line treatment option reflects our ambition to demonstrate the potential of mRNA technology throughout a cancer patient’s journey. While conducted among a small patient population, we are encouraged by the high response rates and mechanistic translational results,” said David Berman, chief development officer at Moderna.

What’s Next For Moderna?

Moderna is due to report first-quarter earnings before the market open on May 1. Here’s a look at current analyst estimates:

  • EPS Estimate: $-2.51 (Up from $-2.52 YoY) – EPS expectations of $-2.51 represent a slight improvement, but investors will be looking for evidence that losses are narrowing as the company adapts to changing market dynamics.
  • Revenue Estimate: $240.52 million (Up from $108.00 million YoY) – Revenue of $240.52 million would validate Moderna’s efforts to rebound from previous lows and signal that its vaccine offerings are still relevant in a shifting landscape.

Investors should keep an eye on vaccine sales trends, particularly in the context of ongoing public health campaigns and booster shots. Additionally, watch for any updates on new vaccine candidates or partnerships that could enhance Moderna’s pipeline and market position. Finally, monitor the company’s cash burn rate, especially given the anticipated revenue fluctuations, to gauge its financial health moving forward.

Moderna stock carries a consensus Hold Rating with an average price target of $33.23. Notable recent analyst moves include:

  • Barclays: Equal-Weight (Raised Target from $25.00 to $48.00) (April 2)
  • Piper Sandler: Overweight (Raised Target from $63.00 to $69.00) (Feb. 23)
  • Goldman Sachs: Neutral (Raised Target from $36.00 to $41.00) (Feb. 17)
  • RBC Capital: Sector Perform (Raised Target from $25.00 to $30.00) (Feb. 17)
  • Evercore ISI Group: In-Line (Raised Target from $28.00 to $35.00) (Feb. 17)

MRNA Shares Rise Monday

MRNA Price Action: Moderna shares were up 1.56% at $54.56 at the time of publication on Monday, according to Benzinga Pro data.

Image: Shutterstock