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Moderna expects US CDC to view its RSV vaccine as equal to rival shots, shares jump – ET HealthWorld | Pharma

By Patrick Wingrove and Leroy Leo

London: Moderna Said on Thursday it expected advisers to the US Centers for Disease Control and Prevention (CDC) to recommend the company respiratory multinucleate virus The (RSV) vaccine will be considered at par with rival shots launched last year.

The Cambridge, Massachusetts-based company is banking on experimental shots To meet the growing demand for Moderna’s only marketed product, Spikevax COVID-19 vaccine.

Moderna shares jumped more than 7 percent in early trading after the company said it expected a “parity recommendation.” PfizerK and GSK’s RSV shots are based on data it has presented and plans to provide.

“We certainly think the data supports it,” Moderna President Stephen Hoge said during a conference call with investors and analysts.

The US Food and Drug Administration will decide whether to approve Moderna or not rsv vaccine, currently named mRNA-1345, is due out by the end of next week. CDC’s panel of external advisers will vote in June on recommendations for its use and intended populations.

A positive decision from both agencies would allow it to compete in the US fall vaccination campaign Against market leaders GSK and Pfizer, which has lagged behind its British rival since launching its RSV shots last year.

Analysts, on average, expect Moderna’s RSV vaccine to generate revenue of $166.67 million in 2024.

GSK and Pfizer together made more than $2 billion in RSV vaccine sales in their first year, although GSK’s Arexvi currently has two-thirds of that new market.

Moderna should be able to gain some market share, “deserving” the consensus estimate for its upcoming shot, said Jefferies analyst Michael Yee.

Moderna is in desperate need of some of its pipeline candidates as its quarterly revenue was just $167 million, down 91 percent from a year ago, when demand for COVID-19 vaccines was high. He still managed to beat Wall Street expectations diminished Of $97.5 million.

Moderna is also working on influenza and cancer vaccines, among other things, and has said it intends to apply to regulators for approval of its flu vaccine this year.

James Mock, Moderna’s chief financial officer, said, “We are encouraged by the performance but recognize this is a small percentage of our overall year as 90 percent of our revenue will come in the second half of the year.”

Moderna also reported a loss of $3.07 per share in the first quarter, less than expected. Analysts had expected a loss of $3.58, according to LSEG data.

Moderna confirms its forecast of sales of $4 billion in 2024, the lowest figure ever Annual revenue Since getting its COVID vaccine US emergency authority At the end of 2020.

(Reporting by Patrick Wingrove in New York and Leroy Leo in Bengaluru; Editing by Sonali Paul and Bill Burkroot)

  • Published on May 3, 2024 at 12:37 PM IST

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