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738,451 Results for "moderna therapeutics inc".
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Vaccines
Flu Vaccine Rejection Imperils Moderna’s Breakeven Plans
Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.
February 12, 2026
·
4 min read
·
Dan Samorodnitsky
FDA
Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
February 13, 2026
·
6 min read
·
Heather McKenzie
Earnings
Moderna’s FDA Challenges Stymie Breakeven Goal in ‘Fresh and Fluid’ Situation
Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
February 13, 2026
·
5 min read
·
Annalee Armstrong
Editorial
All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
February 11, 2026
·
4 min read
·
Dan Samorodnitsky
Vaccines
FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
February 11, 2026
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4 min read
·
Tristan Manalac
FDA
FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
February 12, 2026
·
2 min read
·
Dan Samorodnitsky
Regulatory
HHS Backs Prasad Amid Moderna Flu Shot Blowback
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
February 12, 2026
·
2 min read
·
Tristan Manalac
Business
Moderna Hits 2025 Revenue Goal as Operating Costs Fall Faster than Forecast
While Moderna’s full-year sales landed in the upper end of its target range, Jefferies analysts said further reductions are needed if the biotech hopes to hit its 2028 break-even target.
January 12, 2026
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2 min read
·
Nick Paul Taylor
Deals
Moderna Teams With Recordati on Rare Disease mRNA Therapy for up to $160M
Moderna will continue to lead clinical development and manufacturing of the asset, while Recordati will handle commercialization of mRNA-3927, which is under development for the rare metabolic disorder propionic acidemia.
January 30, 2026
·
1 min read
·
Annalee Armstrong
Vaccines
Moderna Won’t Run Phase III Vaccine Trials as Skepticism Grows in US: Bloomberg
Growing opposition to vaccines in the U.S., driven by recent government policy changes, makes it difficult to see a return on investment in vaccine development, Moderna CEO Stéphane Bancel said this week.
January 23, 2026
·
2 min read
·
Tristan Manalac
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