Moderna Announces Update on Investigational RSV Vaccine [Yahoo! Finance]
Moderna, Inc. (MRNA)
Last moderna, inc. earnings: 2/26 07:00 am
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Source: Yahoo! Finance
Agency has indicated it expects to complete the review by end of May CAMBRIDGE, MA / ACCESSWIRE / May 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345, Moderna's investigational respiratory syncytial virus (RSV) vaccine, by the previously communicated Prescription Drug User Fee Act (PDUFA) date of May 12, 2024. The FDA has informed Moderna that it is working to conclude the review by the end of May 2024. The FDA has not informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345. Moderna remains on track for mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices (ACIP) June 26-27, 2024, meeting, which is necessary prior to commercial launch. "Moderna is very grateful to
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News
- Does AI Really Make Moderna Stock (NASDAQ:MRNA) a Buy? [Yahoo! Finance]Yahoo! Finance
- Moderna wins COVID shot patent case against Pfizer-BioNTech in Europe [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- European Patent Office Sides with Moderna In COVID-19 Vaccine Patent Dispute With Pfizer/BioNTech [Yahoo! Finance]Yahoo! Finance
- Moderna vaccine patent upheld by European Patent Office: report [Seeking Alpha]Seeking Alpha
- Moderna, Inc. (NASDAQ: MRNA) was upgraded by analysts at Evercore ISI to a "hold" rating.MarketBeat
MRNA
Earnings
- 5/2/24 - Beat
MRNA
Sec Filings
- 5/17/24 - Form 4
- 5/17/24 - Form 4
- 5/15/24 - Form 144
- MRNA's page on the SEC website