MODERNA INC. DL-,0001 WKN: A2N9D9 ISIN: US60770K1079 Kürzel: MRNA Forum: Aktien Thema: Hauptdiskussion

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Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review Moderna has received a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026 CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults. Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season. "We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," said Stéphane Bancel, Chief Executive Officer of Moderna. "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu." mRNA-1010 has now been accepted for review in the United States, Europe, Canada and Australia with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to various ongoing regulatory reviews. About Moderna Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.