The biotech company said the FDA won't review its flu vaccine, in the latest hit to mRNA development.
Amazon (AMZN) acquires a 5.3% stake in BETA Technologies, sharply boosting BETA's premarket share price. Moderna (MRNA) faces an FDA refusal-to-file for its mRNA-1010 influenza vaccine, citing inadequate trial controls but no safety or efficacy issues.
Moderna shares opened 14% lower in Frankfurt on Wednesday in low volume after the U.S. Food and Drug Administration refused to review the company's approval application for its influenza vaccine.
The Food and Drug Administration refused to start a review of Moderna's application for its experimental flu shot, the company said. It's another sign of the Trump administration's influence on tightening vaccine regulation in the U.S.
The company said the agency wouldn't review its application on the grounds that the study testing the shot wasn't sufficient.
In the latest trading session, Moderna (MRNA) closed at $41.95, marking a +2.29% move from the previous day.
MRNA is set to report Q4 results on Feb. 13, with expectations for an earnings beat as COVID vaccine sales and pipeline updates stay in focus.
Moderna (MRNA) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Moderna (MRNA) has been one of the stocks most watched by Zacks.com users lately. So, it is worth exploring what lies ahead for the stock.
Moderna (MRNA) concluded the recent trading session at $42.55, signifying a -3.45% move from its prior day's close.
Moderna, Inc. and Novavax, Inc. have transitioned from pandemic-era highs to focusing on cost reduction, pipeline development, and a path to breakeven by 2028. NVAX leverages partnerships with Sanofi and Pfizer, targeting ~$500m annual revenues by 2030, with a forward P/S of ~3x and P/E of ~7.5x. MRNA's growth depends on COVID/flu combo vaccine, intismeran cancer program, and RSV vaccine, but faces higher risk due to elevated spending and lack of major partners.
Moderna (MRNA) closed the most recent trading day at $47.99, moving 1.48% from the previous trading session.